regulatory disorders in early childhood: correlates in child behavior, parent–child relationship,...

A R T I C L E

REGULATORY DISORDERS IN EARLY CHILDHOOD: CORRELATES IN CHILD

BEHAVIOR, PARENT–CHILD RELATIONSHIP, AND PARENTAL MENTAL HEALTH

CHRISTIAN POSTERT, MARLIES AVERBECK-HOLOCHER, SANDRA ACHTERGARDE, JORG MICHAEL MULLER,TILMAN FURNISS

Department of Child and Adolescent Psychiatry, Psychosomatic Medicine and Psychotherapy

ABSTRACT: According to the guidelines published by the German Society of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy(2007), regulatory disorders of early childhood are characterized by a symptom triad, including (a) behavioral symptoms such as excessive crying,sleeping, or feeding problems; (b) a disturbed parent–child relationship; and (c) parental psychopathology. On the basis of a clinic–referred sample of162 children, we examined whether children with and without regulatory symptoms differed in the quality of parent–child relationship and parentalmental health, and how often the criteria of the symptom triad were fulfilled in the group of children with regulatory symptoms. In addition, emotionaland behavior problems were compared in children with and without regulatory symptoms. Children with regulatory symptoms and children with otherpsychiatric symptoms did not differ with respect to child–parent relationship quality. However, parents of children with regulatory symptoms scoredhigher on the Symptom Checklist 90 Items-Revised (G.H. Franke, 2002) than did the other parents. On the Child Behavior Checklist (T.M. Achenbach& L.A. Rescorla, 2000), children with regulatory symptoms tended to show more somatic problems, but they showed significantly less withdrawnbehavior than did the other children. Of the 67 children with regulatory symptoms, only 11 (16.4%) fulfilled all three criteria of a regulatory disorder.

Abstracts translated in Spanish, French, German, and Japanese can be found on the abstract page of each article on Wiley Online Library athttp://wileyonlinelibrary.com/journal/imhj.

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Over the last 15 years, regulatory disorders of early childhoodhave attracted the increased attention of researchers and practi-tioners in infant psychiatry (Papousek, 2003). Compared to otherage groups, infants and toddlers represent the group most vari-able in developmental changes in emotion regulation and inter-personal interactions. Given the tremendous variation according toneurodevelopmental maturation and environmental circumstances,they have the broadest degree of variation with respect to sleep-ing, feeding, crying, agitation, and other aspects of emotional andbehavioral regulation. The immature self-regulatory abilities ofyoung children often lead to phases of increased activity, opposi-tional behavior, impulsiveness, and aggressive behavior. For somechildren, these are transient features of normal development; theycease as self-regulatory skills mature (Keenan & Wakschlag, 2000).For other children, these behaviors persist as symptoms of regu-latory disorders, which ought to be diagnosed as early as possible(Lavigne et al., 1998). DeGangi, Porges, Sickel, and Greenspan(1993), in their prospective 4-year longitudinal study, described aprogression of regulatory symptoms to substantial developmental,sensorimotor, and/or emotional and behavioral deficits at 4 years

Direct correspondence to: T. Furniss, Department of Child and Adolescent Psy-chiatry, University Hospital Muenster, Schmeddingstrasse 50, 48149 Muen-ster, Germany; e-mail: [email protected].

suggesting that untreated regulatory-disordered infants may notoutgrow behavioral difficulties over time. Wolke, Rizzo, andWoods (2002) suggested a progression of crying disorder in earlychildhood to the diagnostically relevant areas of hyperactivity andconduct disorder at school age. However, more longitudinal re-search is needed to study the developmental psychopathologicalsignificance of regulatory symptoms.

To distinguish between transient developmental perturbationsof regulation and persisting psychopathology at preschool age, de-velopmentally sensitive and age-specific diagnostic criteria are re-quired. A nosological category of regulatory disorder for preschoolchildren badly needs operationalized criteria for onset and du-ration of symptoms of regulation disturbances, setting clear andempirically derived boundaries for clinical symptoms beyond nor-mative variation (Papousek & von Hofacker, 1998). As such cri-teria do not exist at present, this category has not yet been in-cluded into standard classification systems such as the Diagnosticand Statistical Manual for Mental Disease, fourth edition (DSM-IV; American Psychiatric Association, 1994) or the InternationalStatistical Classification of Diseases and Related Health Prob-lems, 10th revision (ICD-10; World Health Organization, 1992).The Diagnostic Classification of Mental Health and Developmen-tal Disorders of Infancy and Early Childhood: Revised Edition(DC: 0–3R, ZERO TO THREE, 2005), a multi-axial classification

INFANT MENTAL HEALTH JOURNAL, Vol. 33(2), 173–186 (2012)C© 2012 Michigan Association for Infant Mental HealthView this article online at wileyonlinelibrary.com.DOI: 10.1002/imhj.20338

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174 • C. Postert et al.

TABLE 1. Diagnostic Criteria of Regulation Disorders of Sensory Processing, Sleep, and Feeding Behavior Disorders According to DC: 0–3R (ZEROTO THREE, 2005)

400 Regulation Disorders of Sensory Processinga

(1) Sensory Processing Difficulties (2) Motor Difficulties (3) Specific Behavior Pattern

410 Hypersensitive411 Type A: Fearful/cautious Overreactivity to sensory stimuli; may,

for example, react with fearfulness,crying, aggression

May show difficulties in fine-motorcoordination; less exploration;limited sensorimotor play

Distress when routines change, fearand clinginess in new situations,shyness, irritability

412 Type B: Negative/defiant Identical to Type A Identical to Type A Negativistic behavior (fussing),defiance, compulsiveness

420 Hyposensitive/underresponsive Underreactivity to sensory stimuli,sensations, and social overtures

Limited exploration, restricted playrepertoire, repetitive activities,lethargy

Lack of interest in exploring,apathetic appearance,inattentiveness

430 Sensory stimulation-seeking/impulsive Craving for high-intensity sensorystimuli

High need for motor discharge,diffuse impulsivity, accidentproneness

High activity level, seeking contactand stimulation, reckless oraggressive behavior

500 Sleep Behavior Disorder510 Sleep-onset disorder • Significant difficulty falling asleep

• Must be present for at least 4 weeks,with 5 to 7 episodes per week

• Child must be 12 months of age orolder

520 Night-waking disorder • Significant difficulty in awakeningsthat require parental interventionand/or removal to the parental bed

• Must be present for at least 4 weeks,with 5 to 7 episodes per week

• Child must be 12 months of ageor older

600 Feeding Behavior Disorder601–606b • Should be considered when an infant

or young child has difficultyestablishing regular feedingpatterns/does not regulate his or herfeeding in accordance withphysiological feelings of hunger orfullness

• Requires absence of hunger,separation, negativism, or trauma

aThe symptoms listed here are exemplary; for a comprehensive enumeration, see the original literature (ZERO TO THREE, 2005).bDetails about the six subtypes of feeding behavior disorder are not listed here due to lack of space. For more information, see the original literature (ZERO TO THREE,2005).

system for the diagnosis of psychiatric disorders in the first 4 yearsof life, explicitly considers regulatory disorders, albeit referringto them as “regulation disorders of sensory processing” (p. 28)(Table 1). Focusing on clinical usefulness, the authors of the DC:0–3R included this diagnostic category, which they deemed to berelevant from clinical expertise but which still lacks systematicempirical proof and evidence-based data (DeGangi & Breinbauer,1997; DeGangi, Breinbauer, Roosevelt, Porges, & Greenspan,2000). Those children affected are presumed to have constitu-tional and developmental deficits in sensory, sensomotoric, andemotional processing.

Some research studies have made parallel use of the preschool-age DC: 0–3 and the DSM-IV, where a comparable categorical

equivalent of regulatory disorder does not exist. This use of paral-lel codification systems found that cases diagnosed as regulatorydisorder under the DC: 0–3 were under the DSM-IV, in the major-ity of cases classified as disruptive disorder and in a minority ofcases as emotional or adjustment disorder (Dunitz, Scheer, Kvas,& Macart, 1996; Frankel, Boyum, & Harmon, 2004; Thomas &Clark, 1998; Thomas & Guskin, 2001).

In the long research process of construct validation, the ab-sence of evidence should not be considered as invalidating a noso-logical category such as regulatory disorder, whose face validitywas derived from clinical consensus and expertise. The processof validation depends on preliminary nosological categories pro-viding a conceptual framework for making clinical hypotheses,

Infant Mental Health Journal DOI 10.1002/imhj. Published on behalf of the Michigan Association for Infant Mental Health.

Regulatory Disorders in Early Childhood • 175

which can then be validated or invalidated in ongoing research.This involves attempting to demonstrate that a distinctive patternof symptoms is associated with specific genetic, neurobiological,psychological, and psychosocial correlates. Therefore, the descrip-tive attempt to classify regulatory symptoms in preschool childrenis not an end in itself but the means to understanding etiologicmechanisms and to derive appropriate intervention strategies(Postert, Averbeck-Holocher, Beyer, Muller, & Furniss, 2009).

However, apart from the lack of a thorough empirical val-idation of this diagnostic category, there are several conceptualproblems about diagnosing regulatory disorders on the basis of theDC: 0–3R. First, in the current literature on infant mental health,the term regulation disorder is not common. Instead, the term reg-ulatory disorder is widely used, but mainly as a generic term whichalso includes feeding and sleeping symptoms and excessive crying(Papousek, 2003; von Hofacker & Papousek, 1998). Second, incontrast to sleeping and feeding disorders, excessive crying/colicis not mentioned as a distinct category in the DC: 0–3R; yet, inthe current literature, this behavior is considered as an importantregulatory symptom (Desantis, Coster, Bigsby, & Lester, 2004;von Hofacker & Papousek, 1998; Wurmser, Laubereau, Hermann,Papousek, & von Kries, 2001). Third, the DC: 0–3R claims that–regulatory problems are “constitutionally based responses” (ZEROTO THREE, 2005, p. 28). This assertion meshes etiological issuesinto diagnostic criteria, which should rather be descriptive (TaskForce on Research Diagnostic Criteria: Infancy and Preschool,2003). Finally, specific criteria of the types and subtypes of regula-tion disorders (Table 1) are lacking, which reduces reliability andvalidity of the diagnoses. Taken together, these problems indicatethat the DC: 0–3R concept of “regulation disorders” is not yet fullydeveloped and requires further research.

ALTERNATIVE CONCEPT: THE SYMPTOM TRIAD

In the ICD-10, the DSM-IV, and the DSM-IV’s extensioninto preschool age, the Research Diagnostic Criteria-PreschoolAge (Task Force on Research Diagnostic Criteria: Infancy andPreschool, 2003), the authors formulated diagnostic categories assyndromes that are made up of phenomenological symptom clus-ters of the individual child independent of possible contributingetiological factors pertaining to the child and to behavior pattern ofparents. In attempting to achieve a phenomenological-objective de-scription of disorder symptoms, the importance of interactive fac-tors as risk factors is never in question but doubt is cast on whetherthey can be operationalized for use in research studies (TaskForce on Research Diagnostic Criteria: Infancy and Preschool,2003).

The DC: 0–3 wants to stress the relational nature of regulatorydisorders. However, it is obvious that psychopathology is assumedto apply only to the child. As in conventional classification systems,interactional factors such as maladaptive parent–child interactionare not integrated into the disorder category of regulatory disorder,but coded as a risk factor to confine the disorder definition toindividual illness categories.

TABLE 2. Leading Behavioral Symptoms of Regulatory Disorders(German Society of Child and Adolescent Psychiatry, Psychosomaticsand Psychotherapy, 2007)

• Excessive crying or agitation (with or without symptoms of colic) in the first sixmonths of life

• Sleeping disorders in the first 3 years of life• Feeding disorders in infant and preschool age• Reluctance or inability to play combined with chronic agitation• Persistent and exaggerated shyness with strangers, clinging behavior, fear• Excessive oppositional behavior, temper tantrums• Aggressive behavior• Lack of interest, apathy, depression

An alternative transactional concept of defining and diagnos-ing regulatory disorders has been proposed jointly by the threemajor German child psychiatric societies: the German Society ofChild and Adolescent Psychiatry, Psychosomatics and Psychother-apy; the Board of Department Heads in Child and Adolescent Psy-chiatry, Psychosomatics and Psychotherapy; and the ProfessionalAssociation of Child and Adolescent Psychiatrists, PsychosomaticTherapists and Psychotherapists in Germany (German Society ofChild and Adolescent Psychiatry, Psychosomatics and Psychother-apy, 2007). According to their guidelines, regulatory disordersare conceived as disorders of the interaction between infants andtoddlers and their parents. In the framework of this transactionalapproach, the dependency of the child’s emotional and behav-ioral regulation on the interactional regulation in the parent–childdyad is stressed. The aim is not to focus on infant or toddler psy-chopathology but on the relational pathology of a dysfunctional,nonregulative parent–child dyad.

Despite etiological considerations, the guidelines stick to adescriptive approach identifying phenomenological symptom clus-ters. According to the authors, regulatory disorders of early child-hood are characterized by a “typical combination,” a symptom triadof

• infant behavioral problems (see Table 2),• dysfunctional interaction processes between parents and

child, and• severe parental distress.

The guidelines are conceived as a tool for clinical purposes.The quality of the pathological symptom cluster is indicated, butno threshold of symptom intensity or frequency qualifying fordiagnosis of regulatory disorder is specified. As an exception tothis, the child’s symptoms in regulatory disorders of crying, feed-ing, and sleeping are operationalized by exact time frames forsymptom behavior, such as 3 hr of daily crying in more than3 days per week in more than 3 consecutive weeks for the reg-ulatory disorder of crying. Although generally open to postu-lated disorder categories, the DC :0–3R offers no correspondingdiagnostic categories specific for infants under 1 year. “Cryingdisorder” is not mentioned at all, as neither sufficient scientific



evidence nor clinical consensus exist to establish crying disor-der as a distinct child psychiatric category. Few studies havebeen conducted to date in this area (Maldonado-Duran &Saudera-Garcia, 1996). Some research has suggested a progressionof crying disorder in early childhood to the diagnostically relevantareas of hyperactivity and conduct disorder at school age (Wolkeet al., 2002). In addition to a thorough empirical validation of thediagnostic category of crying disorder, its developmental psy-chopathological significance needs to be longitudinally researchedto empirically verify this possible link. Despite its hypotheticity,the guidelines’ downward extension of regulatory disorders intodisorders of crying, feeding, and sleeping of the first year of lifeappears to be reasonable for the clinical usefulness of a diagnosticmanual. Hopefully, the postulation of this hypothetical nosologicalcategory will stimulate further research in this area.

As in most descriptive disorder categories, the method of datacollection is generally not specified in the guidelines. An excep-tion to this is the suggestion to supplement clinical diagnosis of thechild’s symptoms by administration of the Child Behavior Check-list 1–5 (Achenbach & Rescorla, 2000; German version: Arbeits-gruppe Deutsche Child Behavior Checklist, 2000) and to apply theParent–Infant Global Assessment Scale (PIR-GAS; Aoki, Zeanah,Heller, & Bakshi, 2002) for parent–child relationship assessment.It remains open how to assess parental distress, what contributionself-reported measures versus observation could offer, in what set-tings observations of parent–child interactions are to be conducted,how structured the observations are to be, and so on. The reliabil-ity of the diagnosis can be assumed to be hampered by this lackof operationalized diagnostic criteria and assessment procedures.Angold and Fisher (1999) noted that clinicians have been knownto assign different diagnoses to one and the same sample of pa-tients when unstructured data-collection methods were used. Asthe evaluation of the validity of the regulatory disorder categorywould be extremely difficult to determine if the diagnostic criteriawere unreliable, the improvement in the categories’ reliability istherefore of undisputed importance in the further development ofthis disorder category.

To a large extent, empirical data such as clinical expert opin-ion in the evolving field of preschool mental health may be insuffi-cient and may need to be corroborated by independent systematicresearch. However, in many nosological categories, clinical ex-pert opinion represents the best empirical evidence available atpresent. To exclude clinical diagnoses such as regulatory disor-der, which have not yet been sufficiently scientifically validated,from a classification system would increase the relative propor-tion of evidence-based criteria within a system, but diminish thecoverage of disorder phenomena and impinge on clinical useful-ness and the scope for hypothesis-generating research (Emde et al.,2005).

In this article, we will present an explorative study which aimsat testing the feasibility of the symptom-triad criterion on the basisof data from a clinical sample. Before presenting our own results,we will report on empirical findings from the current literature onregulatory disorders.

PREVALENCE AND DEVELOPMENT OF REGULATORYDISORDERS

Skovgaard et al. (2007) examined the prevalence of regulatory,eating, and sleeping disorders according to DC: 0–3 criteria (ZEROTO THREE, 1994) in the general population. They observed aprevalence of 7.1, 2.4, and 1.4%, respectively, which means thatsymptoms of the regulatory spectrum occur quite frequently amongotherwise healthy infants. Mothander and Moe (2008) included aclinical sample of 0- to 3-year-old children who were referred toa Scandinavian outpatient clinic. They found regulatory disordersaccording to DC: 0–3 (ZERO TO THREE, 1994) in 19% of thechildren. In a clinical trial by Minde and Tidmarsh (1997) on 57children between 15 to 48 months of age, 37% met the criteriafor regulation disorders. These exploratory studies have stronglysupported the notion that regulatory symptoms are frequent in thisage group.

Some researchers and clinicians have assumed that regulatorydisorders are self-confined and will subside without any aftermathwhen the child gets older (Stifter & Braungart, 1992); however,Wurmser et al. (2001), for example, showed that excessive crying,which was believed to decrease after the third month of life, per-sisted longer than expected in almost 40% of the children. Desantiset al. (2004) conducted a longitudinal study with children who werereferred for treatment because of excessive crying/fussing at age 4to 12 weeks. At follow-up, when these children were 3 to 8 yearsold, 75% of them still showed atypical responses to sensory ex-periences, which was indicative of persisting regulatory problems.These findings imply that regulatory symptoms and related prob-lems may well persist beyond infant and toddler age. Hence, in ourstudy, we include children until the end of preschool age (i.e., upto 6 years) to see whether and how often regulatory symptoms stillemerge in this age group.

PARENT–CHILD RELATIONSHIP AND PARENTAL MENTALHEALTH

The role of the infant’s and small child’s immediate relational en-vironment as a major determinant of his or her mental health devel-opment and well-being is of undisputed importance (Cicchetti &Toth, 1998; Emde et al., 2005; Wakschlag & Keenan, 2001). Olson,Bates, Sandy, and Lanthier (2000) and Shaw, Owens, Giovannelli,and Winslow (2001) demonstrated the interplay of biological andrelational factors in the pathogenesis of early childhood mentalillness between a child’s difficult temperament and negativity inthe mother–child interaction in externalizing disorders. In earlychild mental health development, biological and relational factorsclosely interact, requiring a dynamic model of mental health de-velopment (Rutter, 2006; Schore 2003a, 2003b; van der Valk, vanden Oord, Verhulst, & Boomsma 2003). Because of the effects ofthese risk factors on diagnosis, treatment, and prognosis, it wouldbe important in clinical practice to take into account the contex-tual factors influencing developmental psychopathology in youngchildren; that is, child–parent attachment, parental sensitivity, andinteractive behavioral patterns (Frankel et al., 2004). However, the



difficulty of developing reliable measurements of relationship fac-tors remains a serious empirical challenge (DelCarmen-Wiggins& Carter, 2004). Although it is possible to use the multiaxialDSM-IV and ICD-10 classification systems to collect data on theenvironmental factors contributing to mental illness, the individualpatient and his or her symptoms remain the primary focus ofthe clinician’s attention. Substantial methodological challenges ofvalid and reliable measurement of relationship factors are stillunresolved.

The DC: 0–3 and DC: 0–3R were devised as multiaxial clas-sification systems building on the five axes of the DSM-IV classi-fication. Axis II of the DSM-IV refers only to developmental andpersonality disorders, the DC: 0–3 and DC :0–3R go further intheir formulation of a relationship disorder classification. Here,in addition to the standard diagnostic interview, observational as-sessment of parent–child interaction is designed to screen for in-teractional behavior detrimental to the child’s mental health anddevelopment. For this purpose, the PIR-GAS, a semiquantitativeassessment tool for evaluating the parent–child relationship, wasdeveloped in the DC: 0–3. In studies conducted by Minde and Tid-marsh (1997) and Keren, Feldman, and Tyano (2001), 53 to 73% ofa clinical sample satisfied criteria for the diagnosis of relationshipdisorder.

Several studies have confirmed the correlation between regu-latory disturbances and disorders in the parent–child relationship.For instance, in their epidemiological study of a Danish general-population sample, Skovgaard et al. (2007) found a rate of 8.5%for child–parent relationship disorders, with a significant associa-tion to regulatory disorder, hyperactivity/attention deficit disorder,reactive attachment disorder, and disorder of conduct and emo-tions. Thomas and Clark (1998) found that disorders of affect weresignificantly more likely to occur in combination with relationshipdisorders than with disorders of regulation or posttraumatic stressdisorder.

von Hofacker and Papousek (1998) compared the relation-ship quality in mother–child dyads with infants who had beenreferred because of excessive crying/fussing behavior to mother–child dyads with healthy infants. Relationships in dyads with areferred infant were significantly more often classified as “dis-turbed” or “disordered” than were those in the control group (85.5vs. 10.2%). The authors concluded that regulatory symptoms affectthe mother–child relationship by interfering with the communica-tion between parent and child and hampering intuitive parentingbehavior.

von Hofacker and Papousek (1998) also found evidence forimpaired mental health in parents of children with regulatory symp-toms. Maternal psychopathology (depression, neurotic disorders,and personality disorders) was observed in about 50% of the chil-dren who cried excessively, but only in 3% of the mothers ofthe control group. Furthermore, the mothers of the excessivelycrying infants reported high anxiety during pregnancy. The rela-tion between regulatory symptoms, parental mental health, andthe parent–child relationship was confirmed in further studies(Papousek, 2003; Stifter & Bono, 1998).

It appears straightforward to develop therapeutic conceptsto improve parent–infant interaction to treat infant symptomatol-ogy. Cohen et al. (1999) evaluated the Watch, Wait, and Wonderprogram, an infant-led psychodynamic psychotherapy with directinclusion of the infant as an initiator of interaction, and found it tobe to be superior to mother–infant psychodynamic therapy, whichtends to focus primarily on the more verbal partner, the parent.Improvement of the parent–infant interaction was associated witha broad range of outcome variables, including decreased mater-nal depression, gains in infant cognitive development and emo-tion regulation, and improved infant–mother attachment security.These positive effects were stable or improved further in a 6-monthfollow-up (Cohen, Lojkasek, Muir, Muir, & Parker, 2002).

Recent work on the subject of affect regulation has confirmedthe importance of parent–child interaction for the child’s mentalhealth as the child’s regulatory capacities depend on the parent’s in-tuitive coregulatory competence that may be hampered by parentalpsychiatric or relationship disorders (Schore, 2003a, 2003b;Fonagy, Gergely, Jurist, & Target, 2002).

Without assuming a lineal causal relationship between child’smental health, parental mental health, and relationship disorder,we will examine whether these associations exist and whether theyare specific to regulatory symptoms; that is, whether children withregulatory symptoms and children with other symptoms differ withrespect to parent–child relationship quality and parental mentalhealth.

BEHAVIOR PROBLEMS

Several authors have found more behavior and interaction prob-lems in children who had been diagnosed with colic/excessivecrying as infants compared to those who had not (Canivet,Jakobsson, & Hagander, 2000; Wolke et al., 2002). In our study, wewill examine which additional emotional and behavior problemsthat were assessed with the Child Behavior Checklist for preschool-ers (CBCL/1.5–5; Achenbach & Rescorla, 2000) are present inyoung children with regulatory symptoms. These problems will becompared to behavior problems detected in young children withother psychiatric symptoms.

OVERVIEW OF THE AIMS OF THE STUDY

The overall aim of this explorative study was to adopt the symptom-triad approach to regulatory disorders in a clinical sample of youngchildren and their parents. We will examine how often regulatorysymptoms such as excessive crying, agitation, sleeping, and feed-ing problems occur among clinic-referred children under 6 years ofage as well as how many of the children with regulatory symptomsfulfill all three criteria of the symptom triad. In addition, we will ex-amine whether and how children with regulatory symptoms differfrom children who present with any other psychiatric symptoms;namely, with respect to the parent–child relationship, parental psy-chopathology, and emotional and behavioral symptoms, assessedby the CBCL/1.5–5 (Achenbach & Rescorla, 2000).



METHOD

The Child Psychiatric Family Day Hospital in Munster, Germanyis part of the Department of Child and Adolescent Psychiatry atMunster University Hospital and is characterized by its focus onearly treatment of psychiatrically disturbed children from infancyto preschool age. It offers treatment facilities for 12 preschoolchildren and their families. The Family Day Hospital is led by asenior consultant in child and adolescent psychiatry. Other teammembers include child psychiatric interns, developmental psychol-ogists, occupational therapists, psychomotor therapists, and spe-cially qualified nurses. The special kind of child–parent inpatienttreatment in the child psychiatric family hospital has to be distin-guished from mother-baby units in adult psychiatry which are in-tended for the primary treatment of adult psychiatric disorders suchas postpartum depression or postpartum, psychosis (e.g., Cazas& Glangeaud-Freudenthal, 2004; Milgrom, Burrows, Snellen,Stamboulakis, & Burrows, 1998; Wan, Warburton, Appleby, &Abel, 2007). In Germany, the involvement of parents in the treat-ment of their psychiatrically ill children is officially recognized,and the financial costs are fully met by all health insurance systemsby formulating the assessment and treatment needs according tothe accounting order of the compulsory health insurance funds andthe renumeration structure for private medical services.

Data were collected during a 10-year-period between 1997 and2007. The study included 162 children between 1.5 and 5.9 yearswho were successively referred as patients to the Family Day Hos-pital during these years. Although some families referred morethan one child for treatment, only the first child of each family wasincluded into this analysis to avoid confounding effects.

Subjects

Children. Of the 162 children who were included into the study,115 were boys (71.0%) and 47 were girls (29.0%). The mean ageof the children was 4.2 years (SD = 1.2) or 51 months (SD =14.7), respectively. The mean age of boys was 4.3 years (SD =1.2/SD = 14.3), and the mean age of girls was 4.1 years(SD = 1.3/SD = 15.7). Boys and girls did not differ significantlywith respect to age.

A total of 156 children (96.3%) were German, 4 (2.5%) werefrom other European Union nations, and 2 (1.2%) were fromnon-European Union nations. One hundred twenty-eight children(80.0%) lived with both parents, 31 (19.4%) children lived in asingle-parent family, and 1 child (0.6%) lived in a residential chil-dren’s home. Fifty-three (32.7%) children were the only child intheir family, 83 (51.2%) children had one sibling, 19 (11.7%) hadtwo siblings, and 7 (4.4%) had three or more siblings.

Parents. Each child was accompanied by a parent (n = 162) whowas involved in treatment. Information about the second parent wasprovided by the primary caregiver. Among them were 161 mothers(99.4%) and 1 father (0.6%).

Maternal age ranged from 19 to 49 (M = 33.2, SD = 5.9)years. Information about school education was available from 77

mothers. Of these, 24 (31.2%) had completed grammar school(12–13 years of education), 25 (32.5%) had completed secondarymodern school (10 years of education), and 28 (36.4%) had com-pleted secondary school (9 years of education). Paternal age rangedfrom 21 to 56 (M = 36.6, SD = 6.8) years. Information about schooleducation was available from 48 fathers. Of these, 22 (45.8%) hadcompleted grammar school, 7 (14.6%) had completed secondarymodern school, and 19 (39.6%) had completed secondary school.

Measure

Clinical diagnostic with children was led by a consultant child psy-chiatrist and included an assistant doctor and a child psychother-apist of the Family Day Hospital. Parents completed the BeckDepression Inventory (BDI; German version: Hautzinger, Bailer,Worall, & Keller, 1995) and the Symptom Checklist 90 Items-Revised (SCL 90-R; Franke, 2002). Child symptoms were dimen-sionally assessed by the CBCL/1.5-5 (Achenbach & Rescorla,2000). Regulatory symptoms and quality of parent–child relation-ship were assessed and rated by clinical consensus involving agroup of experienced clinicians (each with a minimum of 2 yearsof working experience in our Family Day Hospital for preschoolchildren). Supervised by the same senior consultant in child andadolescent psychiatry since 1997, a standard procedure for as-sessing regulatory symptoms in preschool children and quality ofparent–child relationship was applied that usually took 60 min. Thesenior consultant in child and adolescent psychiatry, child psychi-atric interns, developmental psychologists, occupational therapists,psychomotor therapists, and specially qualified nurses then jointlyassessed psychopathological status including regulatory symptomsfor each child 3 weeks after admission by comparing specific video-taped interaction sequences of the child in child-to-parent interac-tion, child-to-child interaction, and child-to-therapist interactionin structured and nonstructured situations. In the case of crying,sleeping, or feeding dysregulation, observation diary sheets thathad been filled out by the parents for up to 3 weeks also were eval-uated. These diary sheets helped to quantitatively assess frequencyand duration of dysregulated interaction sequences (see Figure1). Additional clinical observations and descriptions from parentsor daycare centers were discussed as a therapeutic team. Onlychildren who were jointly rated as having moderate or severe reg-ulatory symptoms were included in our study subgroup of childrenwith regulatory disorders. The quality of parent–child relationshipwas jointly rated on the basis of the PIR-GAS rating systemexceeding minimum recommendations stated by the guidelines.

CBCL. Children were rated by their parents on the German ver-sion of the CBCL/1.5–5 (Achenbach & Rescorla, 2000; Germanversion: Arbeitsgruppe Deutsche Child Behavior Checklist, 2000).The CBCL scales are widely accepted instruments for assessingbehavioral and emotional symptoms in children of different ages(Rescorla, 2005). The CBCL/1.5–5 consists of 100 items that arerated by parents on a 3-point scale (0 = not true, 1 = somewhator sometimes, and 2 = very true or often true). The questionnaireyields T-scores on seven empirically based scales (Emotionally



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FIGURE 1. Record sheet for diary observations.

Reactive, Anxious/Depressed, Somatic Complaints, Withdrawn,Attention Problems, Aggressive Behavior, and Sleep Problems)and three broadband scales (Internalizing, Externalizing, and TotalProblems) with proven reliability and validity.

PIR-GAS. The quality of the relationship between parent and childwas rated by the PIR-GAS (Aoki et al., 2002; ZERO TO THREE,1994). The higher the distress or suffering in parent or child, thelower the resulting score on a scale from 90 to 10 (see Table 3).Ratings between 10 and 30 indicate severe relationship disorders(ZERO TO THREE, 1994).

TABLE 3. Parent–Infant Global Assessment Scale (PIR-GAS; Aoki,Zeanah, Heller, & Bakshi, 2002) Rating Scores

Score PIR-GAS Label Description of Relationship

Adapted relationshipa

90 Well-adapted Functioning exceptionally well.80 Adapted Functioning without signs of pathology.70 Perturbed Transiently functioning less than optimally

in some ways.Disturbed relationshipa

60 Significantly perturbed Strained in some areas, but not severely orpervasively.

50 Distressed More than transiently affected.40 Disturbed At significant risk for dysfunction.Disordered relationshipa

30 Disordered Relatively stable, maladaptive interactionsand distress.

20 Severely disordered Severely compromised. Maladaptiveinteractive patterns.

10 Grossly impaired Disorganized. Danger of physical harm tothe child.

aAccording to von Hofacker & Papousek (1998).

According to von Hofacker, Jacubeit, Malinowski, andPapousek (1996), PIR-GAS scores between 40 and 60 indicatea “disturbed” relationship while scores between 70 and 90 indi-cate an “adapted” relationship. Note that a revised version of thePIR-GAS has been published, featuring a different scoring scale(ZERO TO THREE, 2005), but was not available at the time ofdata collection.

SCL 90-R . The SCL 90-R (Derogatis, 1992; German version:Franke, 2002) is a self-report inventory which measures psycho-logical symptoms with a time reference of 1 week. The instrumentconsists of 90 items. Participants rate each item on a scale of 1(no problem) to 5 (very serious). The questionnaire yields scoreson nine specific dimensions and three global scores; however, in astudy with a large, representative German sample, the postulatednine-factor structure could not be replicated (Hessel, Schumacher,Geyer, & Brahler, 2001). Instead, one global factor seems to existwhich indicates general symptom stress and which is best repre-sented by the global scores (Global Severity Index, Positive Symp-tom Total, and Positive Symptom Distress Index). Of these, wewill exclusively refer to the Global Severity Index (GSI), as thereis a clinically relevant cutoff score available for this index (GSI ≥.77; Franke, 2002).

BDI. The BDI (Beck & Steer, 1987; Beck, Steer, & Garbin, 1988;German version: Hautzinger et al., 1995) aims at measuring theseverity of depression in adults and serves as an indicator of generalpsychological functioning and well-being. The widely used self-report questionnaire consists of 21 groups of items and yields onesum score. Participants are asked to choose the one item of a groupwhich describes best how they have felt during the last 7 days.



Items have been selected following DSM-IV diagnostic criteriafor major depression. Reliability and validity of the instrumenthave been proven in numerous studies (Richter, Werner, Heerlein,Kraus, & Sauer, 1998).

Definition of the symptom-triad criterion. On the basis of the mea-sures used in this study, the criteria of the symptom triad weredefined as follows:

• Presence of at least one regulatory symptom in the child(sleeping or feeding problem, excessive crying, or agitation).

• Disordered or disturbed relationship between parent andchild, defined as PIR-GAS score of 60 or below.

• Severe psychological distress or hints of psychopathologyin the primary caregiver, expressed by an SCL-90-R GlobalSeverity Index of at least .77.

RESULTS

Regulatory Symptoms and Diagnoses

Frequency of regulatory symptoms . Overall, 67 (41.4%) of thereferred children presented at least one regulatory symptom. Ofthose, 28 showed two symptoms, and 6 children showed threesymptoms. In 95 children (58.6%), no symptoms of a regula-

tory disorder were reported. Boys and girls did not differ intheir overall chance to exhibit symptoms of a regulatory disorder,χ2 = .039, n.s. In the following, the data of boys and girls wereanalyzed together.

Age. Table 4 enlists the frequency of regulatory symptoms accord-ing to age groups. Although regulatory symptoms were present ina substantial proportion of children from those children who were4.0 to 5.9 (28.4%) years of age, they occurred more frequently inthe group of children who were 1.5 to 3.9 (63.3%) years old. Thedifference between groups was significant, χ2 = 18.97, p < .000;therefore, the following analyses were conducted separately forboth age groups.

Association with Behavior Problems

Children with regulatory symptoms were compared to childrenwith other symptoms with respect to their scores on the CBCL/1.5–5 scales. The multivariate analysis of variance (ANOVA), F(10,69) = 2.90, p = .004, takes the number of comparisons over allscales into account and demonstrates statistically overall significantdifferences. In detail, children with regulatory symptoms scoredmarginally higher on the Somatic Complaints scale (M = 60.20,SD = 8.62) than did children without regulatory symptoms (M =55.31, SD = 6.08), F(1, 77) = 8.39, p = .005 (see Table 5). On the

TABLE 4. Number and Percentage of Regulatory Symptoms in Children from Different Age Groups

Excessive Crying Feeding/Eating Sleeping Symptoms Agitation At Least One Regulatory Symptoma

Age Group n n n n n %

1.5–3.9 years (n = 60) 4 19 23 17 38 63.34.0–5.9 years (n = 102) 8 9 20 7 29 28.4Total (N = 162) 12 28 43 24 67 41.4

aPercentages do not add up to 100 because some children showed more than one symptom.

TABLE 5. Post Hoc Test of Differences Between Children With Regulatory Symptoms Compared to Children Without Regulatory Symptoms inT-Scores (M and SD) from a Significant MANOVA Test (see text)

Regulatory Symptoms No Regulatory Symptoms(n = 25) (n = 54)

M SD M SD F(1, 77) p

Emotional Problems 62.96 10.37 63.91 8.78 0.18 .675Anxious/Depressed 59.72 10.83 59.31 8.81 0.03 .860Somatic Complaints 60.20 8.62 55.31 6.08 8.39 .005Withdrawn 56.88 6.00 62.98 11.33 6.39 .014Attention Problems 64.28 8.63 62.72 8.86 3.02 .086Aggressive Behavior 64.76 8.13 64.04 10.22 0.54 .466Sleep Problems 62.08 11.61 57.87 9.20 0.10 .757Internalizing Problems 60.76 9.64 62.02 8.00 0.37 .544Externalizing Problems 64.68 8.17 63.20 10.51 0.38 .537Total Problems 63.72 8.61 63.30 8.06 0.05 .832



TABLE 6. Results of the Parent–Infant Global Assessment Scale (PIR-GAS; Aoki, Zeanah, Heller, & Bakshi, 2002) Rating of Relationship Quality(n = 112)

Regulatory Symptoms Other Symptoms Total Sample

Rating Categorya n % n % n %

90–70 Adapted 2 4.5 0 0 3 2.760–40 Disturbed 24 54.5 24 35.3 48 42.930–10 Disordered 18 40.9 43 63.2 61 54.5

44 100 68 100 112 100

aAccording to von Hofacker et al. (1998).

other hand, children with regulatory symptoms scored significantlylower on the Withdrawn scale (M = 56.88, SD = 6.00) than didchildren without regulatory symptoms (M = 62.98, SD = 11.33),F(1, 77) = 6.39, p = .014.

Regulatory Symptoms and Parent-Child Relationship

Quantitative ratings of relationship quality (PIR-GAS) were con-ducted in 112 dyads to yield a dimensional assessment of rela-tionship problems (Table 6). Overall, children with and withoutregulatory symptoms did not differ significantly in their PIR-GASscore. In children without regulatory symptoms, mean PIR-GASscore was 34.3 (SD = 12.1), and in children with one or moreregulatory symptoms, the mean score was 36.4 (SD = 13.8). Aunivariate ANOVA yielded no significant effect of symptoms, F(1,108) = .229, n.s., age group, F(1, 108) = .012, or Age Group ×Symptoms interaction, F(1, 108) = 1.79, n.s.

Parental Mental Health

Questionnaire results indicated that parents of children with reg-ulatory symptoms differed from parents of children without regu-latory symptoms with respect to mental health. On the SCL 90-R,parents of children with regulatory symptoms scored higher on theGSI (.93, SD = .53) than did parents of children without regulatorysymptoms (GSI = .66, SD = .44). Parents of children with regu-latory symptoms also scored higher on the BDI than did parentsof children with other symptoms (M = 16.18, SD = 8.85 vs. M =13.32, SD = 8.73, respectively). In a multivariate ANOVA, therewas a significant effect of symptoms, F(2, 60) = 3.54, p < .035,no significant effect of age group, F(1, 61) = 1.52, n.s., and no sig-nificant Symptoms × Age Group interaction, F(1, 61) = 1.66, n.s.Specifically, with regard to the SCL-GSI score as the dependentvariable, there was a significant between-subjects effect of symp-toms, F(1, 61) = 5.40, p < .023, while there was no significanteffect with regard to BDI sum scores, F(1, 61) = .71, n.s.

Prevalence of the Symptom Triad

Of the 67 children with at least one regulatory symptom, 11 (15.4%)fulfilled the criteria of the symptom triad. Thus, in relation to thetotal sample of 162 children under 6 years of age, there were 6.8%

children with a regulatory disorder according to the criterion ofthe symptom triad. Of these, 3 were girls, and 8 were boys. Sixchildren were from the group of children who were 1.5 to 3.9(18–47 months) years old, and 5 were from the group of childrenwho were 4.0 to 5.9 (48–71 months) old. The mean age of thesechildren was 3.8 years (SD = 1.3).

DISCUSSION

In this article, we have compared young children with symptoms ofa regulatory disorder (excessive crying, sleeping problems, feedingproblems, agitation) to young children with other psychiatric symp-toms (e.g., behavior or emotional problems) who were successivelyreferred for treatment to the Family Day Hospital, Munster. Groupswere examined on the basis of clinical data collected over a 10-yearperiod.

Epidemiologic Results

Regulatory symptoms were detected in 63.3% of the 1.5- to 3-year-old children and in 28.4% of 4- and 5-year-old children. Of the 67children total with any regulatory symptoms, n = 11 (16.4%) ful-filled all three criteria of the symptom triad, which qualifies themfor a full regulatory disorder according to the German guidelines.In relation to the total sample of 162 referred children, this ac-counted for 6.8% of the sample. In contrast, Mothander and Moe(2008), who applied the DC: 0–3 system to examine the prevalenceof regulatory, feeding, and sleeping disorders in a clinical sampleof 138 children, obtained a prevalence of 26% (19% regulatorydisorders, 4% sleep disorders, and 3% eating disorders). This dis-crepancy suggests that the symptom-triad criterion is stricter thanis the DC: 0–3 criteria.

Second, our results imply that regulatory symptoms such assleeping or feeding/eating problems, agitation, and even excessivecrying are not confined to infant and toddler age but still may bepresent in preschool children up to 5 years of age. Although thefrequency of these symptoms decreased with age in our study,there still was a substantial proportion of 4- and 5-year-olds in thisclinical sample who exhibited regulatory symptoms, and 5 of themeven fulfilled all three criteria of a full regulatory disorder. This



result is in line with research that has showed that in a considerableproportion of children with regulatory symptoms in infancy, similaror closely related symptoms still may occur at 3 to 8 years of age(Canivet, et al., 2000, 2004; Desantis et al., 2004).

Behavioral Symptoms

With regard to behavioral symptoms, as assessed by the CBCL/1.5–5, we found that children with regulatory symptoms tended toscore higher on the Somatic Complaints scale and lower on theWithdrawn scale than did children with other psychiatric symp-toms (see Table 4). Interestingly, Cesari et al. (2003) found a verysimilar pattern when comparing a group of toddlers with regula-tory disorders to a group of toddlers with developmental disorders(each according to DC: 0–3 criteria). In the group of childrenwith regulatory disorders, they observed higher scores on the So-matic Complaints scale and lower scores on Withdrawn scale thanwas observed in the group of children with developmental disor-ders. Children with regulatory symptoms probably score higher onthe Somatic Complaints scale than do other children because oftheir basic physiological immaturity, which affects their organiza-tion of behavior as well as their physical functioning (De Gangiet al., 1991; Greenspan, 1997). The differences on the Withdrawnscale are more difficult to explain. Possibly, children with regu-latory difficulties are particularly vigilant and highly interested inchanges in their environment, which may protect them from de-veloping the social–relational disturbances which are depicted inthe Withdrawn scale. This clinically relevant issue warrants furtherresearch.

Relationship Disorders

We have compared the degree of relationship disorders in chil-dren with and without regulatory symptoms on the basis of thequantitative PIR-GAS relationship rating (according to DC: 0–3).We did not find any significant differences between the groups.Instead, according to PIR-GAS criteria, the relationships betweenalmost all children and their parents in this sample were eitherdisordered (54.4%) or disturbed to a certain degree (additional42.9%) while only 2.7% of all dyads were rated as “adapted.” Notethat Mothander and Moe (2008), the authors of the Scandinavianoutpatient clinic study (discussed earlier), came to very similar re-sults. In this study of children with a wide range of symptoms, 48%of the parent–child dyads were classified as having a relationshipdisorder, and additional 40% were classified as being at risk ofdeveloping a relationship disorder.

Taken together, these findings may indicate that relationshipdisorders are not a specific and defining component of regulatorydisorders but rather a very frequent context condition of mentalhealth problems in young children. This association may be ex-plained by a variety of reasons. First, a disturbed parent–childrelationship may cause or contribute to the development of regula-tory or other psychiatric symptoms in the child (Muris, Meesters,& van den Berg, 2003; Roelofs, Meesters, ter Huurne, Bamelis,

& Muris, 2006). Second, these adversarial processes often willbe reciprocal, such that symptoms in the child affect the rela-tionship between parent and child (Collins, Maccoby, Steinberg,Hetherington, & Bornstein, 2000; Lifford, Harold, & Thapar,2008). Third, relationship disturbances and psychiatric symptomsin early childhood may have a common cause, such as psychiatricillness in a parent (Hall, 1996) or severe parenting stress (Deater-Deckard, 2004).

In summary, relationship disorders do not seem to be a spe-cific characteristic of regulatory disorders. Instead, they may beunderstood as a general correlating or contributing factor in childpsychiatry. However, this does not mean that relationship disorderswere not important in diagnosing a regulatory disorder. Rather,the presence of a relationship disorder may be considered as oneof several criteria which are mandatory for diagnosing a distinctregulatory disorder (German Society of Child and Adolescent Psy-chiatry, Psychosomatics and Psychotherapy, 2007).

Parental Mental Health

Next, we dealt with the mental health in parents of children with andwithout regulatory symptoms. Parents of children with regulatorysymptoms scored significantly higher on the GSI of the SCL 90-Rthan did parents of children with other symptoms, and they showeda tendency to score higher on the BDI. These findings indicatethat parents of children with regulatory symptoms suffer from anextraordinarily high symptom burden. This supports the notionthat regulatory disorders involve severe parental distress (GermanSociety of Child and Adolescent Psychiatry, Psychosomatics andPsychotherapy, 2007). To address the reasons for the high level ofdistress in parents of children with regulatory symptoms, furtherresearch will be required.

Limitations

There are some limitations to the present study. The sample wassmall and, as a clinical sample from only one hospital, quite spe-cific. However, as several findings were consistent with the inter-national literature, the generalization of results to other clinicalsamples of the same age may be acceptable.

Second, our sample included children between 1.5 and 5 years,an age range that is beyond what is usually proposed for regulatorydisorders (0–3 years). Yet, in our sample, we actually observedregulatory symptoms in 4- and 5-year-old children. However, it isnot clear if these symptoms can be considered as “regulatory symp-toms” or if they should be interpreted as symptoms of a differentdisorder. Great effort is required on conceptual clarity of regulatoryterms (see Table 1) to allow a fruitful discussion among researchers,along with an explicit methodology on how to measure these terms.Such definitions of regulation or regulatory disorder should be pre-cise enough to distinguish between different concepts, but be opento an ongoing development and improvement of alternative mea-sures. The lack of an adequate disorder definition coupled with thecomplex methodology which requires the involvement of multiplesources of information including parents, preschool settings, and



other caregivers, and multiple methods including interview, obser-vation, video recording, biological markers, and other sources, havemade such studies very difficult to date (Carter, Briggs-Gowan, &Davis, 2004; Skovgaard, Houmann, Landorph, & Christiansen,2004). Given these prerequisites, further studies could aim at ex-amining the type, frequency, and meaning of regulatory symptomsin older preschool children. For example, our study consideredonly diagnoses of regulatory disorders according to the symptom-triad criterion. To directly compare regulatory disorders detectedon the basis of the symptom triad with diagnoses on the basis ofthe DC: 0–3R, a different study design including both forms ofdiagnostic in one sample would be preferable. This design couldnot be realized in this study because of clinical constraints; yet, itwould be an important desideratum for future research.

Furthermore, there was no one developmental measure avail-able for the total age range which could yield comparable resultsin motor, language, or other learning deficits. Such a single devel-opmental measure could be useful to identify incipient secondarydeficits. Further refinements on empirical data are related to lon-gitudinal community studies to advance our knowledge of earlyregulatory disorders. Well-operationalized diagnostic criteria witha specification of age at onset, severity, and duration of symp-toms and higher rates of evidence-based data are required. For thedevelopment of sensitive diagnostic criteria, epidemiological datafrom representative population studies are needed; these are as yetunavailable (Carter et al., 2004). Verifying the hypothetical con-tinuity or progression over time of, for instance, early regulatorydisorders to attention deficit hyperactivity disorder is a challengingresearch task.

CLINICAL IMPLICATIONS

In early childhood, basic ability to regulate behavior and emo-tions develops in multiple functional systems. Early and severedysfunction in underlying developmental processes such as affectregulation, inhibitory control, or behavior regulation is likely toimpact sleeping, feeding, and sensory reactivity, predisposing forrelational disturbances and a range of child psychiatric symptomsacross diverse contexts (Egger & Angold, 2006). Clinical symp-toms in regulatory disorder therefore range from hypersensitiv-ity, impulsivity, irritability, and hyper- or hypoactivity supposedlyleading to sleep and feeding behavior disorders. In our study, thesesymptoms were associated with and may progress to withdrawnbehavior and increased somatic complaints scores as measured bythe CBCL 1.5–5, such as aches (Item 1), nausea (Item 45), stomachaches (Item 78), and vomits (Item 93).

Our finding that regulatory symptoms also a re documentedin older preschool children (see Table 4) might be important in thecontext of child psychiatric diagnosis, counseling, and treatment.Child psychiatry should address regulatory symptoms with specificinterventions not only in infants and toddlers but also in olderpreschool children.

Our results have shown that relationship disorders were notmore common among children with regulatory symptoms than they

were among children with other psychiatric symptoms, as virtuallyall of the parent–child relationships in this clinical sample showedmore or less severe disturbances. Nevertheless, the improvementof the parent–child relationship may play a critical role in thetreatment of regulatory symptoms in young children (Cohen et al.,2002; Cohen et al., 1999; Lojkasek, Cohen, & Muir, 1994). Anappropriate treatment setting adapted to this goal may be offeredby Family Day Hospitals or Units, as they regularly admit and treatchild and parent together. This also is important when consideringparental mental health. In our study, parents of children with regu-latory symptoms exhibited even more psychological distress thandid parents of children with other symptoms. Therefore, specifictreatment for those parents will be necessary, which also can easilybe implemented in the setting of a Family Day Hospital.

In an effort to guide clinical practice and to stimulate furthersystematic clinical research, the definition of regulatory disorder asoffered by the guidelines covers a wide range of early child psychi-atric clinical symptoms. Its face validity was derived from clinicalconsensus and expertise without substantial empirical proof. It of-fers a good usefulness in terms of acting as a starting point forclinical practice and training, and as a hypothesis-generating basisfor subsequent systematic research. Clinical expertise and empiri-cal evidence are equally important in medicine and correspond tothe underlying evaluation of its main focus: medicine as primarilya pragmatic clinical practice or medicine as primarily research-oriented empirical science, respectively. The development of anempirically sound diagnostic classification system depends on bothaspects. It is achievable only if the process of clinical observationfollowed by hypothesis creation and hypothesis testing by meansof evidence-based research data is repeated in a continuous cycleof model and data interpretation until valid and reliable classifica-tions are achieved (Postert et al., 2009). A transactional definitionof regulatory disorder is an unusual hypothesis that has proved to beuseful in clinical practice, difficult to validate in empirical researchdue to basic methodological reasons, conceptually provoking in itstransgression of individual disorder entity, and stimulating for fur-ther research that is urgently needed in this evolving field of earlypreschool psychiatry.

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