open access protocol an exploratory trial implementing ... · lisa gibbs,1 elizabeth waters,1...

An exploratory trial implementinga community-based child oral healthpromotion intervention for Australianfamilies from refugee and migrantbackgrounds: a protocol paper forTeeth Tales

Lisa Gibbs,1 Elizabeth Waters,1 Andrea de Silva,1,2 Elisha Riggs,1,3

Laurence Moore,4 Christine Armit,5 Britt Johnson,1 Michal Morris,6 Hanny Calache,2

Mark Gussy,7 Dana Young,1 Maryanne Tadic,5 Bradley Christian,1 Iqbal Gondal,8

Richard Watt,9 Veronika Pradel,5 Mandy Truong,1 Lisa Gold10

To cite: Gibbs L, Waters E,de Silva A, et al. Anexploratory trial implementinga community-based child oralhealth promotion interventionfor Australian families fromrefugee and migrantbackgrounds: a protocolpaper for Teeth Tales. BMJOpen 2014;4:e004260.doi:10.1136/bmjopen-2013-004260

▸ Prepublication history forthis paper is available online.To view these files pleasevisit the journal online(http://dx.doi.org/10.1136/bmjopen-2013-004260).

Received 16 October 2013Revised 7 February 2014Accepted 10 February 2014

For numbered affiliations seeend of article.

Correspondence toAssociate Professor Lisa Gibbs;[email protected]

ABSTRACTIntroduction: Inequalities are evident in earlychildhood caries rates with the socially disadvantagedexperiencing greater burden of disease. This studybuilds on formative qualitative research, conducted inthe Moreland/Hume local government areas ofMelbourne, Victoria 2006–2009, in response tocommunity concerns for oral health of children fromrefugee and migrant backgrounds. Development of thecommunity-based intervention described here extendsthe partnership approach to cogeneration ofcontemporary evidence with continued and meaningfulinvolvement of investigators, community, cultural andgovernment partners. This trial aims to establish amodel for child oral health promotion for culturallydiverse communities in Australia.Methods and analysis: This is an exploratory trialimplementing a community-based child oral healthpromotion intervention for Australian families fromrefugee and migrant backgrounds. Families from an Iraqi,Lebanese or Pakistani background with children aged 1–4 years, residing in metropolitan Melbourne, were invitedto participate in the trial by peer educators from theirrespective communities using snowball and purposivesampling techniques. Target sample size was 600.Moreland, a culturally diverse, inner-urban metropolitanarea of Melbourne, was chosen as the intervention site.The intervention comprised peer educator led communityoral health education sessions and reorienting of dentalhealth and family services through cultural CompetencyOrganisational Review (CORe).Ethics and dissemination: Ethics approval for thistrial was granted by the University of Melbourne HumanResearch Ethics Committee and the Department ofEducation and Early Childhood Development ResearchCommittee. Study progress and output will bedisseminated via periodic newsletters, peer-reviewedresearch papers, reports, community seminars and atNational and International conferences.

Trial registration number: Australian New ZealandClinical Trials Registry (ACTRN12611000532909).

BACKGROUNDEarly childhood caries (ECC) is a particularlyaggressive form of the disease and is charac-terised by rampant decay in the teeth ofinfants and young children. In 2006, 41% ofAustralian 4-year-olds had dental caries, withtwo teeth per child, on average, having cariesto the point of cavitation (dmft=1.94).1 ECCleft untreated can lead to pain, infection,

Strengths and limitations of this study

▪ A culturally competent community-basedparticipatory research process adopted to helpbuild a relationship of trust and partnershipbetween the researchers and communitiesinvolved and to maximise the acceptability of theprogramme and the uptake of research findings.

▪ Study design and methods developed from initialcommunity research and then piloted in a similarcommunity context.

▪ Study design adapted to ensure relevance andapplicability to cultural networks and servicedelivery considerations.

▪ Use of peer educators to increase the culturalappropriateness and accessibility of theintervention.

▪ Non-random allocation of participants to theintervention introduces a potential source ofbias.

Gibbs L, Waters E, de Silva A, et al. BMJ Open 2014;4:e004260. doi:10.1136/bmjopen-2013-004260 1

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abscesses and hospitalisation.2 Recent Australian dataindicate that among preschool children, dental caries isthe primary cause of hospitalisation for oral healthcare.3

Adverse effects of dental caries include: poor self-imageand self-esteem, reduced social interaction, problems indeveloping permanent dentition and chronic stress anddepression.4 ECC can also impair the quality of life ofchildren by interfering with vital functions of daily livingsuch as food selection, eating, swallowing, speaking andsocial interactions, as well as incurring great financialcost.4 5

Social inequalities are evident in ECC rates with thesocially and economically disadvantaged having the greaterburden of disease.6 7 A recent report on the oral health ofAustralian children aged 2–3 years indicated that those chil-dren experiencing social disadvantage were 3.29 timesmore likely to have an oral health problem compared tothe least disadvantaged children.8 This highlights ECC as apotential risk for children from refugee and migrant back-grounds as their families are documented, in most cases, tobe more socially disadvantaged and have poorer oral healthcompared to the parent population of the country theymigrate to, assuming migration is to a more developedcountry.9–11 Such a scenario has been observed in Australiaamong children who are non-English speaking refugees.12

In Victoria, refugee and asylum seekers are considered apriority group and publically funded dental services aremade more accessible to these communities by reducingcosts and wait times. However, many of these communitiesstill do not access services.This paper presents the study protocol for the third

phase of Teeth Tales, an exploratory trial implementinga community-based child oral health promotion inter-vention for Australian families from refugee andmigrant backgrounds. The trial builds on the formativequalitative research conducted in the first phase ofTeeth Tales from 2006 to 2009 in response to commu-nity concerns for the oral health of children fromrefugee and migrant backgrounds residing in theMoreland and Hume local government areas (LGAs) ofMelbourne (figure 1). The qualitative research involvedpeople from Iraqi, Lebanese and Pakistani communities,identified as migrant and refugee groups with a highrepresentation of young families in the LGA ofMoreland, an urban area of Melbourne, Australia.13

They also represent a mix of migration histories andtime since arrival including predominantly humanitar-ian and family reconnection migration (Lebanese—first,second and third generation and Iraqi—first and secondgeneration) versus skilled migration (Pakistani—firstgeneration). This formative research was undertaken bythe University of Melbourne and Merri CommunityHealth Services in partnership with Dental HealthServices Victoria (DHSV), Arabic Welfare, VictorianArabic Social Services and representatives of thePakistani community, and Moreland City Council.Community leaders, parents, grandparents and repre-sentatives from cultural organisations representing the

Iraqi, Lebanese and Pakistani communities, participatedin a series of semistructured focus groups and interviewsto explore the social, cultural and environmental influ-ences of poor child oral health in these communities.The findings identified cultural impacts on oral healthbeliefs, behaviours and knowledge such as avoidance oftap water due to experience of unsafe drinking water inhome countries, lack of knowledge of water fluoridation;and frequent consumption of high sugar, high fat foodsand drinks which were considered ‘luxury items’ in theirhomeland and therefore were not a regular part of thediet. Use of traditional oral health practices includingthe miswak chewing stick by the Muslim community wasfound to be a common practice to prevent poor dentalhealth14; but miswak use did not begin until childrenstarted school meaning there was little or no oralhygiene in the preschool years. In Victoria, early oralhealth prevention, support and treatment programmesand services are available such as, The Smiles4Miles pro-gramme, an oral health promotion programme foryoung children. However, this programme was not reach-ing the targeted communities because of their lowinvolvement in the preschool settings where the pro-gramme is delivered. Similarly, the Early Childhood OralHealth Program is a dental care programme availablefor children which was not being utilised by the targetcommunities because of significant barriers to accessingdental services and experiences of discrimination, high-lighting the need for culturally appropriate services.There was strong interest in support for child oralhealth expressed by the participating communities.A need for parenting support was also identified due tothe social isolation of many mothers of young chil-dren.15 The piloting of this study, conducted in thesecond phase of Teeth Tales, also highlighted the criticalimportance of working collaboratively and flexibly withcommunity-based cultural organisations in order toengage meaningfully with migrant families.16

Results from this formative qualitative and pilot researchinformed the development of a community-based inter-vention through a collaborative process with investigators,community, cultural and government partners. The inter-vention framework was designed to be multisite and multi-level consistent with the Fisher-Owens Model andinformed by the limited evidence of effective oral healthpromotion community-based interventions.17–24

Phase 3 of Teeth Tales is an exploratory trial implementingthe community based child oral health promotion interven-tion for Australian families from refugee and migrant back-grounds. See table 1 for the trial aims and objectives.

METHODSStudy designPhase 3 of Teeth Tales is an exploratory trial implementinga community-based child oral health promotion interven-tion for Australian families from refugee and migrantbackgrounds. The intervention includes peer educator led

2 Gibbs L, Waters E, de Silva A, et al. BMJ Open 2014;4:e004260. doi:10.1136/bmjopen-2013-004260

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community oral health education sessions and a reorient-ing of dental health and family services through a CulturalCompetency Organisational Review (CORe; see below).The planned intervention trial was piloted at NorthRichmond Community Health (NRCH) in 2010–2011.This led to several changes being made to the originalstudy design.16

Study locationLGAs in Australia are the third and lowest tier of govern-ment, administered by State and Territory governments.Moreland LGA in Melbourne, Victoria was chosen as theintervention site for this study as it was the location ofthe earlier formative qualitative study. Moreland is a cul-turally diverse, inner-urban metropolitan LGA ofMelbourne, Australia. Moreland has one of the mostdiverse populations in Melbourne with just overone-third of residents born overseas and approximately40% speaking a language other than English at home.25

Theoretical frameworks and principlesThe theoretical framework underpinning the overallapproach is the socioenvironmental model of health26

which recognises the range of interacting socioculturaland environmental influences on health beliefs andbehaviours. This framework was applied within this trialthrough use of the Fisher-Owens et al24 conceptualmodel of interacting biological, child-level, family-leveland community-level influences on child oral health

over time. The model guided the development of arange of community-based intervention strategiesdesigned to achieve positive oral health knowledge,behaviour and environmental change outcomes. Thecultural competence framework for systems and pro-grammes27–31 provided guidance for conductingresearch focusing on sociocultural differences in cultur-ally diverse community contexts. Cultural competence isdefined as ‘a set of congruent behaviours, attitudes andpolicies that come together in a system, agency oramong professionals and enable that system, agency orthose professions to work effectively in cross-culturalsituations’.31 32 It is strongly aligned with community-based participatory research (CBPR) which is an orienta-tion to research which focuses on the relationshipbetween research partners and is one that involves anequitable partnership between researchers andmembers of the community.33–36

The peer education component of the intervention isinformed by social learning theory in which peoplelearn by observing and modelling the social behavioursof others with whom the person identifies, and throughtraining in skills that lead to confidence in being able tocarry out behaviours.37

Recruitment—peer educatorsBilingual peer educators were identified and recruited intothe trial by community and cultural partners based ontheir communication and leadership skills and cultural

Figure 1 Teeth tales phases.


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Table 1 Trial aims, objectives and measures

Aim: Establish a model for feasible, replicable and affordable child oral health promotion for culturally diverse LGAsin Australia

Objectives—assessment of effectiveness Measures1a. Assess the impact of the intervention on frequency ofchild tooth brushing

Child dental examination▸ Debris index (plaque status)▸ Modified gingival index (gingival health)Parent Questionnaire▸ How often are the child’s teeth/mouth cleaned?

1b. Assess the impact of the intervention on parent’sknowledge of child oral hygiene needs

Parent questionnaire▸ In your opinion, when should parents first start cleaning their

child’s teeth?▸ Has anyone ever shown you how to clean/brush this child’s

teeth/mouth?▸ Fluoride in drinking water helps prevent tooth decay.▸ If my child has a problem with his/her teeth I know what todo.

▸ Do you think using a bottle in bed causes tooth decay inchildren?

Objectives—process evaluation2a. Determine the costs of the intervention Measured by records of resources invested in the intervention

by participating organisations2b. Identify facilitators and barriers to implementing bothcomponents of the intervention

Project documentation, formal reflexive practice discussionsand observation activities, and focus group discussions withcultural partner organisationsCORe staff survey

2c. Assess intervention, fidelity, dose and reach Project documentation, focus groups and interviews,researcher observationsCORe staff survey and document review

Objectives—descriptive analyses3a. Measure change in child oral health over time for targetcultural groups

Child dental examination▸ ICDAS II (dental caries status)▸ Care index (calculated at analysis not in examination and is

the proportion of decayed, missing and filled teeth (dmft)that have been treated restoratively)

Parent questionnaireHow would you rate the oral health of this child?

3b. Measure change in child and parent oral health-relatedbehaviours over time for target cultural groups

Parent questionnaire▸ In a usual week, how often does your child have the

following drink (multiple options provided)In a usual week, how often does your child have the followingfoods: (multiple options provided)Do you add sugar or sweet flavourings to your child’s (a) foodand (b) drinks?▸ Who usually cleans/brushes this child’s teeth/mouth?▸ What do you use to clean your child’s teeth/mouth?▸ What type of toothpaste do you usually use to brush thischild’s teeth?

3c. Measure change in parent/care-giver oral health-relatedknowledge, confidence and attitudes over time for targetcultural groups

Parent Questionnaire▸ How confident do you feel cleaning this child’s teeth?▸ I can look after my child’s oral health well▸ I can easily get good advice about my child’s oral health if I

need to▸ Do you think any of the following cause tooth decay in

children? (multiple options provided)▸ In your opinion, when should parents first start cleaning their

child’s teeth? (multiple options provided)4a. Assess access to dental and other services over timefor target cultural groups

MCHS service use reportsParent questionnaire▸ Has your child ever visited a dentist?

Continued


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affinity with the targeted cultural groups. These peereducators were trained by Teeth Tales staff to assist withfamily recruitment and data collection, and to coordin-ate and conduct the community oral health educationsessions. Reimbursement was provided for peer educatorattendance at the peer educator training course, forassistance at recruitment sessions and for conductingthe oral health community education sessions. Peer edu-cators in some cases were employed as casual staff specif-ically for the role and in others selected from existingstaff within the partner cultural organisations. The TeethTales budget also included appropriate remunerationfor the role of the cultural organisations in supportingthe intervention and research components of the trial.

Recruitment—trial participantsFamilies from an Iraqi, Lebanese or Pakistani backgroundwith children aged 1–4 years and residing in metropol-itan Melbourne were invited to participate in the studyby peer educators from their respective communitiesusing snowball and purposive sampling techniques. Thisnon-probability sampling technique is useful in reachingsocially isolated populations.38 Participants wererecruited by peer educators through cultural networks,community centres, schools, kindergartens, maternaland child health clinics, playgroups and other relevantsettings. Potential participants were given dates and loca-tions for the recruitment session and invited to attend.

Baseline data collection also took place at recruitmentsessions. Recruitment into the trial entailed writtenparent/care-giver consent for self and children.All staff from organisations (ie, Merri Community

Health Services, Moreland City Council and theUniversity of Melbourne research centre) participatingin CORe (further details about CORe provided below)were invited via an email, from the Chief ExecutiveOfficer, to complete a staff survey and reminded to par-ticipate through staff meetings and reminder emails toincrease response rate. The online and hard copy ver-sions of the survey were available to accommodate staffpreferences. Key informants from each organisationwere also asked to assist with the CORe documentreview. Organisations then nominate their own group ofmanagers and staff to take responsibility for the develop-ment and implementation of the CORe action plan.

InterventionThe Teeth Tales intervention aims to prevent early child-hood child dental caries and promote positive oralhealth behaviour among migrant and refugee childrenaged 1–4 years and their parents/care-givers inMoreland, Victoria, Australia (see box 1).The intervention will achieve this through implemen-

tation of two intervention components: (1) a peereducator-led community oral health education pro-gramme and (2) a cultural competence organisationalreview (see figure 2). Details of each intervention com-ponent are provided below.

Community oral health educationThe community oral health education programme wasunderpinned by the employment of cultural peer educa-tors and conducted in culturally appropriate and access-ible community settings. A two stage model of peereducation was applied in Teeth Tales.39 The first stageinvolved training people who are members of a commu-nity (in this case determined by language spoken, ethni-city and cultural affinity) in the topic of choice (in thiscase oral health). The second stage was application ofinformation about the topic to educate people in theirown community, via either informal or formal informa-tion sessions with methods depending on the goals of

Box 1 Intervention aims and objectives

Specific aims1. Achieve substantive and sustained improvements in oral

health and healthy behaviours of children and parents ofmigrant and refugee background.

2. Reduce the strong social gradient evident in child oral health.Intervention objectives1a. Improve child oral health.1b. Improve child and parent/care-giver oral health-related

behaviours.1c. Improve parent/care-giver oral health-related knowledge, confi-

dence and attitudes.2a. Increase access to dental and other family services.2b. Improve cultural competency of local health and dental

services.

Table 1 Continued

Aim: Establish a model for feasible, replicable and affordable child oral health promotion for culturally diverse LGAsin Australia

▸ Where was your child’s last dental visit?▸ How long since you last saw a dentist?▸ Where was your last dental visit?

4b. Assess change in cultural competency of local healthand dental services over time

Measured by CORe follow-up staff survey and documentreview

CORe, Cultural Competency Organisational Review; ICDAS, International Caries Detection and Assessment System; LGA, local governmentarea; MCHS, Merri Community Health Services.


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the project and the context of the target group (in thiscase via community oral health education sessions).Peer educators were trained by Teeth Tales staff in a

series of sessions (5 h/week for 4 weeks) to deliver com-munity oral health education sessions for their respect-ive communities in a culturally appropriate setting. Thetopics covered in the training were based on evidenceinformed key oral health messages of Eat Well, DrinkWell, Clean Well and Stay Well and informed by thephase 1 findings from Teeth Tales. The training alsoincluded a dental clinic visit at the community healthservice, a teeth cleaning demonstration and practice,practice in the use of plaque disclosing agents, as wellas an introduction to other family services provided byMerri Community Health Services and Moreland CityCouncil. During the interactive peer educator training,

their cultural expertise was sought to make any finaladjustments to the content and delivery of the commu-nity education sessions to suit particular culturalgroups. This was incorporated into the opportunitiesduring training for the peer educators to develop andpractice their skills. A refresher course was provided forpeer educators if there was a 6-month gap or more oftime between training and the planned start of commu-nity education sessions. Further support was provided tothe peer educators through the provision of a trainingmanual, resources and reading material. Teeth Talesstaff were available to support the peer educators in theorganisation and delivery of training sessions asneeded.The community education sessions for parents/care-

givers (see below) were conducted by the trained peer

Figure 2 Logic model.


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educators and included two 3 h sessions of oral healtheducation followed by a site visit hosted by the commu-nity health dental service and including local councilstaff. The two oral health education sessions were con-ducted either on the same day or on different days, tosuit the participants. The site visit was conducted a weekafter the last education session. Participants began thecourse with an introduction to dental services inVictoria, Australia, the structure of teeth, dental cariesand what causes decay, and a discussion about their ownoral health beliefs, values and practices and strategiesfor managing change. The topic areas of Eat Well andDrink Well, adapted from the DHSV Smiles 4 Miles pro-gramme (http://www.dhsv.org.au/smiles4miles/),focused on promoting healthy food and drink consump-tion, suitable foods for children, the benefits of fluori-dated water consumption, limiting high sugar foods anddrinks in the diet and linking these behaviours to toothdecay. Clean Well focused on the benefit of fluoridatedtoothpaste to prevent tooth decay, correct tooth brush-ing techniques, and promoted brushing teeth twice aday. Participants were provided with family oral healthpacks that included toothbrushes and toothpastes pro-vided free for family members. Participants (parents/caregivers) were given an opportunity to practice brush-ing their own teeth using plaque disclosing agents toidentify areas of plaque stagnation. This was intended tohelp them to identify how to improve their brushingeffectiveness. Stay Well promotes the benefits of regularvisits to the dentist and included a group visit to MerriCommunity Health Services to increase familiarity withthe site, the staff, appointment booking processes, thefee structure and the dental clinic experience.Participants joined in a teeth cleaning demonstration,and were introduced to a range of family services pro-vided by the health service and local government.Reminders of the key oral health messages were sent bypeer educators to community education participants atregular intervals following completion of the pro-gramme (one message per month for 4 months). Thelanguage of the reminder messages and method ofdelivery were determined by participant preference fortext message, email, phone call or mailed reminders.

Cultural Competence Organisational ReviewCORe provided an opportunity for organisations toconduct a guided evidence-informed internal review ofcultural competence in terms of staff perceptions oforganisational practice and documented policies andsystems. The CORe staff survey, implementation guideand results report were organised according to the fol-lowing six domains identified as critical for organisa-tional cultural competence: governance; planning,monitoring and evaluation; communication; staff devel-opment; partnerships and services and interventions.40

The results of the baseline CORe assessment, describedbelow under data collection and data analysis, wereprovided to the respective organisations, with resources

and templates providing best practice examples, to helpdirect their action planning process. This was directedby a working group, including senior staff, within theorganisation. Partner organisation, Centre for Culture,Ethnicity and Health (CEH) supported organisationsparticipating in CORe as this is consistent with theirstandard services.

Allocation to intervention—peer education programmeCommunity participants were recruited to the interven-tion arm if their residential address was within Morelandor any adjacent LGAs, to ensure they had access to thepeer educator led community oral health education ses-sions and the Merri Community Health Services andMoreland City Council services introduced as part of theCORe intervention programme. Families from outsidethese areas were treated as the comparison group(figure 3).

Statistical powerThe purpose of an exploratory trial is to assess the feasi-bility, relevance and affordability of the interventionrather than testing for significant change. However,given the target sample size of 600 was relatively largefor an exploratory trial, we anticipated sufficient powerto detect significant differences in relation to childtooth brushing, assessed by the frequency of toothbrushing and modified gingival index as a proximal indi-cator. The formative qualitative research in the firstphase of Teeth Tales identified that parents did not con-sider the first dentition as requiring care because theyfall out and are replaced. Therefore, the clean wellmessage was considered likely to have the greatestimpact, requiring fairly simple behaviour change.Assuming a sample size of 600 families (300 per arm),allowing for a 20% dropout, a two tailed α of 0.05 andno clustering effects, there is 95% power to detect a25% change in tooth brushing frequency. This is consist-ent with the level of change seen in other oral healthpromotion intervention studies.20 41 We also anticipatedthat it would be possible to detect a difference in parentknowledge of child oral hygiene needs, with similarpower calculations. While we acknowledge the potentialfor clustering effects by peer educator/practitioner, wedid not include this in our power estimation as the smallnumber of practitioners/peer educators per culturalgroup (from as low as 1 per cultural group) means thatthe practitioner effect cannot be estimated independ-ently of the intervention effect. We attempted to minim-ise this practitioner clustering effect by havingstandardised information resources as well as peer edu-cator training across the three different cultural groups.

Data collectionAll of the following measures were scheduled to beconducted at baseline (from March to September 2012)and at 18 months of follow-up (from September 2013 toMarch 2014).


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All children aged 1–4 years at baseline in the participat-ing families received dental examinations carried out bytrained dental professionals to assess their oral healthstatus, using a protocol successfully applied in previousoral health studies conducted by the investigators.42 Thedental examinations were held in community locationsand took place immediately following recruitment. Theexaminations, conducted by one examiner and one

recorder, assessed evidence of ECC, presence of plaqueand gingival health as risk indicators for oral health and asan indicator of effective oral hygiene and combined,objective indicators of tooth brushing. The child wasexamined in a lap-to-lap position with their legs wrappedaround their mother’s (or primary carer) lap and withtheir head resting on the examiner’s lap. Teeth and sur-faces were examined in a standard order; from the upper

Figure 3 Flow of participants through the trial.


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right quadrant to the upper left quadrant and the lowerleft quadrant to the lower right quadrant, examining thesurfaces in order, that is, distal, occlusal, mesial, buccaland lingual. The Federation Dentaire Internationale(FDI) two-digit tooth numbering system (ie, 11, 21, 55, 54,53, etc) was employed. Dental caries were diagnosed andscored using codes of the International Caries Detectionand Assessment System—ICDAS II,43 however, tooth sur-faces were not dried using compressed air. Hence, ourswill be a modified version of the ICDAS II. Cotton woolwas used to clean the tooth surfaces. Plaque status wasmeasured using the debris index and gingival health mea-sured using the Modified Gingival Index.44 All examina-tions were carried out by visual inspection only, using aheadlamp and disposable dental mirrors. Dental probeswere not used and dental radiographs not taken.Structured self-administered parent questionnaires were

used to collect data on: sociodemographic-economicstatus; child feeding habits; child and parents/caregivers’oral hygiene-related behaviour; self-reported oral andgeneral health status for children and parent/care-giver;parent/care-giver’s knowledge and attitudes about oralhealth and towards local dental health services; and confi-dence and capacity to implement positive oral health prac-tices. However, translated questionnaires were available inArabic and Urdu, it was recognised that some participantsfrom these communities may have low literacy and needassistance. Peer educators explained the project toparents/care-givers, provided verbal translations of thequestionnaire and assisted parents/care-givers with ques-tionnaire completion when needed/requested.The CORe staff survey consisted mainly of multiple-

choice questions to assess staff perceptions of organisa-tional cultural competence practices under the six culturalcompetency domains—governance; planning, monitoringand evaluation; communication; staff development; part-nerships; and services and interventions. All participatingorganisations are multisite and multisetting so the surveyasked staff to respond based on their own work site. TheCORe document review will be conducted by a seniormanager and a representative from CEH, to assess docu-mentary evidence of cultural competence in relation toexisting organisational policies and systems.Process data will be collected through partner meetings

and organisational documentation to monitor if the inter-vention is being implemented as intended, includingfocus group discussions at the end of the interventionperiod with peer educators and cultural organisation part-ners to review intervention processes, facilitators and bar-riers. Economic data will be collected through the parentquestionnaires and through meetings with partner organi-sations to monitor resource use and assess cost implica-tions of the Teeth Tales intervention for participatingfamilies and organisations. In addition, the economic ana-lysis will be informed by records of resources used toimplement the education sessions and CORe processes.The alignment of the trial objectives, outcomes and

measures are presented in table 1.

Data qualityTraining and calibration of dental examiners in the useof the diagnostic protocol was conducted centrally andsupervised by experienced investigators. This process wasrepeated annually. For quality assurance purposesapproximately 5% of the sample will be re-examined.Data recorders were trained in data entry protocols. Datacleaning and management will be conducted by anexperienced Research Fellow under direction of experi-enced investigators. Cross-training of partners will occurthroughout: research staff were trained in culturally com-petent public health research methods; staff from the cul-tural and community partner organisations were alsotrained in relevant research methods. Location-basedallocation of participants to intervention and comparisongroups will potentially compromise the blinding of thedental examiners and researchers to the interventionstatus of the participants. Hence, the data managementand analysis were designed to minimise this bias byemploying controls such as, the researcher analysing thedata will not perform electronic data entry, trial partici-pants were allocated ID numbers by external personnel,and the data analysis plan developed a priori.Participant information sheets and questionnaires

were translated into the respective community languagesand support provided by bilingual peer educators toensure that the participants were able to make aninformed decision regarding trial participation and ableto clearly understand the questionnaire.CORe was also conducted at the research centre

leading the study, McCaughey Centre for CommunityWellbeing, Melbourne School of Population and GlobalHealth, University of Melbourne, to contribute toprocess evaluation, capacity building, cultural compe-tence and to demonstrate commitment to the projectaims and outcomes.

Data analysisDescriptive analyses will first be conducted to illustrateparticipant characteristics stratified by cultural group.Design-weighted survey estimators will be used whererequired.The Outcome data will be analysed using bivariable and

multivariable analyses. Estimates and CIs for outcomeswill be computed and compared across the interventionand comparison groups at baseline and follow-up. Thedifference in estimates between groups will be tested forsignificance for the primary outcomes. Subgroup ana-lyses will be conducted for ethnicity, time in Australia,and socioeconomic status, in recognition of the poten-tial influence of ethnicity and acculturation as well asdemographic factors on outcomes.Process data will be critically reviewed throughout the

trial to identify any barriers and facilitators to change,and inform modifications in trial methods and processesto maintain study integrity and research rigour.Descriptive statistics of peer educator activity and inter-vention participation will also be generated to provide


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important information about intervention reach anddose. The qualitative components will adhere to theRATS guidelines on qualitative research (http://www.biomedcentral.com/ifora/rats).Economic data on resources used will be analysed to

assess costs of the intervention and to compare thesecosts with the outcomes achieved. Measured resourceuse will be valued (in 2012 Australian dollars) usingstandard unit cost data sources (eg, salary scales, RACVtravel cost estimates).CORe staff survey data—cross-sectional data will be

analysed using descriptive statistics to describe partici-pant characteristics and provide frequency distributionsto each question. A score for the organisation across allrespondents and responses will be derived in total foreach domain score. Comparisons between predictor andoutcome variables will be made using χ2 tests of associa-tions. Logistic and multinomial regressions will also beconducted where appropriate. Differences in organisa-tional scores will be compared between baseline andfollow-up.CORe document review data will be reviewed by expert

staff from CEH to determine the extent to which organi-sations’ documented policies and procedures meet theCORe cultural competency guidelines within the follow-ing domains: governance; planning, monitoring andevaluation; communication; staff development; partner-ships and services and interventions. A level of culturalcompetence will be assigned by the CEH staff memberto the organisation for each domain, using the categor-ies defined by Cross et al31—cultural destructiveness, cul-tural incapacity, cultural blindness, culturalprecompetence, cultural competence and culturalproficiency.Parallel data collection and analysis of each measure

will be conducted to preserve methodological rigour.A mixed method analysis of findings will then be con-ducted to provide a more comprehensive understandingof trial impacts and outcomes.45

DISCUSSIONThe importance of the interacting influences of environ-mental, sociocultural and personal influences on individ-ual health behaviours and population health outcomes iscentral to accepted socioenvironmental theoretical fra-meworks26 46 including the Fisher-Owens et al24 concep-tual model of influences on children’s oral health andthe Ottawa Charter for Health Promotion47 which out-lines the need for action at multiple levels. This guidesthe development of interventions by showing the import-ance of achieving a shift in environments and healthbehaviours to achieve health outcomes. To be sustain-able, interventions need to be embedded into relevantsystems and processes, and population-level interventionsalso need to include strategies to engage vulnerablegroups within the population to ensure that there is noincrease in health inequalities.48 Therefore, interventions

addressing the needs of potentially vulnerable popula-tions should be used as a complement to populationapproaches.Teeth Tales is a multilevel community-based interven-

tion informed by previous research that identified thesociocultural and environmental influences on childoral health in migrant and refugee communities in theMoreland LGA. The culturally competent, participatoryprocesses adopted in phase 1 of Teeth Tales greatlyenhanced the research process and the resultant find-ings. Therefore the study continued this approach intothe trial phase of Teeth Tales. A CBPR process helpsbuild a relationship of trust and partnership betweenthe researcher and the communities being researched,and has been shown to be effective in reaching sociallyisolated communities; recruiting and sustaining largenumbers of community participants in the researchprocess; and engaging communities to adopt and sustainhealthy practices.36 CBPR is defined as a collaborativeapproach to research that equitably involves all partnersin the research process and recognises the uniquestrengths that each brings. CBPR begins with a researchtopic of importance to the community with the aim ofcombining knowledge and action for social change toimprove community health and eliminate health dispar-ities.36 As communities are directly involved there aremore chances that positive outcomes will be sustainableand the empowered communities will take the initiativeto push for policy and practice change to improve theircircumstances.36 49 A culturally competent approachaccounts for the added complexity of conducting CBPRin a culturally diverse setting.28 Accordingly in this study,there is a commitment at all stages of the research todevelop and maintain an active partnership with com-munity and cultural partners recognising the expertiseof (1) community and government partners (communityhealth including public dental services, local govern-ment and state government agency) in relation to thecommunity context, service systems, policy and servicedelivery methods and options and (2) the expertise ofcultural partners in relation to cultural beliefs, practicesand concerns, information pathways and methods ofengagement. This shared responsibility and decision-making is reflected in the costaffing arrangements forthe study with funded Teeth Tales staff being employedby four of the partner organisations—University ofMelbourne, Merri Community Health Services, ArabicWelfare and Victorian Arabic Social Services. Partnerorganisations, including Pakistan Australia AssociationMelbourne, also provide expert advice throughout devel-opment and implementation of the trial and practicalassistance to the research process by embedding theresearch trial within their service delivery systems anddisseminating research information. The capacity ofcommunity organisations as change advocates is high-lighted by this approach and provides opportunities forall partner organisations to extend the trial benefitsthrough ongoing application of the shared new


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knowledge as well as extension of the skills gained to col-laboratively address other community-based health/social issues.The piloting of the intervention trial in phase 2 of

Teeth Tales further demonstrated the importance oftaking a participatory approach in complex and multidi-mensional public health interventions in order to estab-lish feasibility, effective implementation and relevance tothe community and cultural context in which the inter-vention will operate. While there was considerablesupport for the pilot in North Richmond from localagencies, there was very limited involvement from cul-tural organisations either because of their limitedresources or because they did not yet exist for new andemerging cultural groups being targeted. This meantregular adjustments to research processes to accommo-date the complex nature of community-based servicedelivery, and the importance of stakeholder engagementthroughout the entire process to provide advice on com-munity and cultural considerations. In doing so itdemonstrated the critical importance of the ongoingcultural partnerships operating in the communitycontext and the importance of these relationships forsuccess in reaching the target communities. Despitethese learnings and the expressed need for child oralhealth support by the Moreland-based communitygroups and cultural organisations in the formative quali-tative phase of Teeth Tales, recruitment of families tothe intervention trial was still challenging. This reflectsthe reality of community-based research and the com-peting demands of family life that may make attendanceat research and health promoting events a low priorityunless they are linked to services or events families arealready attending.Social learning theory as a foundation for peer educa-

tion relies strongly on role modelling, practising oflearned behaviours and positive reinforcement.37 InTeeth Tales the peer educators model healthy eating anddrinking through choice of refreshments provided incourses, teeth cleaning demonstrations, and reports oftheir own family changes in child eating and drinkingbehaviours. While there are various models of peer edu-cation, a key feature is seen to be the credibility of theperson and the peer education model.39 In some cases,an informal approach by a peer can be more effective inreaching disengaged groups, while other groups preferhealth education to come from ‘experts’ rather thanpeers. The Teeth Tales model addresses both of thesescenarios by using cultural peers in informal settings butwith a structured programme and the formal backingand training of key cultural, health and academic organi-sations. This has the advantage of increasing the likeli-hood of sustainability of the programme throughongoing opportunities for the partner organisations toutilise their trained staff and resources. However, it is alsopossible that this ‘blurring’ of distinction between expertand peer advice could reduce the impact of the peer edu-cation model.

It is necessary to find a balance when designing andimplementing community-based intervention studies toaddress the demands of research rigour and requirementsfor strength of evidence, while still operating within exist-ing systems and community processes. For example, themodifications to the trial design arising from the pilotphase meant that instead of nominating an interventionand a comparison community, we would instead have adefined intervention site and a broad recruitment catch-ment area with allocation to intervention and comparisongroups determined by the residential address of the par-ticipant. This modification to trial design means that it wasnot possible to randomly allocate participants to the inter-vention, introducing a potential source of bias in our trial.However, it was agreed that being rigid in terms of studydesign would have reduced the relevance and applicabilityof the intervention.

ConclusionTeeth Tales will provide an opportunity to addressinequities in child oral health through the trial of acommunity-based child oral health promotion interven-tion trial targeted specifically for migrant and refugeecommunities in the Moreland area of Melbourne. Thetrial will inform policy and practice decision-making byparticipating partners in relation to cultural competenceimprovements. The trial findings will contribute to thelimited evidence base relating to community interventionsto improve child oral health in migrant communities. Ifthe results from this trial are promising it will lead to thedevelopment of a model for a community-based child oralhealth intervention which would ideally be tested using amultisite cluster randomised controlled trial to informpolicy and practice more widely. It is also expected thatthe outcomes from this exploratory trial will raise mean-ingful questions and pave the way for further research inrelation to oral health inequities for migrant communities.

Author affiliations1Jack Brockhoff Child Health and Wellbeing Program, Melbourne School ofPopulation and Global Health, University of Melbourne, Carlton, Victoria,Australia2Dental Health Services Victoria, Carlton, Victoria, Australia3Healthy Mothers Healthy Families Research Group, Murdoch Children’sResearch Institute, Parkville, Victoria, Australia4MRC/CSO Social and Public Health Sciences Unit, University of Glasgow,Glasgow, Scotland5Merri Community Health Services, Brunswick, Victoria, Australia6Centre for Culture, Ethnicity and Health, Richmond, Victoria, Australia7Department of Dentistry and Oral Health, La Trobe Rural Health School,La Trobe University, Bendigo, Victoria, Australia8Faculty of Information Technology, Monash University and Pakistan AustraliaAssociation Melbourne, Caulfield, Victoria, Australia9Epidemiology and Public Health, University College London, London, UK10Deakin Health Economics, Deakin University, Burwood, Victoria, Australia

Acknowledgements The authors would like to dedicate this paper in memoryof Coralie Mathews, a much loved member of the Teeth Tales team and theheart and soul of the Teeth Tales project. The authors wish to thank researchparticipants who were willing to participate in the trial, the peer educatorswho have shown considerable skill and commitment to the trial, and the


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many cultural, community and government organisations who have supportedits development and implementation. In particular, they wish to acknowledgeour colleagues and representatives from partner organisations on the TeethTales study who chose not to be authors on this paper but have contributedconceptually and in practical terms to the trial—Arabic Welfare, VictorianArabic Social Services, North Richmond Community Health, Moreland CityCouncil and Yarra City Council. The authors wish to gratefully acknowledgethe Jack Brockhoff Foundation for infrastructure.

Contributors LGibbs was principal investigator of the study and drafted thepaper. All of the coauthors contributed to the study design and to the completionof the manuscript. Specifically, EW contributed to the cross-disciplinaryapproach and evidence base contributions. AdS contributed to the data analysisconsiderations. ER contributed to ethnicity and oral health evidence. LMcontributed to the study design and statistical analysis. CA contributed to servicedelivery considerations. BJ contributed to piloting and development of studymethods. MM contributed to the development of cultural competence measures.HC contributed to dental procedures and policy. MG contributed to thedevelopment of oral health measures and methods. DY contributed tocommunity partnerships, intervention and data collection components. MTcontributed to community health policy considerations. BC contributed to thedata collection and data management. IG contributed to the cultural influencesand networks. RW contributed to the international evidence. VP contributed tore-orientation of services components. MT contributed to the measurement ofcultural competence. LGold contributed to economic analysis. All authors readand approved the final manuscript.

Funding This project was funded by an Australian Research Council Linkagegrant (LP100100223), with cash and in-kind contributions from Linkagepartners—Merri Community Health Services, Dental Health Services Victoria,Moreland City Council, Victorian Arabic Social Services, Arabic Welfare andPakistan Australia Association Melbourne. Additional funding support wasalso provided by Merri Community Health Services. Separate funding grantscontributing to the overall research activities were also received from DentalHealth Services Victoria and Moreland City Council. The authors wish to thankColgate-Palmolive Australia for donating the toothbrushes and toothpasteswhich were included in gift bags for the intervention participants.

Competing interests Consistent with the participatory approach of this study,many of the study authors (AdS, CA, MM, HC, DY, MT, IG) representedorganisations, as listed in their affiliations, that have an interest in or areinvolved in the delivery of the services described in the intervention. Salarysupport for EW, LGibbs and AdS from Jack Brockhoff Foundation, and theAustralian National Health and Medical Research Council for salary supportfor LGold, and La Trobe University for salary support for MG. MT is a gratefulrecipient of an Australian Postgraduate Award PhD scholarship. ER issupported by the Murdoch Childrens Research Institute which is supported bythe Victorian Government’s Operational Infrastructure Support Program.

Ethics approval Ethics approval for this trial was granted by the University ofMelbourne Human Research Ethics Committee and the Department ofEducation and Early Childhood Development Research Committee.

Provenance and peer review Not commissioned; externally peer reviewed.

Open Access This is an Open Access article distributed in accordance withthe Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license,which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, providedthe original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

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