full report: antenatal parenting support: an exploratory randomised contol trail of psychosocial

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Social adversity and poor maternal mental health during pregnancy have long-term adverse effects on children’s health, social, educational and economic outcomes. Depression, anxiety and stress in pregnancy may have direct physiological effects on the fetus as well as impairing development of maternal sensitivity to the child. There is a need for improved antenatal support and more effective engagement with ‘high risk’ mothers-to-be.

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  • SCPHRP

    Final report

    form for SCPHRP grants

    SCPHRP reference number: SCPH/13

    Please complete this form in Verdana 10 point font size

    Project title:

    Antenatal parenting support: an exploratory randomised controlled trial of psychosocial antenatal programmes.

    Start date: January 2012 Finish date: June 2013

    Investigators:

    Philip Wilson Angus MacBeth

    Christine Puckering Sharon McAlees

    Lucy Thompson Marion Henderson

    Anne Clarke 1. SUMMARY

    Social adversity and poor maternal mental health during pregnancy have long-term adverse effects on childrens health, social, educational and economic outcomes. Depression, anxiety and stress in pregnancy may have direct physiological effects on the fetus as well as impairing development of maternal sensitivity to the child. There is a need for improved antenatal support and more effective engagement with high risk mothers-to-be.

    Consecutive women meeting high risk criteria were invited to participate in trial. Participants (n=35) were randomly allocated in clusters of six, to either a Mellow Bumps group, an active comparison group (Chill-out in Pregnancy) or care-as-usual. Mellow Bumps is a six-week group based antenatal parenting programme which aims to decrease maternal antenatal stress levels and emphasise the importance of early interaction in enhancing brain development and attachment. Chill-out in Pregnancy is a six-week group based stress reduction programme.

    Results suggest that taking part in either a Mellow Bumps group or Chill-out in Pregnancy may contribute to modest improvements in mental health and wellbeing when measured eight to twelve weeks post-birth compared to care-as-usual.

    2. ORIGINAL AIMS The original aim of this study was to compare the impact of participation in a Mellow Bumps intervention with that of a control intervention, as well as care-as-usual, on the mental health of pregnant women with additional health and social care needs.

    3. METHODOLOGY 3.1. Study Design

    This was an exploratory study for a three-arm parallel randomised open-label blinded end- point (PROBE) clinical trial design. Referrals to specialist midwifery services of women in Inverclyde and Ayrshire meeting the Special Needs in Pregnancy (SNiP) criteria used in NHS Greater Glasgow and Clyde were invited to participate. SNiP protocols are largely based on

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  • maternal and family factors, so can be readily detected early in pregnancy, making early intervention feasible. It includes women who have previous or current mental health issues, substance misuse, have had previous children who are looked after or accommodated in local authority or kinship care or are involved in the criminal justice system (see appendix 1). These women may have had previous negative experiences with health and/or social services. Consented participants were randomly allocated, in groups of six, to either Mellow Bumps, an active comparison condition Chill-out in Pregnancy, or Care-as-usual. Participants were offered a 20 shopping voucher at the last data collection point.

    3.2. Interventions: The two active interventions were offered in addition to participants routine maternity care (Care-as-usual).

    Mellow Bumps (MB)

    MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers understanding of neonates capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks gestation, to capture the period when the risk of miscarriage is low and fetal movement felt, but before major preoccupation with the delivery.

    Chill-out in Pregnancy (ChIP) CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. Like MB, it runs for six weeks at two hours per week. It aims to decrease maternal stress levels.

    Care-as-usual (CAU) Participants in NHS Greater Glasgow & Clyde received care in line with local Special Needs in Pregnancy protocol. Participants in NHS Ayrshire & Arran received care in line with local Vulnerable Families guidelines. If indicated, a pre-birth case conference was arranged, between weeks 28-32 of the pregnancy, which was followed by either a child protection case conference post-birth or a post-birth planning meeting when necessary.

    3.3. Outcome measures Information from participants was collected at three collection time points: pre-intervention (majority within two weeks of the intervention starting), post-intervention (majority within two weeks of the intervention finishing) and 8-12 weeks post-birth. Apart from the infant saliva samples, which community midwives were asked to collect on the fifth postnatal day, the measures were administered face-to-face by the researcher in the participants home.

    Pre-intervention The Adult Wellbeing scale (AWS): generates scores in four domains depression, anxiety, outward-directed irritability and inward-directed irritability. The dimensions have different cut- off scores that indicate a possible problem in that area (Table 1).

    Edinburgh Postnatal Depression Scale (EPDS): generates a single score. The cut-off points that suggest that a woman may have depression are detailed in Table 1.

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  • Domain Normal score Borderline score

    Probable problem score

    AWS-depression 0-3 4-6 7-15 AWS-anxiety 0-5 6-8 9-15 AWS-outward irritability 0-4 5-7 8-12 AWS-inward irritability 0-3 4-6 7-12 EPDS 0-9 10-12 13-30

    Table 1: Cut-off scores Participants were also asked to provide saliva samples, by drooling or spitting into provided receptacles, for cortisol assays. Samples were to be collected on three occasions each day repeated on two days:

    (i) Time 1: on waking in the morning

    (ii) Time 2: 45 minutes after time 1

    (iii)Time 3: when retiring to bed for the night Post-intervention

    AWS, EPDS, saliva samples for cortisol assays

    5 days post-birth

    Saliva samples from infant pre- and post-new born heelprick blood sampling (Guthrie test) for cortisol assays.

    8-12 weeks post-birth AWS, EPDS, saliva samples for cortisol assays, mother-baby video, semi-structured interview.

    3.4. Ethics

    The study was reviewed and approved by the NHS West of Scotland Research Ethics Committee (12/WS/0024, 4th April 2012).

    3.5. Trial Registration

    This trial is registered with ClinicalTrials.gov (ID NCT01590212).

    4. RESULTS

    4.1. Recruitment

    Pregnant women who met the inclusion criteria were approached by community midwives in one area in NHS Greater Glasgow & Clyde and in NHS Ayrshire & Arran. If potential participants were agreeable their details were passed on to the researcher who arranged to visit them at home to discuss the project further. Originally, it was planned to run two MB groups, two CHiP groups and two CAU groups; one of each in each area with eight women in each group, n=48. Recruitment was slower than anticipated for a number of reasons:

    (i) The period available for recruitment was substantially shortened because of a prolonged dispute between Disclosure Scotland and NHS R&D: Disclosure Scotland would only provide Basic Disclosure whereas NHS R&D required Enhanced Disclosure for access to the sites. Ultimately the researchers Enhanced Disclosure for another post was accepted by NHS R&D as valid evidence.

    (ii) The rate of referral was slower than hoped. As a consequence, the target geographic area in NHS Ayrshire & Arran was extended.

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  • Eventually, 35 women were recruited to the project. In order to ensure that there were sufficient women at the right stage of pregnancy to make running a group intervention viable, participants were randomly allocated in groups of six to MB, CHiP or CAU. For the final group, randomisation was abandoned to ensure that two CHiP groups would run. Of 31 participants who completed the questionnaires at baseline, 68% (n=21) completed the information at all three time points. Of the remainder two participants completed baseline and post-intervention questionnaires and two completed baseline and 8-12 weeks post-birth measures (see Figure 1: Participant flow diagram. From consent to the final data collection point, 23 participants were retained in the project for between 19 and 34 weeks (mean 27.13, SD 4.495).

    Referred n=50

    Declined n=11 Failed contact n=4

    Recruited n=35

    Withdrew n=2

    Failed contact n=2

    Baseline data n=31

    Post-intervention data

    Withdrew n=2 No contact on advice of health

    professional n=1 Failed contact n=5

    Contact attempted including failed contacts at post-intervention

    Failed contact n=2 Withdrew n=2

    No contact on advice of health professional n=1

    8-12 week post-birth data n=23

    Figure 1: Participant flow diagram

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  • Num

    ber

    4.2. Participants

    14

    12

    10

    8

    6

    4

    2

    0 19 years or 20-24 years 25-29 years 30-34 years 35-39 years 40+ years

    less Age group

    Figure 2: Participant age groups Age: Participants were aged between 17 and 42 years (mean 27.14, SD 7.49), see Figure 2.

    Parity: 29% (n=10) participants were first time parents, 51% (n=18) had one or two children and 20% (n=7) had three or more children. Of those who had children, six (24%) had children who were being looked after by the local authority or in kinship care.

    Social circumstances: 66% (n=23) participants lived in an area that was measured, by the Scottish Index of Multiple Deprivation (SIMD), as one of the 20% most deprived areas. 26% (n=9) lived in the second most deprived quintile. The remainder (8%, n=3) lived in the second least deprived area quintile.

    Primary referral criteria: The majority of participants had mental health issues (48%, n=17) or there were child protection concerns (23%, n=8), see Figure 3.

    Even though this was the participants primary referral criterion, many had complex issues. For example, one had previous child protection concerns as well as a history of substance misuse and involvement with the criminal justice system.

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  • Nu

    mb

    er

    18

    16

    14

    12

    10

    8

    6

    4

    2

    0 Mental

    Child

    Criminal

    Substance

    Care leaver Domestic

    Young

    health issue protection concerns

    justice (self or partner)

    misuse abuse person complex

    Primary SNiP criteria

    Figure 3: Primary SNiP criteria Infants: Gender (n=23): 11 boys, 12 girls

    Gestation (n=27): 34-41 weeks (mean 39.30, SD 1.81)

    Birth weight (n=23): 2.21-4.41kg (mean 3.39, SD 0.57)

    Group differences at baseline

    There were no statistically significant differences between the groups at baseline in the geographical area deprivation of their home address (2=2.026, df 4, p0.731), age group (2=6.808, df 10, p=0.743), or primary reason (2=10.73, df 12, p=0.552) for referral to the project (Table 2). Similar comparisons were made between those completing baseline data only and those who were followed up. No significant differences were found (see appendix 2).

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  • Group allocation Total

    Mellow Bumps

    CHiP

    Care-as- usual

    SIMD Quintile 1 = most deprived, 5 = least deprived

    1 N %

    8 5 7 20 80.0% 55.6% 58.3% 64.5%

    2 N %

    1 3 4 8 10.0% 33.3% 33.3% 25.8%

    4 N %

    1 1 1 3 10.0% 11.1% 8.3% 9.7%

    Age groups 19 years or less N %

    1 1 1 3 10.0% 11.1% 8.3% 9.7%

    20-24 years N %

    4 3 4 11 40.0% 33.3% 33.3% 35.5%

    25-29 years N %

    3 1 2 6 30.0% 11.1% 16.7% 19.4%

    30-34 years N %

    2 1 1 4 20.0% 11.1% 8.3% 12.9%

    35-39 years N %

    0 1 3 4 0% 11.1% 25.0% 12.9%

    40+ years N %

    0 2 1 3 0% 22.2% 8.3% 9.7%

    Primary SNiP criteria

    Mental health N issue %

    5 4 7 16 50.0% 44.4% 58.3% 51.6%

    Child protection N concerns %

    2 3 2 7 20.0% 33.3% 16.7% 22.6%

    criminal justice N self or partner %

    1 1 1 3 10.0% 11.1% 8.3% 9.7%

    substance misuse N %

    2 0 0 2 20.0% 0% 0% 6.5%

    care leaver N %

    0 1 0 1 0% 11.1% 0% 3.2%

    domestic abuse N %

    0 0 1 1 0% 0% 8.3% 3.2%

    young person N complex %

    0 0 1 1 0% 0% 8.3% 3.2%

    Total N 10 9 12 31

    Table 2: Geographic deprivation, age groups and primary SNiP criteria by group allocation Analysis by independent samples t-test suggested that there was no statistical significant difference between the mean age of the participants in each group and the length of time they were retained in the project (see appendix 2). However, participants who were allocated to a MB group seemed more likely to be a first time parent compared to those allocated to CHiP or CAU (Table 3).

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  • Group allocation Total

    Mellow Bumps

    CHiP

    Care-as- usual

    First time parent Count % within Group allocation

    4 2 2 8 40.0% 22.2% 16.7% 25.8%

    Experienced parent Count % within Group allocation

    6 7 10 23 60.0% 77.8% 83.3% 74.2%

    Total Count 10 9 12 31

    Table 3: First-time parent by group allocation Also, those allocated to an intervention group were more likely to have had a previous child in local authority or kinship care (2 5.087, df 2, p

  • Figure 4: Baseline measures likely problems Change over time

    Figure 5: EPDS scores by group allocation

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  • Figure 6: AWS-depression scores by group allocation

    Figure 7: AWS-anxiety scores by group allocation

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  • Figure 8: AWS-outward irritability scores by group allocation

    Figure 9: AWS-inward irritability scores by group allocation

    In Figure 5 -Figure 9, it appears that participants in the intervention groups showed improvements in the EPDS and some of the AWS subscale scores that were not replicated in the CAU group (see also appendix 2). In order to adjust for the effect of pre-intervention scores, which appeared to differ between the groups although this was not statistically

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  • significant, an analysis of covariance (ANCOVA) was undertaken. No statistically significant differences (p 0.05) between the groups were found when post-intervention scores and scores at 8-12 weeks post-birth were compared to pre-intervention scores (see appendix 2).

    Cortisol Assays Maternal The saliva samples were unpopular with participants. Feedback suggested that they suspected that the samples might be tested for illicit drugs. As a result, only twelve participants supplied saliva samples at baseline.

    Figure 10: Mean cortisol level pre-intervention The number of saliva samples provided by participants declined at each data collection point; five participants supplied samples post-intervention and only four at the 8-12 week post-birth data collection point (see appendix 2 for descriptive data). The small sample numbers meant that it was not possible to analyse any potential differences in cortisol levels between the groups.

    Infant Samples of saliva were received from seven infants (a total of 14 samples); it was possible to conduct cortisol assays on six. Only two infants had samples with sufficient saliva at both collection points (pre-and post-Guthrie tests. Feedback from community midwives suggested that collecting the saliva by the laboratorys preferred method (small plastic pipette) had been extremely difficult and seemed to distress the infants. The lack of samples precluded further data analysis.

    N

    Minimum

    Maximum

    Mean

    Std. Deviation

    Baby pre-Guthrie cortisol (nmol/l)) baby post-Gurthrie cortisol (nmol/l))

    3 3

    2 2

    54 18

    23.33 9.67

    27.227 8.021

    Table 6: Baby cortisol assays

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  • Mother-baby interaction video Eighteen participants agreed to the researcher filming them whilst they cared for their infant, for example, during feeding or nappy changing. The videos were examined using the Mellow Parenting Observation System (MPOS). Low positive and high negative rates are indicative of possible problems in the relationship1,2. No statistically significant differences were found between the groups (see appendix 2).

    MB

    CHiP

    CAU

    -0.1 -0.05 0 0.05 0.1 0.15 0.2 Negative interactions (rate per sec.) Positive interactions (rate per sec.)

    Qualitative feedback

    Figure 11: Mother-infant interactions

    At the 8-12 week post-birth data collection point, participants were asked about their antenatal, delivery and postnatal experiences of support, their experiences of the group intervention if they took part and their feelings about taking part in a research project in semi- structured interview. Interviews were audio-recorded and transcribed verbatim. The transcripts have just been completed. As a result, there was insufficient time to carry out a rigorous thematic analysis for this report. It is planned that this will be carried out in the near future and written up for publication in a peer-reviewed journal.

    Preliminary qualitative analysis suggests that, for the majority of the participants it was an unplanned pregnancy. Participants were concerned about how they would cope. For a few, there was a worry about the reaction of social services,

    I was worried in case I wasnt going to get to keep him because of what happened before (PID 107, MB).

    In general, those that had attended an intervention group viewed the experience positively. Being able to meet other pregnant women in a non-judgemental environment was valued,

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  • the ladies (group facilitators) didnae judgeI thoroughly enjoyed itit was funthe ladies were very supportive and I would highly recommend it (CHiP) (PID 118, CHiP)

    The activities of the groups had provided opportunities to relax as well as learn,

    we done the desert island task thing with the play doughit was calming, it calms you down, it makes you forget about everything else thats all bad, and youre just concentrating on the goodyour minds no thinking about the negatives, youre thinking about the positives and the future, things like that (PID 122, CHiP)

    we were watching the DVD and it was abootyou talking to your child and all

    that, aboot the brain cellsI found that very, very interestingthat amazed me that DVDIm different wi him (this baby) than I was wi the rest of thaimI spend mair time talking to himIve got four kids and it made me sit and thinkI could spend a wee bit extra time wi thaim in the day, its about all those wee extra brain cells (PID 107, MB)

    In addition, for this participant, the CHiP group had provided practical support,

    CHiPs (sic) helped me to get a pram and a car seat and different things that I needed and didnt have the money for (PID 123, CHiP).

    Furthermore, this participant was continuing to use the relaxation techniques that she had learnt in the group to help her cope with everyday situations,

    I panic quite a lot when Im out and now I dont care, Ill stop and Ill breathebreathe the way they taught mejust to calm down (PID 123, CHiP).

    It seems that taking part had had short term benefits as well as potential longer term positive outcomes. As a reflection, perhaps, of the value placed on the group, many of the participants mentioned that they felt that a six week period for the programme was too short.

    5. DISCUSSION The results presented in this report suggest that taking part in either a Mellow Bumps or Chill- out in Pregnancy group had positive effects on the mental health and wellbeing of women who are vulnerable in pregnancy. Previous research has demonstrated that maternal mental health and wellbeing impacts on child development3. In particular, depression impairs maternal sensitivity and atunement to an infants needs with subsequent potential problems with attachment. Insecure attachment is a risk factor for later emotional behaviour problems4. Even though the size of the sample means that the results should be interpreted with a degree of caution, this study suggests that these group programmes were effective in helping women facing social adversity and their infants. No significant inter-group differences were found in analysis of video interactions at 8-12 postnatal weeks, but numbers were small and no baseline video data were available.

    Traditional antenatal education programmes tend to fail to engage with women who face social adversity5. In this study, participants with significant health and social care needs were recruited. Feedback from those that took part in the groups has been positive suggesting that the format of the programmes was acceptable to this population.

    Furthermore, this study has served as a useful exploratory study assessing the feasibility of recruiting to a randomised trial of Mellow Bumps. Many of the lessons have informed the development of the Trial of Healthy Relationships in Very-Early years (THRIVE) project.

    Limitations

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  • The findings of this feasibility study should be considered in the light of the following limitations. Firstly, this study was limited to participants living in one health board area and one community health care partnership (CHCP) in the west of Scotland. It is possible that the working practices of community midwives may have differed from other potential settings. Secondly, all the participants were actively engaged with health services when they were recruited to the study. It was not possible to identify individuals who were reluctant to engage with midwives. Thirdly, the method used to recruit participants may have compromised the dependability of the findings. Midwives were asked to identify individuals and refer them to the project. It is possible that the participants approached were only those that were thought to be likely to take part in the group programmes. Lastly, it is possible that participants answered the questionnaires in a way that they felt would be received positively by either the research team or health and social service professionals.

    Challenges This project faced a number of challenges from the outset. The delay in gaining access to research sites for the reasons outlined in section 4.1 had repercussions for this study as it was time-limited. The time period available for recruitment and follow-up was reduced significantly. The geographical distance between the two research sites meant that having an nhs.net email account was invaluable to enable personal information to be passed securely between the researcher and practitioners. As this is a hard-to-reach population, considerable perseverance was needed to make contact at the different stages of the project. Text messaging was used to confirm, re-arrange and remind participants of researcher appointments.

    6. CONCLUSIONS The aim of this study was to carry out an exploratory randomised controlled trial of a social intervention with a very hard-to-reach population. The results suggest that psychoeducational interventions in pregnancy may benefit women with major psychosocial needs. We have demonstrated that undertaking a randomised trial in this population is feasible.

    7. IMPORTANCE TO POLICY & PRACTICE AND POSSIBLE IMPLEMENTATION Providing group-based parenting support in a format acceptable to pregant women with additional health and social care needs may impact on their mental wellbeing in the short and longer term, but a definitive trial is required.

    8. FUTURE RESEARCH This project has acted as a feasibility study for the THRIVE project which has been funded by the National Institute for Health Research (1.9M) and is hosted by the MRC/CSO Social Public Health Sciences Unit (SPHSU), University of Glasgow.

    9. DISSEMINATION The preliminary results of this study have been presented at conferences such as the Scottish School of Primary Care annual conference in Inverness in April 2013.

    A dissemination event is planned for August 2013 to which stakeholders along with practitioners will be invited.

    The study will be written up for publication in a peer-reviewed journal. 10. RESEARCH WORKERS

    Jane White was employed by the University of Glasgow to work on this project 0.6wte for a period of fifteen months from January 2012. From April 2013, she has been employed by MRC/CSO SPHSU (now University of Glasgow) to work on the THRIVE project. The PI (Dr Marion Henderson) has allowed Jane to complete data collection in conjunction with working on THRIVE.

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  • The Scottish Mental Health Research Network provided research assistant support to help transcribe the qualitative interviews.

    11. ACKNOWLEDGEMENTS

    This project would not have been possible without the help and support of numerous people. We would like to thank:

    The women who have agreed to take part.

    Elaine Moore, Anne Clarke, Karen Bell, Mary Garven, Marion Dodd, Beth Donnelly, Alison Barr, Jean Reid, and the community midwives who have helped to recruit participants, NHS Ayrshire & Arran.

    Anne Jamieson, Catriona McLean, Morag McPhail, Rose Sloan, Joanne McGarry, Karen Smith, Halina McIntyre, NHS Greater Glasgow & Clyde.

    Rosemary Mackenzie, Harriet Waugh and the Mellow Parenting team who trained the

    group facilitators, developed the Chill-out in Pregnancy programme for this study and have provided on-going support.

    Leona Cunningham, Mellow Parenting, who helped with the analysis of the qualitative feedback

    Elsa Ekevall and Kim Jones, University of Glasgow.

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  • Caoimhe Clarke, Cat. Nixon, Shona Shinwell, MRC/CSO SPHSU, University of Glasgow

    The Scottish Collaboration for Public Health Research and Policy who provided the majority of the funding

    12. REFERENCES 1. Wilson, P.; Thompson, L.; Puckering, C.; McConnachie, A.; Holden, C.; Cassidy, C.; Gillberg,

    C. (2010) Parent-child relationships: are health visitors judgements reliable? Community Practitioner 83(5), pp22-5.

    2. Robertson, J.; Puckering, C.; Parkinson, K.; Corlett, L.; Wright, C. (2011) Motherchild feeding interactions in children with and without weight faltering; nested case control study Appetite 56, pp753759.

    3. Clatworthy J (2012) The effectiveness of antenatal interventions to prevent postnatal depression in high risk women. Journal of Affective Disorders 137 (13), pp 2534.

    4. OConnor TG, Heron J, Golding J, Beveridge M, Glover V (2002) Maternal antenatal anxiety and childrens behavioural/emotional problems at 4 years. Report from the Avon Longitudinal Study of Parents and Children. British Journal of Psychiatry 180, pp5028.

    5. Gagnon AJ, Sandall J (2007) Individual or group antenatal education for childbirth or parenthood, or both. Cochrane Database of Systematic Reviews 2007 (3):CD002869

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  • APPENDIX 1: Special Needs in Pregnancy (SNiP) criteria

    Substance misuse in last 12 months Alcohol misuse in the last 12 months Woman and or partner in criminal justice system HIV positive Child protection issues/concerns for this baby or any previous children whether or not

    currently with parent(s) Significant mental health issues such as:

    o Previous history of bipolar disorder, or previous admission to hospital for treatment of mental illness

    o Family member with history of bipolar disorder (mother/father/brother/sister) o Current mental health problem for example depression or anxiety disorder

    Gender based violence Would benefit from social work support Domestic violence with child protection concerns Homeless Living in supported accomodation Young women including those:

    o Linked to leaving care services with complex needs o With identified or potential child protection concerns o Receiving considerable social work support for complex needs o In youth criminal justice system o Pregnancy conceived under difficult circumstances o Living in supported accommodation o Lacking social support from family/socially isolated o Experiencing mental health ill health o Accommodated by local authority o Linked into leaving care services

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  • Those who completed baseline only

    Total

    2 Baseline only

    Two or more times

    age groups 19 years or less 20-24 years 25-29 years 30-34 years 35-39 years 40+ years

    1 2 3

    2 2.955, df 5, p=0.707

    0 11 11 2 3 5 2 3 5 0 4 4 1 2 3

    SIMD Quintile 1 = 1 most deprived, 5 = least deprived 4

    2 19 21 2 5..135, df 2,

    p=0.077 3 4 7 1 2 3

    Parity First time parent Experienced parent

    2 6 8 2 3.296, df 1, p=0.069 4 19 23

    Previous children yes LAAC

    N/A

    1 4 5 2 0.03, df 1, p=0.862

    3 15 18 2 6 8

    Primary SNiP criteria

    Mental health issue Child protection concerns criminal justice self or partner substance misuse care leaver domestic abuse young person complex

    3 13

    16

    2 5.958, df 6, p=0.428

    1 6

    7 0 3

    3 1 1 2 1 0 1 0 1 1 0 1

    1 Total 6 25 31

    APPENDIX 2: Data Tables

    2

    No

    Table 7: Participants who completed baseline questionnaires only compared to others: age group, geographical deprivation, parity, previous children looked after or accommodated,

    primary SNiP referral reason

    N

    Mean Std.

    Deviation Std. Error Mean

    EDPS score pre-intervention Baseline only Two or more times

    6 11.00 4.561 1.862 25 11.24 6.666 1.333

    AWS depression score pre- Baseline only intervention Two or more times

    6 5.50 2.588 1.057 25 5.96 2.541 .508

    AWS anxiety score pre- Baseline only intervention Two or more times

    6 6.00 4.243 1.732 25 5.92 3.785 .757

    AWS outward irritability score Baseline only pre-intervention Two or more times

    6 4.17 2.137 .872 25 3.52 2.616 .523

    AWS inward irritability score pre- Baseline only intervention Two or more times

    6 2.50 1.517 .619 25 2.44 1.917 .383

    Table 8: Participants who completed baseline questionnaires only compared to others: outcome measures

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  • Independent Samples t-Test: Baseline only vs others Levene's

    Test for Equality of Variances

    t-test for Equality of Means

    F

    Sig.

    t

    df

    Sig. (2- tailed)

    Mean Difference

    Std. Error Difference

    95% Confidence

    Interval of the Difference

    Lower Upper EDPS score Equal pre- variances intervention assumed

    Equal variances not assumed

    3.576 .069 -.083 29 .934 -.240 2.888 -6.147 5.667

    -.105 10.848 .918 -.240 2.290 -5.289 4.809

    AWS Equal depression variances score pre- assumed intervention Equal

    variances not assumed

    .023 .880 -.397 29 .694 -.460 1.159 -2.830 1.910

    -.392 7.497 .706 -.460 1.173 -3.196 2.276

    AWS Equal anxiety variances score pre- assumed intervention Equal

    variances not assumed

    .004 .952 .045 29 .964 .080 1.758 -3.516 3.676

    .042 7.039 .967 .080 1.890 -4.385 4.545

    AWS Equal outward variances irritability assumed score pre- Equal intervention variances

    not assumed

    .124 .728 .560 29 .580 .647 1.155 -1.715 3.008

    .636 9.001 .541 .647 1.017 -1.655 2.948

    AWS inward Equal irritability variances score pre- assumed intervention Equal

    variances not assumed

    1.135 .296 .071 29 .944 .060 .843 -1.664 1.784

    .082 9.283 .936 .060 .728 -1.580 1.700

    Table 9: Participants who completed baseline questionnaires only compared to others: outcome measures independent samples t-test

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  • Group allocation

    age at group start date

    Retention - weeks

    Mellow Bumps N Mean Std. Deviation Minimum Maximum

    10 9 25.20 27.56 5.391 3.712

    18 22 34 34

    CHiP N Mean Std. Deviation Minimum Maximum

    9 5 28.89 24.80 8.594 4.764

    17 21 40 30

    Care-as-usual N Mean Std. Deviation Minimum Maximum

    12 9 29.00 28.00 7.851 5.099

    18 19 42 34

    Table 10: Age and retention by group allocation

    Independent Samples Test: MB vs CHiP Levene's Test

    for Equality of Variances

    t-test for Equality of Means

    F

    Sig.

    t

    df

    Sig. (2- tailed)

    Mean Difference

    Std. Error Difference

    95% Confidence Interval of the

    Difference Lower Upper

    age Equal at variances group assumed start Equal date variances

    not assumed

    4.493 .049 -1.134 17 .273 -3.689 3.254 -10.554 3.176

    -1.107 13.199 .288 -3.689 3.334 -10.880 3.502

    Reten Equal tion - variances weeks assumed

    Equal variances not assumed

    1.604 .229 1.207 12 .251 2.756 2.283 -2.218 7.730

    1.118 6.768 .302 2.756 2.464 -3.111 8.623

    Table 11: Independent t-test baseline demographics Mellow Bumps compared to CHiP

    21

  • Independent Samples Test: MB vs CAU Levene's Test

    for Equality of Variances

    t-test for Equality of Means

    F

    Sig.

    t

    df

    Sig. (2- tailed)

    Mean Difference

    Std. Error Difference

    95% Confidence Interval of the

    Difference Lower Upper

    age at Equal group variances start assumed date Equal

    variances not assumed

    2.394 .138 -1.295 20 .210 -3.800 2.935 -9.922 2.322

    -1.340 19.385 .196 -3.800 2.836 -9.728 2.128

    Retenti Equal on - variances weeks assumed

    Equal variances not assumed

    1.615 .222 -.211 16 .835 -.444 2.102 -4.901 4.012

    -.211 14.620 .835 -.444 2.102 -4.936 4.047

    Table 12: Independent t-test baseline demographics Mellow Bumps compared to Care-as- usual

    Independent Samples Test: CHiP vs CAU Levene's Test

    for Equality of Variances

    t-test for Equality of Means

    F

    Sig.

    t

    df

    Sig. (2- tailed)

    Mean Difference

    Std. Error Difference

    95% Confidence

    Interval of the Difference

    Lower Upper age at Equal group variances start assumed date Equal

    variances not assumed

    .240 .630 -.031 19 .976 -.111 3.604 -7.653 7.431

    -.030 16.459 .976 -.111 3.653 -7.837 7.615

    Retenti Equal on - variances weeks assumed

    Equal variances not assumed

    .003 .958 -1.150 12 .273 -3.200 2.783 -9.264 2.864

    -1.174 8.907 .271 -3.200 2.726 -9.376 2.976

    Table 13: Independent t-test baseline demographics CHiP compared to care-as-usual

    22

  • Baseline EDPS score AWS depression

    score

    AWS anxiety score

    AWS outward

    irritability score

    AWS inward irritablity

    score

    Mellow N Bumps Mean

    Minimum Maximum

    Std. Deviation

    10 10 10 10 10 14.10 7.00 6.30 4.80 2.80

    8 4 3 1 0 21 11 11 10 6

    4.358 2.108 2.791 2.821 2.044 CHiP N

    Mean Minimum Maximum

    Std. Deviation

    9 9 9 9 9 11.00 6.00 6.78 3.11 2.33

    0 2 0 1 0 20 10 12 7 5

    6.595 2.550 3.734 2.315 1.732 Care-as- N

    usual Mean Minimum Maximum

    Std. Deviation

    11 11 11 11 11 9.27 5.00 5.36 3.09 2.27

    1 1 0 0 0 20 8 12 6 6

    6.987 2.608 4.653 2.343 1.902 Total N

    Mean Minimum Maximum

    Std. Deviation

    31 31 31 31 31 11.19 5.87 5.94 3.65 2.45

    0 1 0 0 0 21 11 12 10 6

    6.247 2.513 3.803 2.511 1.823

    Table 14: Outcome measures at baseline

    Post-Intervention EPDS score AWS depression

    score

    AWS anxiety score

    AWS outward

    irritability score

    AWS inward irritability

    score

    Mellow N Bumps Mean

    Minimum Maximum Std. Deviation

    7 7 7 7 7 10.71 6.57 5.29 3.86 2.14

    7 4 3 1 0 20 13 10 9 4

    4.957 3.309 2.563 2.854 1.574 CHiP N Mean

    Minimum Maximum Std. Deviation

    6 6 6 6 6 4.83 4.67 3.17 2.00 .83

    1 1 0 0 0 10 8 8 3 2

    3.251 2.658 2.714 1.265 .753 Care-as- N usual Mean

    Minimum Maximum Std. Deviation

    10 10 10 10 10 7.90 5.50 4.60 2.80 1.20

    0 2 0 0 0 19 10 11 7 6

    6.887 2.915 4.061 2.251 1.814 Total N Mean

    Minimum Maximum Std. Deviation

    23 23 23 23 23 7.96 5.61 4.43 2.91 1.39

    0 1 0 0 0 20 13 11 9 6

    5.796 2.935 3.300 2.275 1.559

    Table 15: Outcome measures post-intervention

    23

  • 8-12 weeks post-birth

    EPDS score AWS depression

    score

    AWS anxiety score

    AWS outward

    irritability score

    AWS inward irritability

    score

    Mellow N Bumps Mean

    Minimum Maximum Std. Deviation

    9 9 9 9 9 5.22 3.44 3.56 2.00 .89

    0 0 0 0 0 10 6 6 6 3

    2.906 1.878 1.944 1.936 1.269 CHiP N Mean

    Minimum Maximum Std. Deviation

    5 5 5 5 5 2.80 3.00 2.80 1.60 .80

    0 1 0 0 0 10 7 10 3 4

    4.147 2.345 4.087 1.140 1.789 Care-as- N usual Mean

    Minimum Maximum Std. Deviation

    9 7 9 9 9 5.56 5.14 4.00 2.89 .67

    0 1 0 0 0 16 10 11 5 3

    6.146 4.259 4.822 2.028 1.118 Total N Mean

    Minimum Maximum Std. Deviation

    23 21 23 23 23 4.83 3.90 3.57 2.26 .78

    0 0 0 0 0 16 10 11 6 4

    4.599 2.965 3.616 1.839 1.278

    Table 16: Outcome measures 8-12 weeks post-birth

    Mellow Bumps vs Care- as-usual

    Group allocation

    N

    Mean

    Std. Deviation

    Std. Error Mean

    EDPS score pre- Mellow Bumps 10 14.10 4.358 1.378 intervention Care-as-usual 11 9.27 6.987 2.107 AWS depression score Mellow Bumps 10 7.00 2.108 .667 pre-intervention Care-as-usual 11 5.00 2.608 .786 AWS anxiety score pre- Mellow Bumps 10 6.30 2.791 .883 intervention Care-as-usual 11 5.36 4.653 1.403 AWS outward irritability Mellow Bumps 10 4.80 2.821 .892 score pre-intervention Care-as-usual 11 3.09 2.343 .707 AWS inward irritablity Mellow Bumps 10 2.80 2.044 .646 score pre-intervention Care-as-usual 11 2.27 1.902 .574

    Table 17: Baseline outcome measures means: Mellow Bumps group compared to Care-as- usual group

    24

  • Independent Samples Test: MB vs

    CAU

    Levene's Test for Equality of

    Variances

    t-test for Equality of Means

    F

    Sig.

    T

    df

    Sig. (2- tailed)

    Mean Difference

    Std. Error Difference

    95% Confidence Interval of the

    Difference Lower Upper

    EDPS Equal score pre- variances interventi assumed on Equal

    variances not assumed

    2.920 0.104 1.876 19 0.076 4.827 2.573 -0.559 10.213

    1.918 16.942 0.072 4.827 2.517 -0.485 10.140

    AWS Equal depressio variances n score assumed pre- Equal interventi variances on not

    assumed

    .807 0.380 1.920 19 0.070 2.000 1.042 -0.180 4.180

    1.940 18.769 0.068 2.000 1.031 -0.159 4.159

    AWS Equal anxiety variances score pre- assumed interventi Equal on variances

    not assumed

    6.587 0.019 0.552 19 0.588 0.936 1.697 -2.616 4.488

    0.565 16.593 0.580 0.936 1.658 -2.567 4.440

    AWS Equal outward variances irritability assumed score pre- Equal interventi variances on not

    assumed

    .211 0.651 1.516 19 0.146 1.709 1.127 -.651 4.069

    1.502 17.601 0.151 1.709 1.138 -.685 4.104

    AWS Equal inward variances irritablity assumed score pre- Equal interventi variances on not

    assumed

    .025 0.877 0.612 19 0.548 0.527 0.861 -1.275 2.329

    0.610 18.455 0.549 0.527 0.864 -1.285 2.340

    Table 18: Independent t-test baseline outcome measures: Mellow Bumps compared to Care- as-usual

    Chill-out In Pregnancy vs Care-as-usual

    Group allocation

    N

    Mean

    Std. Deviation

    Std. Error Mean

    EDPS score pre- CHiP 9 11.00 6.595 2.198 intervention Care-as-usual 11 9.27 6.987 2.107 AWS depression score CHiP 9 6.00 2.550 .850 pre-intervention Care-as-usual 11 5.00 2.608 .786 AWS anxiety score pre- CHiP 9 6.78 3.734 1.245 intervention Care-as-usual 11 5.36 4.653 1.403 AWS outward irritability CHiP 9 3.11 2.315 .772 score pre-intervention Care-as-usual 11 3.09 2.343 .707 AWS inward irritablity CHiP 9 2.33 1.732 .577 score pre-intervention Care-as-usual 11 2.27 1.902 .574

    Table 19: Baseline outcome measure means: Chill-out in Pregnancy compared to Care-as- usual groups

    25

  • Independent Samples

    Test: CHiP vs CAU

    Levene's Test for Equality of Variances

    t-test for Equality of Means

    F

    Sig.

    T

    df

    Sig. (2- tailed)

    Mean

    Differenc e

    Std. Error Difference

    95% Confidence Interval of the

    Difference Lower Upper

    EDPS score Equal pre- variances intervention assumed

    Equal variances not assumed

    0.093 0.764 0.564 18 0.580 1.727 3.063 -4.709 8.163

    0.567 17.579 0.578 1.727 3.045 -4.681 8.135

    AWS Equal depression variances score pre- assumed intervention Equal

    variances not assumed

    0.093 0.764 0.862 18 0.400 1.000 1.161 -1.438 3.438

    0.864 17.373 0.399 1.000 1.158 -1.439 3.439

    AWS anxiety Equal score pre- variances intervention assumed

    Equal variances not assumed

    1.873 0.188 0.737 18 0.471 1.414 1.919 -2.617 5.446

    0.754 17.999 0.461 1.414 1.876 -2.526 5.355

    AWS Equal outward variances irritability assumed score pre- Equal intervention variances

    not assumed

    0.104 0.750 0.019 18 0.985 0.020 1.048 -2.181 2.221

    0.019 17.304 0.985 0.020 1.046 -2.184 2.225

    AWS inward Equal irritablity variances score pre- assumed intervention Equal

    variances not assumed

    0.155 0.698 0.074 18 0.942 0.061 0.822 -1.666 1.787

    0.074 17.751 0.941 0.061 0.814 -1.651 1.772

    Table 20: Independent t-test baseline outcome measures: Chill-out in Pregnancy compared to Care-as-usual groups

    26

  • Mellow Bumps vs Chill- out in Pregnancy

    Group allocation

    N

    Mean

    Std. Deviation

    Std. Error Mean

    EDPS score pre- Mellow Bumps 10 14.10 4.358 1.378 intervention CHiP 9 11.00 6.595 2.198 AWS depression score Mellow Bumps 10 7.00 2.108 .667 pre-intervention CHiP 9 6.00 2.550 .850 AWS anxiety score pre- Mellow Bumps 10 6.30 2.791 .883 intervention CHiP 9 6.78 3.734 1.245 AWS outward irritability Mellow Bumps 10 4.80 2.821 .892 score pre-intervention CHiP 9 3.11 2.315 .772 AWS inward irritablity Mellow Bumps 10 2.80 2.044 .646 score pre-intervention CHiP 9 2.33 1.732 .577 Table 21: Baseline outcome measure means: Mellow Bumps compared to Chill-out in

    Pregnancy group

    Independent Samples

    Test: MB vs CHiP

    Levene's Test for Equality of Variances

    t-test for Equality of Means

    F

    Sig.

    T

    df

    Sig. (2-

    tailed)

    Mean Difference

    Std. Error Difference

    95% Confidence

    Interval of the Difference

    Lower Upper EDPS score Equal pre- variances intervention assumed

    Equal variances not assumed

    1.727 0.206 1.221 17 0.239 3.100 2.538 -2.256 8.456

    1.195 13.648 0.253 3.100 2.595 -2.478 8.678

    AWS Equal depression variances score pre- assumed intervention Equal

    variances not assumed

    0.261 0.616 0.936 17 0.363 1.000 1.069 -1.255 3.255

    0.926 15.618 0.369 1.000 1.080 -1.294 3.294

    AWS Equal anxiety variances score pre- assumed intervention Equal

    variances not assumed

    0.579 0.457 -0.318 17 0.754 -0.478 1.502 -3.647 2.691

    -0.313 14.751 0.759 -0.478 1.526 -3.735 2.779

    AWS Equal outward variances irritability assumed score pre- Equal intervention variances

    not assumed

    0.457 0.508 1.416 17 0.175 1.689 1.192 -.827 4.205

    1.432 16.878 0.170 1.689 1.180 -.801 4.179

    AWS inward Equal irritablity variances score pre- assumed intervention Equal

    variances not assumed

    0.258 0.618 0.534 17 0.601 0.467 0.875 -1.379 2.312

    0.538 16.951 0.597 0.467 0.867 -1.362 2.296

    Table 22: Independent t-test baseline outcome measures: Mellow Bumps compared to Chill- out in Pregnancy groups

    27

  • ANCOVA: Tests of Between-Subjects Effects Dependent Variable: EPDS score post-intervention

    Source

    Type III Sum of Squares

    df

    Mean Square

    F

    Sig.

    Corrected Model Intercept

    EPDS PRE GROUP ALLOCATION Error

    Total Corrected Total

    326.389a 24.691 214.594 74.056 412.568 2195.000 738.957

    3 1 1 2 19 23 22

    108.796 24.691 214.594 37.028 21.714

    5.010 1.137 9.883 1.705

    .010

    .300

    .005

    .208

    a. R Squared = .442 (Adjusted R Squared = .354)

    Table 23: EPDS score post-intervention compared to pre-intervention

    ANCOVA: Tests of Between-Subjects Effects Dependent Variable: EPDS score @ 8-12 weeks

    Source

    Type III Sum of Squares

    df

    Mean Square

    F

    Sig.

    Corrected Model Intercept

    EPDS PRE GROUP ALLOCATION Error

    Total Corrected Total

    305.493a 20.956 278.767 50.670 159.811 1001.000 465.304

    3 1 1 2 19 23 22

    101.831 20.956 278.767 25.335 8.411

    12.107 2.491 33.143 3.012

    .000

    .131

    .000

    .073

    a. R Squared = .657 (Adjusted R Squared = .602)

    Table 24: EPDS score at 8-12 weeks post-birth compared to pre-intervention

    ANCOVA: Tests of Between-Subjects Effects Dependent Variable: AWS depression score post-intervention

    Source

    Type III Sum of Squares

    df

    Mean Square

    F

    Sig.

    Corrected Model Intercept

    AWS-depression PRE GROUP ALLOCATION

    Error Total

    Corrected Total

    82.737a 2.941 70.806 13.037 106.742 913.000 189.478

    3 1 1 2 19 23 22

    27.579 2.941 70.806 6.518 5.618

    4.909 .524

    12.603 1.160

    .011

    .478

    .002

    .335

    a. R Squared = .437 (Adjusted R Squared = .348)

    Table 25: AWS-depression score post-intervention post-birth compared to pre-intervention

    ANCOVA: Tests of Between-Subjects Effects Dependent Variable: AWS depression score @ 8-12 weeks

    Source

    Type III Sum of Squares

    df

    Mean Square

    F

    Sig.

    Corrected Model Intercept

    AWS-depression PRE GROUP ALLOCATION

    Error Total

    Corrected Total

    35.026a 3.157 18.296 23.288 140.784 496.000 175.810

    3 1 1 2 17 21 20

    11.675 3.157 18.296 11.644 8.281

    1.410 .381 2.209 1.406

    .274

    .545

    .155

    .272

    a. R Squared = .199 (Adjusted R Squared = .058)

    Table 26: AWS-depression score at 8-12 weeks post-birth compared to pre-intervention

    28

  • ANCOVA: Tests of Between-Subjects Effects Dependent Variable: AWS anxiety score post-intervention

    Source

    Type III Sum of Squares

    df

    Mean Square

    F

    Sig.

    Corrected Model Intercept AWS-

    anxiety PRE GROUP ALLOCATION Error

    Total Corrected Total

    153.667a .336

    138.676 24.681 85.986 692.000 239.652

    3 1 1 2 19 23 22

    51.222 .336

    138.676 12.341 4.526

    11.318 .074

    30.643 2.727

    .000

    .788

    .000

    .091

    a. R Squared = .641 (Adjusted R Squared = .585)

    Table 27: AWS-anxiety score post-intervention post-birth compared to pre-intervention

    ANCOVA: Tests of Between-Subjects Effects Dependent Variable: AWS anxiety score @ 8-12 weeks

    Source

    Type III Sum of Squares

    df

    Mean Square

    F

    Sig.

    Corrected Model Intercept AWS-

    anxiety PRE GROUP ALLOCATION Error

    Total Corrected Total

    152.915a 4.300

    148.285 12.062 134.737 580.000 287.652

    3 1 1 2 19 23 22

    50.972 4.300

    148.285 6.031 7.091

    7.188 .606

    20.911 .850

    .002

    .446

    .000

    .443

    a. R Squared = .532 (Adjusted R Squared = .458)

    Table 28: AWS-anxiety score at 8-12 weeks post-birth compared to pre-intervention

    ANCOVA: Tests of Between-Subjects Effects Dependent Variable: AWS outward irritability score post-intervention

    Source

    Type III Sum of Squares

    df

    Mean Square

    F

    Sig.

    Corrected Model Intercept

    AWS-outward irritability

    GROUP ALLOCATION Error Total

    Corrected Total

    83.833a .546

    72.464

    3.003 29.993 309.000 113.826

    3 1 1

    2 19 23 22

    27.944 .546

    72.464

    1.502 1.579

    17.702 .346

    45.905

    .951

    .000

    .563

    .000

    .404

    a. R Squared = .737 (Adjusted R Squared = .695)

    Table 29: AWS-outward irritability score post-intervention post-birth compared to pre-intervention

    ANCOVA: Tests of Between-Subjects Effects Dependent Variable: AWS outward irritability score @ 8-12 weeks

    Source

    Type III Sum of Squares

    df

    Mean Square

    F

    Sig.

    Corrected Model Intercept AWS

    outward irritability PRE GROUP ALLOCATION

    Error Total

    Corrected Total

    16.103a 8.625 9.757

    9.293 58.332 192.000 74.435

    3 1 1

    2 19 23 22

    5.368 8.625 9.757

    4.647 3.070

    1.748 2.810 3.178

    1.514

    .191

    .110

    .091

    .246

    a. R Squared = .216 (Adjusted R Squared = .093)

    Table 30: AWS-outward irritability score at 8-12 weeks post-birth compared to pre-interventio

    29

  • ANCOVA: Tests of Between-Subjects Effects Dependent Variable: AWS inward irritability score post-intervention

    Source

    Type III Sum of Squares

    df

    Mean Square

    F

    Sig.

    Corrected Model Intercept

    AWS inward irritability

    GROUP ALLOCATION Error Total

    Corrected Total

    18.978a .938

    12.790

    2.998 34.500 98.000 53.478

    3 1 1

    2 19 23 22

    6.326 .938

    12.790

    1.499 1.816

    3.484 .517 7.044

    .826

    .036

    .481

    .016

    .453

    a. R Squared = .355 (Adjusted R Squared = .253)

    Table 31: AWS-inward irritability score post-intervention post-birth compared to pre-intervention

    ANCOVA: Tests of Between-Subjects Effects Dependent Variable: AWS inward irritability score @ 8-12 weeks

    Source

    Type III Sum of Squares

    df

    Mean Square

    F

    Sig.

    Corrected Model Intercept

    AWS-inward irritability PRE

    GROUP ALLOCATION Error Total

    Corrected Total

    4.870a .235 4.646

    .056

    31.043 50.000 35.913

    3 1 1

    2 19 23 22

    1.623 .235 4.646

    .028 1.634

    .994

    .144 2.843

    .017

    .417

    .708

    .108

    .983

    a. R Squared = .136 (Adjusted R Squared = -.001)

    Table 32: AWS-inward irritability at 8-12 weeks post-birth compared to pre-intervention

    30

  • Group allocation

    N

    Minimum

    Maximum

    Mean

    Std. Deviation

    Mellow cortisol level pre-intervention Bumps day 1, time, 1 (nmol/l))

    cortisol level pre-intervention day 1, time 2 (nmol/l)) cortisol level pre-intervention day 1, time 3 (nmol/l)) cortisol level pre-intervention day 2, time 1 (nmol/l)) cortisol level pre-intervention day 2, time 2 (nmol/l)) cortisol level pre-intervention day 2, time 3 (nmol/l))

    4 14.1 24.8 20.275 5.0592

    4 4.5 36.0 19.850 12.8868

    4 3.7 9.0 5.950 2.2428

    4 8.5 24.0 15.875 6.9906

    4 6.6 24.5 14.550 7.4011

    3 1.8 9.4 5.433 3.8109

    CHiP cortisol level pre-intervention day 1, time, 1 (nmol/l)) cortisol level pre-intervention day 1, time 2 (nmol/l)) cortisol level pre-intervention day 1, time 3 (nmol/l)) cortisol level pre-intervention day 2, time 1 (nmol/l)) cortisol level pre-intervention day 2, time 2 (nmol/l) cortisol level pre-intervention day 2, time 3 (nmol/l)

    1 24.4 24.4 24.400 .

    1 12.8 12.8 12.800 .

    1 3.9 3.9 3.900 .

    1 10.9 10.9 10.900 .

    1 19.2 19.2 19.200 .

    1 6.5 6.5 6.500 .

    Care- cortisol level pre-intervention as- day 1, time, 1 (nmol/l) usual cortisol level pre-intervention

    day 1, time 2 (nmol/l) cortisol level pre-intervention day 1, time 3 (nmol/l) cortisol level pre-intervention day 2, time 1 (nmol/l) cortisol level pre-intervention day 2, time 2 (nmol/l) cortisol level pre-intervention day 2, time 3 (nmol/l)

    7 9.5 30.1 18.643 7.5875

    6 7.1 26.4 13.300 6.7219

    7 1.2 15.2 5.686 5.9698

    6 7.0 27.6 16.800 7.1685

    6 3.7 22.8 12.967 7.7668

    6 1.3 7.8 3.400 2.2521

    Table 33: Pre-Intervention cortisol assays by group allocation

    31

  • Group allocation

    N

    Minimum

    Maximu m

    Mean

    Std. Deviation

    Mellow Bumps cortisol level post- intervention

    Nil Samples

    CHiP cortisol level post- intervention day 1, time 1 (nmol/l) cortisol level post- intervention day 1, time 2 (nmol/l) cortisol level post- intervention day 1, time 3 (nmol/l) cortisol level post- intervention day 2, time 1 (nmol/l) cortisol level post- intervention day 2, time 2 (nmol/l) cortisol level post- intervention day 2, time 3 (nmol/l))

    3 7.9 12.8 11.100 2.7731

    3 8.4 47.6 23.300 21.2233

    3 4.6 18.1 9.300 7.6269

    2 16.7 24.0 20.350 5.1619

    3 18.4 22.6 21.000 2.2716

    3 4.5 9.3 6.633 2.4440

    Care-as-usual cortisol level post- intervention day 1, time 1 (nmol/l) cortisol level post- intervention day 1, time 2 (nmol/l) cortisol level post- intervention day 1, time 3 (nmol/l) cortisol level post- intervention day 2, time 1 (nmol/l) cortisol level post- intervention day 2, time 2 (nmol/l) cortisol level post- intervention day 2, time 3 (nmol/l)

    2 13.3 17.8 15.550 3.1820

    2 10.5 11.3 10.900 .5657

    2 4.4 5.2 4.800 .5657

    2 8.8 13.9 11.350 3.6062

    2 9.8 13.4 11.600 2.5456

    2 6.0 12.4 9.200 4.5255

    Table 34: Post-intervention cortisol assays by group allocation

    32

  • Group allocation

    N

    Minimum

    Maximum

    Mean

    Std. Deviation

    Mellow cortisol @ day 1, time 1 Bumps (nmol/l)

    cortisol @ 8-12 weeks day 1, time 2 (nmol/l) cortisol @ 8-12 weeks day 1, time 3 (nmol/l) cortisol @ 8-12 weeks day 2, time 1 (nmol/l) cortisol @ 8-12 weeks day 2, time 2 (nmol/l) cortisol @ 8-12 weeks day 2, time 3 (nmol/l)

    2 10.1 11.2 10.650 .7778

    2 2.8 3.0 2.900 .1414

    1 6.2 6.2 6.200 .

    2 8.0 19.8 13.900 8.3439

    1 3.1 3.1 3.100 .

    2 4.4 9.3 6.850 3.4648

    CHiP cortisol @ 8-12 weeks Nil Samples

    Care-as- cortisol @ 8-12 weeks usual day 1, time 1 (nmol/l)

    cortisol @ 8-12 weeks day 1, time 2 (nmol/l) cortisol @ 8-12 weeks day 1, time 3 (nmol/l) cortisol @ 8-12 weeks day 2, time 1 (nmol/l) cortisol @ 8-12 weeks day 2, time 2 (nmol/l) cortisol @ 8-12 weeks day 2, time 3 (nmol/l)

    2 8.7 11.8 10.250 2.1920

    2 7.8 10.5 9.150 1.9092

    2 8.1 18.4 13.250 7.2832

    2 6.7 19.9 13.300 9.3338

    2 7.3 10.5 8.900 2.2627

    2 7.1 10.1 8.600 2.1213

    Table 35: 8-12 week post-birth cortisol assays by group allocation

    33

  • Group allocation

    Statistic

    Std. Error

    Video positive rate per second

    22.398, df 2, p=0.302*

    Mellow Mean Bumps 95% Confidence Lower Bound

    Interval for Mean Upper Bound Median Std. Deviation Minimum Maximum Skewness Kurtosis

    .0750 .01763

    .0333

    .1167

    .0850 .04986

    .01

    .16 .277 .752

    -.333 1.481 CHiP Mean

    95% Confidence Lower Bound Interval for Mean Upper Bound Median Std. Deviation Minimum Maximum Skewness Kurtosis

    .1240 .01860

    .0724

    .1756

    .1400 .04159

    .08

    .17 -.297 .913

    -2.781 2.000 Care-as- Mean usual 95% Confidence Lower Bound

    Interval for Mean Upper Bound Median Std. Deviation Minimum Maximum Skewness Kurtosis

    .1060 .01470

    .0652

    .1468

    .1000 .03286

    .07

    .14 .166 .913

    -2.845 2.000 * Kruskal Wallis Test

    Table 36: Positive mother-infant interactions (rate per sec) by group allocation

    34

  • Video negative rate per second

    21.097, df 2, p=0.578*

    Mellow Mean Bumps 95% Confidence Lower Bound

    Interval for Mean Upper Bound Median Std. Deviation Minimum Maximum Skewness Kurtosis

    .0175 .00559

    .0043

    .0307

    .0200 .01581

    .00

    .04 -.036 .752

    -1.682 1.481 CHiP Mean

    95% Confidence Lower Bound Interval for Mean Upper Bound Median Std. Deviation Minimum Maximum Skewness Kurtosis

    .0120 .00800 -.0102 .0342 .0000

    .01789 .00 .04

    1.258 .913 .313 2.000

    Care-as- Mean usual 95% Confidence Lower Bound

    Interval for Mean Upper Bound Median Std. Deviation Minimum Maximum Skewness Kurtosis

    .0080 .00374 -.0024 .0184 .0100

    .00837 .00 .02

    .512 .913 -.612 2.000

    * Kruskal Wallis Test

    Table 37: Negative mother-infant interactions (rate per sec.) by group allocation

    35