RecruitingACTRN12618001925235

Preventing Adverse Child Development Following Maternal Depression in Pregnancy

Prevention of Adverse Child Behavioural Development Following Treatment of Maternal Depression in Pregnancy with the Beating the Blues Before Birth Program


Sponsor

Professor Jeannette Milgrom

Enrollment

230 participants

Start Date

Dec 7, 2018

Study Type

Interventional

Conditions

Summary

Children of women depressed in pregnancy are likely to have an increased risk of behavioural problems such as anxiety, depression and attention deficit/hyperactivity, with effects on mental health lasting at least to adolescence. This study is a fully powered RCT (n=230 women and their infants) which will evaluate medium-term change in child outcomes following cognitive-behavioural therapy (CBT) for depression in pregnancy. We hypothesise that children in the intervention group will have fewer Internalising behavioural problems at the age of 24 months than children in the control group. Pregnant women (30 weeks or below) diagnosed with depression will be allocated to CBT intervention or to treatment as usual. During eight weekly CBT sessions, women will be provided with behavioural and cognitive strategies to help them recover from depression. Other child behavioural, motor and cognitive outcomes will also be assessed.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Depression during pregnancy is more common than many people realise, and research shows that children born to mothers who experienced depression in pregnancy have a higher risk of behavioural and emotional problems — including anxiety, depression, and attention difficulties — that can persist into adolescence. This study is testing whether offering cognitive-behavioural therapy (CBT) to pregnant women with depression can not only help the mother recover but also improve outcomes for the child. Pregnant women at 30 weeks or less who are diagnosed with depression are randomly assigned to receive eight weekly sessions of CBT or to continue with standard care. The children are assessed at 24 months for emotional and behavioural development, as well as motor and cognitive milestones. You may be eligible if you are a pregnant woman at 30 weeks or less with a diagnosis of depression, aged 18 or older, and can communicate adequately in English. Women with psychotic disorders, bipolar disorder, active substance abuse, who are already receiving treatment for depression (medication or psychotherapy), or who are in crisis requiring hospitalisation are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Women assigned to the intervention condition will receive an 8-week cognitive-behavioural therapy program for antenatal depression ('Beating the Blues Before Birth'). These 8 weekly 1-hour sessions co

Women assigned to the intervention condition will receive an 8-week cognitive-behavioural therapy program for antenatal depression ('Beating the Blues Before Birth'). These 8 weekly 1-hour sessions cover behavioural and cognitive strategies to recover from depression. Of these sessions, number 6 is a couple session and number 8 is dedicated for relapse prevention. Session content includes understanding antenatal depression & anxiety, pleasant activities, self-care & relaxation in pregnancy, assertiveness & self-esteem, expectations and transition to parenthood and developing a more helpful thinking style, challenging my internal critic. The couple session provides information and support to partners and includes strategies for effective communication. Women without a partner may choose to invite anyone who is involved in supporting them, e.g. friend, mother, etc. Treatments will be delivered by psychologists or provisional psychologists following a detailed manual designed specifically for pregnant women and previously evaluated in a pilot study (Milgrom et al. 2015). Following each CBT session, therapists will check off the items covered (or re-visited) from the manual and will not progress women to new sessions until all content is covered. Audio-recordings from a 10% subsample of intervention group women (with permission) will allow treatment fidelity checks.


Locations(4)

Austin Health - Heidelberg Repatriation Hospital - Heidelberg West

VIC, Australia

The Royal Women's Hospital - Parkville

VIC, Australia

Mercy Hospital for Women - Heidelberg

VIC, Australia

Monash Medical Centre - Clayton campus - Clayton

VIC, Australia

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ACTRN12618001925235