RecruitingACTRN12612001110875

Early intervention to protect the mother-infant relationship following postnatal depression - A randomised controlled trial

A randomised controlled trial evaluating the 'Happiness, Understanding, Giving and Sharing' (HUGS) program for improving mother-infant relationships among women with postnatal depression and their infants


Sponsor

Professor Jeannette Milgrom

Enrollment

100 participants

Start Date

Feb 1, 2012

Study Type

Interventional

Conditions

Summary

Approximately 40,000 Australian women annually experience postnatal depression. Postnatal depression interferes with mother-infant relationships, which can influence brain development and long-term cognitive and behavioural outcomes for the child. Current best practice treatment for postnatal depression generally involves treating only maternal mood. However, treatment focusing on maternal mood alone does not improve the mother-infant relationship. Therefore, it is important to directly target mother-infant difficulties as part of the routine care of postnatally depressed women. Existing mother-infant interventions targeted at women with postnatal depression are scarce, poorly-evaluated, of long duration, and have not been adapted for Australian use. This study aims to evaluate the effectiveness of a brief, cost-effective 4-week early intervention program that we developed to improve the mother-infant relationship (Happiness, Understanding, Giving & Sharing "HUGS"). This intervention is added to a 9-week evaluated program we previously developed for treatment of maternal postnatal depression. Treating existing depression first increases the emotional availability needed for optimal mother-infant interaction. The HUGS intervention has shown promising results in two pilot studies. In a randomised controlled trial comparing HUGS to an attention placebo playgroup (control group), the quality of the mother-infant relationship and developmental milestones will be assessed in 100 mother-infant dyads. It is hypothesised that women undergoing the combined postnatal depression treatment and HUGS program will show greater improvement compared to the control group who receive postnatal depression treatment followed by the attention placebo playgroup in: 1. The observed quality of the mother-infant interaction; and 2. Maternal reports of parenting stress, including feelings of attachment to their infant. It is also hypothesised that infants undergoing the HUGS program will show greater improvement compared to infants in the attention placebo playgroup, in terms of: 1. Difficult infant behaviour; and 2. Early developmental milestones.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a brief 4-week program called HUGS (Happiness, Understanding, Giving and Sharing) designed to strengthen the bond between mothers and their babies after postnatal depression. Postnatal depression affects around 40,000 Australian women each year, and it can interfere with the mother-baby relationship in ways that affect a child's brain development and long-term wellbeing. The HUGS program is delivered after completing a 9-week treatment for the depression itself, because treating mood first helps mothers become more emotionally available to their babies. You may be eligible if: - You are female and at least 18 years old - You have a current diagnosis of major or minor depression - Your baby is between 3 and 9 months old You may NOT be eligible if: - You are already receiving treatment for depression (medication or therapy) - You have significant difficulty with English - You are at medium or high risk of suicide - You currently have substance abuse, manic or hypomanic symptoms, or depression with psychotic features Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Happiness, Understanding, Giving and Sharing ('HUGS'). Participants in this condition receive treatment for postnatal depression in a 9-week manualised postnatal depression group program ('Getting Ahe

Happiness, Understanding, Giving and Sharing ('HUGS'). Participants in this condition receive treatment for postnatal depression in a 9-week manualised postnatal depression group program ('Getting Ahead of Postnatal Depression') followed by four weekly sessions (1.5 hours each) of HUGS mother-infant group treatment. The 9-week postnatal depression program consists of 9 weekly sessions for mothers only and 3 evening couple sessions held on different days to the mother-only session (12 sessions in total, 1.5 hours per session). The 9-week program addresses maternal mood, behavioural activation, cognitive strategies, self-esteeem, ways to "relax on the run", the couple relationship, getting support, practical issues, problem-solving and self-care from a cognitive-behavioural framework. The HUGS program includes psychoeducation and direct intervention in the mother-infant relationship as follows: Session 1. Play and physical contact: This allows interactional oportunities, assessment of interactional deficits and modelling of alternative responses. Session 2. Observing and understanding baby's signals: Essential elements of a 'good enough' interaction are taught. Session 3. Parental responses to infant cues: Building on cognitive strategies learnt, distorted cognitions are challenged. Session 4. Consolidating gains: Reinforcing positive interactional behaviours and cognitions about the infant. The group is facilitated by a psychologist.


Locations(1)

Australia

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