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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612001110875
Acronym
HUGS
Enrollment
100
Registered
2012-10-17
Start date
2012-02-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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

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.

Sponsors

Professor Jeannette Milgrom
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. women 18 years of age or older 2. infant aged 3-9 months 3. clinical diagnosis of current major or minor depressive episode

Exclusion criteria

1. currently receiving treatment for depression (medication or therapy) 2. significant difficulty with English 3. medium to high suicide risk 4. current substance abuse, manic/hypomanic symptoms, or depression with psychotic features

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 7, 2026