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Trial registered on ANZCTR

Registration number

ACTRN12612001110875

Ethics application status

Approved

Date submitted

16/10/2012

Date registered

17/10/2012

Date last updated

17/10/2012

Type of registration

Retrospectively registered

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

nil

Universal Trial Number (UTN)

Trial acronym

HUGS

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Postnatal Depression

Condition category

Condition code

Mental Health

Depression

Reproductive Health and Childbirth

Childbirth and postnatal care

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Treatment: Other

Intervention code [2]

Behaviour

Intervention code [3]

Lifestyle

Comparator / control treatment

Attention placebo playgroup ('Playtime'). Participants in this condition receive the same treatment for postnatal depression in the 9-week manualised postnatal depression group program described above ('Getting Ahead of Postnatal Depression'). This is then followed by four weekly non-directive Playtime playgroup meetings (1.5 hours each) of mothers, infants and a facilitator in the same surroundings as HUGS but with no therapeutic work to control for the possible effects of group membership, additional sessions, and the presence of a facilitator. The Playtime playgroup has been developed to be consistent with what is currently provided in community playgroups. A facilitator will host the four non-directive sessions and provide an opportunity for informal discussion between mothers as well as time to play with the babies. Toys will be available for use. The facilitator will adhere to manualised guidelines to ensure the sessions are non-directive.

Control group

Placebo

Outcomes

Primary outcome [1]

Mean scores on the Parent-Child Early Relational Assessment

Timepoint [1]

1. Baseline
2. Post-Getting Ahead of Postnatal Depression program
3. Post-HUGS/Playtime playgroup
4. 6-month follow-up

Primary outcome [2]

Mean scores on the Parenting Stress Index

Timepoint [2]

1. Baseline
2. Post-Getting Ahead of Postnatal Depression program
3. Post-HUGS/Playtime playgroup
4. 6-month follow-up

Secondary outcome [1]

z-scores on the Ages and Stages Questionnaire

Timepoint [1]

1. Baseline
2. Post-Getting Ahead of Postnatal Depression program
3. Post-HUGS/Playtime playgroup
4. 6-month follow-up

Eligibility

Key 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

Minimum age

18 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Key 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

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Centralised administration of a coded, pre-generated allocation schedule by an independent person blind to coding. Allocation is concealed from researchers, psychologists and participants until the point of allocation.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

A variable-length permuted blocks, computer-generated random sequence.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/02/2012

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

beyondblue

Address [1]

PO Box 6100
Hawthorn West VIC 3122

Country [1]

Australia

Primary sponsor type

Individual

Name

Professor Jeannette Milgrom

Address

Parent-Infant Research Institute
Level 1, South Wing, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Rd
Heidelberg Heights VIC 3081

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

Austin Hospital
145 Studley Rd
Heidelberg VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

10/09/2012

Ethics approval number [1]

H2012/04745

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Charlene Schembri

Address

Parent-Infant Research Institute
Level 1, South Wing, Centaur Building
Heidelberg Repatriation Hospital
330 Waterdale Rd
Heidelberg Heights VIC 3081

Country

Australia

Phone

+61 3 9496 4496

Fax

+61 3 9496 4148

[email protected]

Contact person for scientific queries

Name

Dr Charlene Schembri

Address

Parent-Infant Research Institute
Level 1, South Wing, Centaur Building
Heidelberg Repatriation Hospital
330 Waterdale Rd
Heidelberg Heights VIC 3081

Country

Australia

Phone

+61 3 9496 4496

Fax

+61 3 9496 4148

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Improving the mother-infant relationship following postnatal depression: a randomised controlled trial of a brief intervention (HUGS).	2021	https://dx.doi.org/10.1007/s00737-021-01116-5

N.B. These documents automatically identified may not have been verified by the study sponsor.

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