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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] 281376 0
nil
Universal Trial Number (UTN)
Trial acronym
HUGS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postnatal Depression 287602 0
Condition category
Condition code
Mental Health 287935 287935 0 0
Depression
Reproductive Health and Childbirth 287984 287984 0 0
Childbirth and postnatal care
Public Health 287985 287985 0 0
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] 285845 0
Treatment: Other
Intervention code [2] 285894 0
Behaviour
Intervention code [3] 285895 0
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] 288144 0
Mean scores on the Parent-Child Early Relational Assessment
Timepoint [1] 288144 0
1. Baseline
2. Post-Getting Ahead of Postnatal Depression program
3. Post-HUGS/Playtime playgroup
4. 6-month follow-up
Primary outcome [2] 288145 0
Mean scores on the Parenting Stress Index
Timepoint [2] 288145 0
1. Baseline
2. Post-Getting Ahead of Postnatal Depression program
3. Post-HUGS/Playtime playgroup
4. 6-month follow-up
Secondary outcome [1] 299498 0
z-scores on the Ages and Stages Questionnaire
Timepoint [1] 299498 0
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
Gender
Females
Can healthy volunteers participate?
No
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286130 0
Charities/Societies/Foundations
Name [1] 286130 0
beyondblue
Address [1] 286130 0
PO Box 6100
Hawthorn West VIC 3122
Country [1] 286130 0
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] 284942 0
None
Name [1] 284942 0
Address [1] 284942 0
Country [1] 284942 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288178 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 288178 0
Austin Hospital
145 Studley Rd
Heidelberg VIC 3084
Ethics committee country [1] 288178 0
Australia
Date submitted for ethics approval [1] 288178 0
Approval date [1] 288178 0
10/09/2012
Ethics approval number [1] 288178 0
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 34816 0
Address 34816 0
Country 34816 0
Phone 34816 0
Fax 34816 0
Email 34816 0
Contact person for public queries
Name 18063 0
Dr Charlene Schembri
Address 18063 0
Parent-Infant Research Institute
Level 1, South Wing, Centaur Building
Heidelberg Repatriation Hospital
330 Waterdale Rd
Heidelberg Heights VIC 3081
Country 18063 0
Australia
Phone 18063 0
+61 3 9496 4496
Fax 18063 0
+61 3 9496 4148
Email 18063 0
charlene.schembri@austin.org.au
Contact person for scientific queries
Name 8991 0
Dr Charlene Schembri
Address 8991 0
Parent-Infant Research Institute
Level 1, South Wing, Centaur Building
Heidelberg Repatriation Hospital
330 Waterdale Rd
Heidelberg Heights VIC 3081
Country 8991 0
Australia
Phone 8991 0
+61 3 9496 4496
Fax 8991 0
+61 3 9496 4148
Email 8991 0
charlene.schembri@austin.org.au

No information has been provided regarding IPD availability
Summary results
No Results