Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000256077
Ethics application status
Approved
Date submitted
9/02/2010
Date registered
25/03/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Community HUGS: A randomised controlled trial of a specialised mother-infant playgroup for women recovering from postnatal depression
Scientific title
Community HUGS: A randomised controlled trial of a specialised playgroup for improving the mother-infant relationship following postnatal depression
Secondary ID [1] 1546 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postnatal depression 256789 0
Condition category
Condition code
Mental Health 256936 256936 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Community HUGS. is a specialised 10-week therapeutic playgroup to promote the relationship between mother and infant by learning positive ways to communicate with each other. Sessions are delivered in group format with facilitators following a detailed manual. Sessions last approximately one hour (once a week for 10 weeks) and are followed by an informal chat and refreshments.
Intervention code [1] 255994 0
Treatment: Other
Comparator / control treatment
Waitlist control condition - Mother-infant pairs will be offered participation in a Community HUGS playgroup after a 10-week waiting period.
Control group
Active

Outcomes
Primary outcome [1] 257815 0
Parenting Stress Index Short Form
Timepoint [1] 257815 0
Baseline, Post-treatment, 6 month follow-up (intervention condition only)
Secondary outcome [1] 263231 0
Parenting Sense of Competence Scale
Timepoint [1] 263231 0
Baseline, Post-treatment, 6 month follow-up (intervention condition only)

Eligibility
Key inclusion criteria
1. Mother with a baby less than 10 months of age.
2. Has had a score of 10 or higher on the Edinburgh Postnatal Depression Scale (EPDS) at some stage since the baby's birth or a clinical diagnosis of depression
3. If the woman scored 13 or above on the EPDS or she is currently depressed, she has consulted or has a plan to consult a health professional about her mental health.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant difficulty with the English language.

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. Treatment assignment is concealed from researchers, therapists 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
Open (masking not 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
9/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256498 0
Government body
Name [1] 256498 0
Department of Families, Housing, Community Services and Indigenous Affairs Community Investment Program
Country [1] 256498 0
Australia
Primary sponsor type
Hospital
Name
Parent-Infant Research Institute, Austin Health
Address
Heidelberg Repatriation Hospital, Level 1, South Wing, Centaur Building, 300 Waterdale Rd, Heidelberg Heights VIC 3081
Country
Australia
Secondary sponsor category [1] 255809 0
None
Name [1] 255809 0
Address [1] 255809 0
Country [1] 255809 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258545 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 258545 0
Henry Buck Building, Austin Hospital, 145 Studley Rd, Heidelberg VIC 3084
Ethics committee country [1] 258545 0
Australia
Date submitted for ethics approval [1] 258545 0
Approval date [1] 258545 0
04/02/2010
Ethics approval number [1] 258545 0
H2010/03793

Summary
Brief summary
Postnatal depression (PND) interferes with the interaction between mother and infant, which in turn has long-term implications for the child's development. Further, treatment for PND directed at elevating mood has not been found to improve mother-infant interactions. For this reason we developed Community HUGS - a specialised 10-session playgroup for improving mother-infant relationships following PND. The aim of this project is to evaluate Community HUGS in a randomised controlled trial. It is hypothesised that women receiving the Community HUGS intervention will show less parent-child dysfunctional interactions and parental distress and higher maternal self-efficacy than women in the waitlist control condition post-treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30823 0
Address 30823 0
Country 30823 0
Phone 30823 0
Fax 30823 0
Email 30823 0
Contact person for public queries
Name 14070 0
Ms Jennie Ericksen
Address 14070 0
Parent-Infant Research Institute, Dept. of Clinical & Health Psychology, Heidelberg Repatriation Hospital, 300 Waterdale Rd, Heidelberg Heights VIC 3081
Country 14070 0
Australia
Phone 14070 0
+61 3 9496 4496
Fax 14070 0
Email 14070 0
[email protected]
Contact person for scientific queries
Name 4998 0
Dr Charlene Schembri
Address 4998 0
Parent-Infant Research Institute, Dept. of Clinical & Health Psychology, Heidelberg Repatriation Hospital, 300 Waterdale Rd, Heidelberg Heights VIC 3081
Country 4998 0
Australia
Phone 4998 0
+61 3 9496 4496
Fax 4998 0
Email 4998 0
[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
SourceTitleYear of PublicationDOI
EmbaseA THERAPEUTIC PLAYGROUP FOR DEPRESSED MOTHERS AND THEIR INFANTS: FEASIBILITY STUDY AND PILOT RANDOMIZED TRIAL OF COMMUNITY HUGS.2018https://dx.doi.org/10.1002/imhj.21723
N.B. These documents automatically identified may not have been verified by the study sponsor.