Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000137392
Ethics application status
Approved
Date submitted
27/02/2008
Date registered
17/03/2008
Date last updated
17/03/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preventing adolescent depression in Mauritius
Scientific title
Preventing adolescent depression in Mauritius: A randomized controlled trial of a universal school-based program
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 2884 0
Condition category
Condition code
Mental Health 3022 3022 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention was 11 weekly 1-hour sessions of a group program developed to address the prevention of adolescent depression (The Resourceful Adolescent Program - Adolescent version). The manualised program included the following strategies: identify personal strengths, identify bodily cues and "self-talk", develop self-soothing strategies, challenge negative self-talk, develop social problem-solving skills, learn conflict resolution and make use of social resources.
Intervention code [1] 2614 0
Prevention
Comparator / control treatment
The control was a wait-list condition.
Control group
Active

Outcomes
Primary outcome [1] 3900 0
Symptoms of depression were assessed by self-report
Timepoint [1] 3900 0
Assessed at baseline (2 weeks before start of program), post-intervention, and a 6-month follow-up.
Secondary outcome [1] 6575 0
Coping skills and self-esteem were assessed by self-report
Timepoint [1] 6575 0
Assessed at baseline, post-intervention and a 6-month follow-up.

Eligibility
Key inclusion criteria
All students who provided consent (and parental consent) in years 7 and 9 from two schools in Mauritius were included in the study
Minimum age
12 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There were no specified exclusion criteria.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participating students were randomised to the Resourceful Adolescent Program - Adolescent version (RAP-A) or control condition on an individual level. Each student was allocated a study number and randomly allocated by the principal researcher using a predetermined random number sequence. Allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/08/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment outside Australia
Country [1] 808 0
Mauritius
State/province [1] 808 0

Funding & Sponsors
Funding source category [1] 3138 0
University
Name [1] 3138 0
Postgraduate Research Grant
Country [1] 3138 0
Australia
Primary sponsor type
Individual
Name
Dr Caroline Hunt
Address
School of Psychology
The University of Sydney
F12
Fisher Road
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 2818 0
Individual
Name [1] 2818 0
Dr Sandra Heriot
Address [1] 2818 0
School of Psychology
The University of Sydney
F12
Fisher Road
Camperdown NSW 2006
Country [1] 2818 0
Australia
Secondary sponsor category [2] 2819 0
Individual
Name [2] 2819 0
Dr Emilie Rivet-Duval
Address [2] 2819 0
Centre de Formation pour Educateurs
1 Rue Celicourt Antelme
Rose Hill
Country [2] 2819 0
Mauritius

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5107 0
The University of Sydney Human Ethics Committee
Ethics committee address [1] 5107 0
Ethics committee country [1] 5107 0
Australia
Date submitted for ethics approval [1] 5107 0
Approval date [1] 5107 0
23/06/2003
Ethics approval number [1] 5107 0
6807

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28410 0
Address 28410 0
Country 28410 0
Phone 28410 0
Fax 28410 0
Email 28410 0
Contact person for public queries
Name 11567 0
Dr Caroline Hunt
Address 11567 0
School of Psychology
The University of Sydney
F12
Fisher Road
Camperdown NSW 2006
Country 11567 0
Australia
Phone 11567 0
+61 2 93515446
Fax 11567 0
+61 2 93512984
Email 11567 0
[email protected]
Contact person for scientific queries
Name 2495 0
Dr Sandra Heriot
Address 2495 0
School of Psychology
The University of Sydney
F12
Fisher Road
Camperdown NSW 2006
Country 2495 0
Australia
Phone 2495 0
+61 2 93515446
Fax 2495 0
+61 2 93512984
Email 2495 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
No additional documents have been identified.