Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001237976
Ethics application status
Not yet submitted
Date submitted
30/11/2011
Date registered
5/12/2011
Date last updated
2/06/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Controlled Trial of a Traditional and Modified Healing Program for Enhancing Social Emotional Well-Being in Indigenous Australian Children
Scientific title
Randomised Controlled Trial of a Traditional and Modified Healing Program for Enhancing Social Emotional Well-Being in Indigenous Australian Children
Secondary ID [1] 273498 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social emotional well-being 279293 0
Condition category
Condition code
Mental Health 279489 279489 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two arms to this trial. Arm 1: Healing Program. Arm 2: Healing Program/CBT. Therapy is administered once-weekly over 5 weeks in a 3-hour group format, augmented with 3-once weekly one-on-one 1-hour sessions with a counsellor. Healing Program includes education about traditional indigenous knowledge and rituals, awareness raising of problems in communities and the historical context in which they have developed, and traditional practices to address current problems. The duration of the study for any participant will conclude after the 6-month follow-up assessment, resulting in participation duration of 8 months.
Intervention code [1] 283815 0
Behaviour
Comparator / control treatment
The Healing Program/Cognitive Behaviour Therapy condition is identical to the Healing Program and with additional elements.Therapy is administered once-weekly over 5 weeks in a 3-hour group format, augmented with 3-once weekly one-on-one 1-hour sessions with a counsellor. Healing Program includes education about traditional indigenous knowledge and rituals, awareness raising of problems in communities and the historical context in which they have developed, and traditional practices to address current problems. In addition, individual therapy involves recounting one's family history, and personal life and providing a narrative of positive and negative experiences. Specific skills are reviewed on managing grief responses. The duration of the study for any participant will conclude after the 6-month follow-up assessment, resulting in participation duration of 8 months.
Control group
Active

Outcomes
Primary outcome [1] 286053 0
Social Emotional Well Being as measured by the Strengths and Difficulties Questionnaire augmented by local qualitative questions.
Timepoint [1] 286053 0
Pretreatment, posttreatment, 6-Month Follow-up
Secondary outcome [1] 295046 0
Nil
Timepoint [1] 295046 0
Nil

Eligibility
Key inclusion criteria
Indigenous Australian children living in Broken Hill, Wilcannia, or Menindee
Minimum age
11 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe suicidal intent, psychotic

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)
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures): Participants will be treatment seeking adults who respond to public invitations in Broken Hill, Wilcannia, and Menindee. Participants will be randomly allocated according to a random numbers system administered by an individual who is independent of the study and who works at a site that is distant from the treatment center.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation): Randomization will be conducted by a process of minmization stratified on gender, locality, and severity of Social and Emotional Well-Being levels.
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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284287 0
Government body
Name [1] 284287 0
Australian Research Council
Country [1] 284287 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
School of Psychology, University of New South Wales, Anzac Parade, Kensington, Sydney, NSW, 2052
Country
Australia
Secondary sponsor category [1] 283239 0
Other Collaborative groups
Name [1] 283239 0
Maari Ma Health Aboriginal Corporation
Address [1] 283239 0
Shop 2, 443 Argent Street
Broken Hill, NSW, 2880
Country [1] 283239 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286248 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 286248 0
HREC
University of New South Wales
Sydney NSW 2052
Ethics committee country [1] 286248 0
Australia
Date submitted for ethics approval [1] 286248 0
01/12/2011
Approval date [1] 286248 0
Ethics approval number [1] 286248 0
Unknown
Ethics committee name [2] 291095 0
Aboriginal Health & Medical Research Council
Ethics committee address [2] 291095 0
Level 3, 66 Wentworth Ave
Surry Hills, NSW, 2010
Ethics committee country [2] 291095 0
Australia
Date submitted for ethics approval [2] 291095 0
05/04/2014
Approval date [2] 291095 0
Ethics approval number [2] 291095 0
1015/14

Summary
Brief summary
This study will randomly allocate participants to either (a) Healing Program, or (b) Healing Program + Cognitive Behaviour Therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33464 0
Prof Richard Bryant
Address 33464 0
School of Psychology
University of NSW
Sydney NSW 2052
Country 33464 0
Australia
Phone 33464 0
61293853640
Fax 33464 0
61293853641
Email 33464 0
[email protected]
Contact person for public queries
Name 16711 0
Prof Professor Richard Bryant
Address 16711 0
School of Psychology
University of New South Wales
Sydney, NSW, 2052
Country 16711 0
Australia
Phone 16711 0
61-2-93853640
Fax 16711 0
61-2-93853641
Email 16711 0
[email protected]
Contact person for scientific queries
Name 7639 0
Prof Professor Richard Bryant
Address 7639 0
School of Psychology
University of New South Wales
Sydney, NSW, 2052
Country 7639 0
Australia
Phone 7639 0
61-2-93853640
Fax 7639 0
61-2-93853641
Email 7639 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.