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Trial registered on ANZCTR


Registration number
ACTRN12611000948998
Ethics application status
Approved
Date submitted
29/08/2011
Date registered
2/09/2011
Date last updated
6/01/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The efficacy and social validity of a group cognitive behavioural therapy for young migrants from war-affected countries
Scientific title
A pretest posttest 3-month follow-up cluster randomised controlled trial of a group intervention "Teaching Recovery Techniques" to prevent worsening of early posttraumatic stress symptoms in young migrants.
Secondary ID [1] 262948 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
posttraumatic stress disorder 270673 0
depression 270674 0
anxiety 270675 0
Condition category
Condition code
Mental Health 270848 270848 0 0
Anxiety
Mental Health 270880 270880 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The “Teaching Recovery Techniques” (Smith et al., 2000) is a group-based cognitive-behavioural therapy. It was developed for survivors of war or conflicts aged 8 years or older. In brief, the Teaching Recovery Techniques is a psycho-social-education intervention, aimed at educating children about their symptoms and teaching adaptive coping strategies which include creating self-coping statements, relaxation, and exposure strategies. The program was designed to prevent worsening of early symptoms rather than to treat severe clinical diagnoses. The intervention manual and workbook can be found at Children and War website (www.childrenandwar.org). Participants in the intervention groups will receive the manualised intervention while those in the control groups will not receive any intervention until the end of the trial. The intervention will be run for one hour a week for a total of 8 weeks and facilitated by two trained facilitators.Control groups will be offered the same intervention at the end of trial for ethical reason.
Intervention code [1] 269292 0
Prevention
Intervention code [2] 269322 0
Treatment: Other
Comparator / control treatment
Control group will be assessed before and after the waiting period using the same measures as the intervention condition. Participants in control group will not receive any forms of intervention during the waiting period but will be offered the program immediately after the intervention ended in the intervention group, i.e., 8-9 weeks after pretest. Participants who become distressed during the waiting period will be withdrawn from the study for immediate intervention according to the project crisis protocol.
Control group
Active

Outcomes
Primary outcome [1] 279527 0
Revised Impact of Event Scale (RIES-13) mean score
Timepoint [1] 279527 0
pretest, posttest and 3-months after intervention ended
Primary outcome [2] 279528 0
Birleson Depression Self-Rating scale (DSRS) mean score
Timepoint [2] 279528 0
pretest, posttest and 3-months after intervention ended
Primary outcome [3] 279529 0
Hopkins Symptom Checklist-37 for Adolescents (HSCL-37A) mean score
Timepoint [3] 279529 0
pretest, posttest and 3-months after intervention ended
Secondary outcome [1] 287846 0
Parent Strengths and Difficulties Questionnaire (SDQ) mean score
Timepoint [1] 287846 0
pretest, posttest and 3-months after intervention ended
Secondary outcome [2] 287847 0
Teacher Strengths and Difficulties Questionnaire (SDQ) mean score
Timepoint [2] 287847 0
pretest, posttest and 3-months after intervention ended
Secondary outcome [3] 287848 0
To evaluate social validity of the intervention, we employed the Quantitative and Qualitive Student and Parent Evaluation Schedule adapted from Roberts, kane, Thomson and Bishop's (2003) study. In each intervention session, students rated on a 5-point Likert scale how much they have enjoyed and have learnt from the session. At the end of the intervention, students and parents were interviewed separately using a semi-structured interview about the usefulness and appropriateness of the program.
Timepoint [3] 287848 0
Weekly and at the end of the intervention

Eligibility
Key inclusion criteria
exposure to war-related trauma before migrating to Australia, living in Australia for less than 7 years, and self-report symptoms of PTSD
Minimum age
11 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
diagnosis of PTSD, limited English proficiency, being a non-accompanied humanitarian entrant, and currently receiving psychological treatment for PTSD

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)
Cluster design was used to avoid contamination of intervention effect had individual design been used (Campbell, Elbourne & Altman, 2004). To achieve this, eligible participants from the same schools will be grouped together and receive the same condition. Willing participants will be recruited from public and private schools in Perth with high density of refugee students. Participating schools will be asked to refer students for screening. This is done based on what the schools know about students' family background and current functioning. In accordance with the specific ethical guidance regarding young people by the National Statement on Ethical Conduct in Human Research, we will contact the primary carers before approaching the students. Families referred by schools will be approached using several strategies, including parent information sessions, sending a brief information form to parents, and direct teacher-parents phone calls. Parents who express interest in the study will receive a Participant Information and consent form. The voluntary nature of the study will be emphasized and active consent, written or verbal, will be sought before screening. Students whose parents consented will be approached in schools during school hour. They will be given the Participant information letter and written consent will be collected before they are screened using the UCLA PTSD Index. Suitable participants will be grouped according to schools and then randomly allocated into intervention or control condition. Participants will be recruited before group allocation; therefore interviewers who screen the participants will be unaware of group allocation at assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
In order to improve group equivalence, schools will be match-paired by school type (public vs private), school level (primary vs secondary school), and socioenomic status. Each school in the pairs will be randomly allocated into either intervention or WL control group by the statistical supervisor of this study who had no clinical involvement in the study using a computer generating random number.
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
Completed
Date of first participant enrolment
Anticipated
2/02/2010
Actual
16/03/2010
Date of last participant enrolment
Anticipated
Actual
24/05/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 269752 0
University
Name [1] 269752 0
Curtin University
Country [1] 269752 0
Australia
Funding source category [2] 269753 0
Government body
Name [2] 269753 0
Healthway Research Starter Grant
Country [2] 269753 0
Australia
Primary sponsor type
Individual
Name
Chew Sia Ooi
Address
School of Psychology
Curtin University
GPO Box U1987, Perth,
Western Australia 6845.
Country
Australia
Secondary sponsor category [1] 268791 0
Individual
Name [1] 268791 0
Dr Rosie Rooney
Address [1] 268791 0
School of Psychology
Curtin University
GPO Box U1987, Perth,
Western Australia 6845.
Country [1] 268791 0
Australia
Secondary sponsor category [2] 268792 0
Individual
Name [2] 268792 0
A/Prof Clare Roberts
Address [2] 268792 0
School of Psychology
Curtin University
GPO Box U1987, Perth,
Western Australia 6845.
Country [2] 268792 0
Australia
Secondary sponsor category [3] 289193 0
Individual
Name [3] 289193 0
Dr Bernadette Wright
Address [3] 289193 0
West Australian Transcultural Mental Health Centre
50 Murray St, Perth, Western Australia 6000
Country [3] 289193 0
Australia
Secondary sponsor category [4] 289194 0
Individual
Name [4] 289194 0
Dr Robert Kane
Address [4] 289194 0
School of Psychology, Curtin University
GPO Box U1987, Perth, Western Australia 6845.
Country [4] 289194 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271718 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 271718 0
Ethics committee country [1] 271718 0
Australia
Date submitted for ethics approval [1] 271718 0
Approval date [1] 271718 0
02/07/2008
Ethics approval number [1] 271718 0
HR60/2008

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

Contacts
Principal investigator
Name 33089 0
Dr Chew Ooi
Address 33089 0
School of Psychology Curtin University
GPO Box U1987, Perth Western Australia 6845.
Country 33089 0
Australia
Phone 33089 0
+61431649511
Fax 33089 0
Email 33089 0
chewsia@gmail.com
Contact person for public queries
Name 16336 0
Chew Ooi
Address 16336 0
School of Psychology
Curtin University
GPO Box U1987,
Perth
WA 6845.
Country 16336 0
Australia
Phone 16336 0
+61(0)431649511
Fax 16336 0
Email 16336 0
chewsia@gmail.com
Contact person for scientific queries
Name 7264 0
Chew Ooi
Address 7264 0
School of Psychology
Curtin University
GPO Box U1987,
Perth
WA 6845.
Country 7264 0
Australia
Phone 7264 0
+61(0)431649511
Fax 7264 0
Email 7264 0
chewsia@gmail.com

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
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Documents added automatically
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