Randomized Control Trial of Group Intervention With Former War-affected Boys in the Democratic Republic of Congo
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Purpose
The purpose of this study is to evaluate, in a randomised control trial (RCT), the effectiveness of group-based, trauma-focused Cognitive Behaviour Therapy (TF-CBT) in reducing psychological distress in former child soldiers and other war-affected children in the Democratic Republic of Congo (DRC).
| Condition | Intervention | Phase |
|---|---|---|
|
Post-traumatic Stress Disorder Depression Conduct Disorder |
Behavioral: TF-CBT |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Evaluation of a Group-based, Cognitive-behavioural Intervention With Former Child Soldiers and Other War-affected Children in the Democratic Republic of Congo: A Randomised Controlled Trial. |
- Change in post-traumatic stress symptoms measured by UCLA-PTSD-RI [ Time Frame: Post-intervention and 3 month ] [ Designated as safety issue: No ]
- Change in psychosocial distress- measures by African Youth Psychosocial Assessment [ Time Frame: Post-intervention and 3 month ] [ Designated as safety issue: No ]Psychosocial distress- depression, anxiety, conduct problems, antisocial behaviour
| Enrollment: | 58 |
| Study Start Date: | May 2011 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: TF-CBT |
Behavioral: TF-CBT
15 sessions of group-based, trauma-focused cognitive behavioral therapy
Other Name: Trauma-focused Cognitive Behavioral Therapy
|
| No Intervention: Waiting List control |
Detailed Description:
To the best of the author's knowledge this is the first group-based mental health or psychosocial intervention developed specifically for psychologically distressed former child soldiers. While CBT is the modality with most empirical evidence for treating war-affected young people, this is the first evaluation with child soldiers specifically.
Former child soldiers and war affected 'street boys' (aged 13-17) in eastern DRC, will be screened for symptoms of psychological distress and then randomly assigned to either a treatment group or a waiting-list control. The treatment groups will receive a 15-session manualised, culturally-adapted, TF-CBT intervention. This includes psycho-education, relaxation, affect modulation, cognitive processing and constructing a trauma narrative. After treatment and post-testing, the waiting-list controls then begin their intervention.
Eligibility| Ages Eligible for Study: | 13 Years to 17 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- War-affected children and adolescents
Exclusion Criteria:
- No traumatic war events experienced
- Psychosis
- Inability to speak Swahili, French or English
Contacts and Locations More Information
No publications provided
| Responsible Party: | John McMullen, Principal Investigator, Queen's University, Belfast |
| ClinicalTrials.gov Identifier: | NCT01494831 History of Changes |
| Other Study ID Numbers: | PREC23 |
| Study First Received: | December 15, 2011 |
| Last Updated: | January 17, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Conduct Disorder Behavioral Symptoms |
Mood Disorders Mental Disorders Anxiety Disorders Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood |
ClinicalTrials.gov processed this record on May 21, 2013