Randomized Control Trial of Group Intervention With Former War-affected Boys in the Democratic Republic of Congo

Phase 2

Completed

• Conditions: Post-traumatic Stress Disorder; Depression; Conduct Disorder
• Interventions: Behavioral: TF-CBT

• Registration Number: NCT01494831
• Lead Sponsor: Queen's University, Belfast

Brief Summary

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).

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.

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2011-07
• Study Completion: 2011-10
• Study First Submitted: 2011-12-15
• Study First Submitted QC: 2011-12-16
• Study First Posted: 2011-12-19
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-17
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 58

Inclusion Criteria

• War-affected children and adolescents

Exclusion Criteria

• No traumatic war events experienced
• Psychosis
• Inability to speak Swahili, French or English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TF-CBT	TF-CBT	-

Primary Outcome Measures

Name	Time	Method
Change in post-traumatic stress symptoms measured by UCLA-PTSD-RI	Post-intervention and 3 month

Secondary Outcome Measures

Name	Time	Method
Change in psychosocial distress- measures by African Youth Psychosocial Assessment	Post-intervention and 3 month	Psychosocial distress- depression, anxiety, conduct problems, antisocial behaviour