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

Depression Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01494831
• Other study ID #: PREC23
• Status: Completed
• Phase: Phase 2
• First received: December 15, 2011
• Last updated: January 17, 2012
• Start date: May 2011
• Est. completion date: October 2011

Study information

• Verified date: January 2012
• Source: Queen's University, Belfast
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: October 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

• War-affected children and adolescents

Exclusion Criteria:

• No traumatic war events experienced

• Psychosis

• Inability to speak Swahili, French or English

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conduct Disorder
• Depression
• Disease
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• TF-CBT
15 sessions of group-based, trauma-focused cognitive behavioral therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University, Belfast

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in post-traumatic stress symptoms measured by UCLA-PTSD-RI		Post-intervention and 3 month	No
Secondary	Change in psychosocial distress- measures by African Youth Psychosocial Assessment	Psychosocial distress- depression, anxiety, conduct problems, antisocial behaviour	Post-intervention and 3 month	No