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

This study has been completed.
Information provided by (Responsible Party):
John McMullen, Queen's University, Belfast
ClinicalTrials.gov Identifier:
First received: December 15, 2011
Last updated: January 17, 2012
Last verified: January 2012
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
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.

Resource links provided by NLM:

Further study details as provided by Queen's University, Belfast:

Primary Outcome Measures:
  • Change in post-traumatic stress symptoms measured by UCLA-PTSD-RI [ Time Frame: Post-intervention and 3 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01494831

Sponsors and Collaborators
Queen's University, Belfast
Study Director: Harry Dr Rafferty Queens University Belfast
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
Conduct Disorder
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders
Neurodevelopmental Disorders
Pathologic Processes
Trauma and Stressor Related Disorders

ClinicalTrials.gov processed this record on May 22, 2016