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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01494831
Recruitment Status : Completed
First Posted : December 19, 2011
Last Update Posted : January 18, 2012
Information provided by (Responsible Party):
John McMullen, 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).

Condition or disease Intervention/treatment Phase
Post-traumatic Stress Disorder Depression Conduct Disorder Behavioral: TF-CBT Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Study Start Date : May 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in post-traumatic stress symptoms measured by UCLA-PTSD-RI [ Time Frame: Post-intervention and 3 month ]

Secondary Outcome Measures :
  1. Change in psychosocial distress- measures by African Youth Psychosocial Assessment [ Time Frame: Post-intervention and 3 month ]
    Psychosocial distress- depression, anxiety, conduct problems, antisocial behaviour

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01494831

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: John McMullen, Principal Investigator, Queen's University, Belfast Identifier: NCT01494831     History of Changes
Other Study ID Numbers: PREC23
First Posted: December 19, 2011    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Conduct Disorder
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders