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

January 17, 2012 updated by: John McMullen, Queen's University, Belfast

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

58

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • War-affected children and adolescents

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TF-CBT
Behavioral: TF-CBT
15 sessions of group-based, trauma-focused cognitive behavioral therapy
Other Names:
  • Trauma-focused Cognitive Behavioral Therapy
No Intervention: Waiting List control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in post-traumatic stress symptoms measured by UCLA-PTSD-RI
Time Frame: Post-intervention and 3 month
Post-intervention and 3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Post-intervention and 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University, Belfast

Investigators

  • Study Director: Harry Dr Rafferty, Queens University Belfast

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

December 15, 2011

First Submitted That Met QC Criteria

December 16, 2011

First Posted (Estimate)

December 19, 2011

Study Record Updates

Last Update Posted (Estimate)

January 18, 2012

Last Update Submitted That Met QC Criteria

January 17, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREC23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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