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

Sponsor
Queen's University, Belfast (Other)
Overall Status
Completed
CT.gov ID
NCT01494831
Collaborator
(none)
58
Enrollment
2
Arms
5
Duration (Months)

Study Details

Study Description

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
  • 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 Design

Study Type:
Interventional
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 1, 2011
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Oct 1, 2011

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Change in post-traumatic stress symptoms measured by UCLA-PTSD-RI [Post-intervention and 3 month]

    Secondary Outcome Measures

    1. Change in psychosocial distress- measures by African Youth Psychosocial Assessment [Post-intervention and 3 month]

      Psychosocial distress- depression, anxiety, conduct problems, antisocial behaviour

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years to 17 Years
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Queen's University, Belfast

    Investigators

    • Study Director: Harry Dr Rafferty, Queens University Belfast

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    John McMullen, Principal Investigator, Queen's University, Belfast
    ClinicalTrials.gov Identifier:
    NCT01494831
    Other Study ID Numbers:
    • PREC23
    First Posted:
    Dec 19, 2011
    Last Update Posted:
    Jan 18, 2012
    Last Verified:
    Jan 1, 2012
    Additional relevant MeSH terms:
    Disease
    Stress Disorders, Traumatic
    Stress Disorders, Post-Traumatic
    Conduct Disorder

    Study Results

    No Results Posted as of Jan 18, 2012