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

Primary Purpose

Post-traumatic Stress Disorder, Depression, Conduct Disorder

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
TF-CBT
Sponsored by
Queen's University, Belfast
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-traumatic Stress Disorder

Eligibility Criteria

13 Years - 17 Years (Child)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • War-affected children and adolescents

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    TF-CBT

    Waiting List control

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in post-traumatic stress symptoms measured by UCLA-PTSD-RI

    Secondary Outcome Measures

    Change in psychosocial distress- measures by African Youth Psychosocial Assessment
    Psychosocial distress- depression, anxiety, conduct problems, antisocial behaviour

    Full Information

    First Posted
    December 15, 2011
    Last Updated
    January 17, 2012
    Sponsor
    Queen's University, Belfast
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01494831
    Brief Title
    Randomized Control Trial of Group Intervention With Former War-affected Boys in the Democratic Republic of Congo
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2011 (undefined)
    Primary Completion Date
    July 2011 (Actual)
    Study Completion Date
    October 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Queen's University, Belfast

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-traumatic Stress Disorder, Depression, Conduct Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    58 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TF-CBT
    Arm Type
    Experimental
    Arm Title
    Waiting List control
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    TF-CBT
    Other Intervention Name(s)
    Trauma-focused Cognitive Behavioral Therapy
    Intervention Description
    15 sessions of group-based, trauma-focused cognitive behavioral therapy
    Primary Outcome Measure Information:
    Title
    Change in post-traumatic stress symptoms measured by UCLA-PTSD-RI
    Time Frame
    Post-intervention and 3 month
    Secondary Outcome Measure Information:
    Title
    Change in psychosocial distress- measures by African Youth Psychosocial Assessment
    Description
    Psychosocial distress- depression, anxiety, conduct problems, antisocial behaviour
    Time Frame
    Post-intervention and 3 month

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: War-affected children and adolescents Exclusion Criteria: No traumatic war events experienced Psychosis Inability to speak Swahili, French or English
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Harry Dr Rafferty
    Organizational Affiliation
    Queens University Belfast
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23738530
    Citation
    McMullen J, O'Callaghan P, Shannon C, Black A, Eakin J. Group trauma-focused cognitive-behavioural therapy with former child soldiers and other war-affected boys in the DR Congo: a randomised controlled trial. J Child Psychol Psychiatry. 2013 Nov;54(11):1231-41. doi: 10.1111/jcpp.12094. Epub 2013 Jun 6.
    Results Reference
    derived

    Learn more about this trial

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

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