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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John McMullen, Queen's University, Belfast
ClinicalTrials.gov Identifier:
NCT01494831
First received: December 15, 2011
Last updated: January 17, 2012
Last verified: January 2012
  Purpose

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
Depression
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.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided by Queen's University, Belfast

Additional 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:
Depression
Stress Disorders, Traumatic
Disease
Stress Disorders, Post-Traumatic
Conduct Disorder
Behavioral Symptoms
Anxiety Disorders
Mental Disorders
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on October 01, 2014