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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 15, 2011

Last Updated Date

January 17, 2012

Start Date ^ICMJE

May 2011

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in post-traumatic stress symptoms measured by UCLA-PTSD-RI [ Time Frame: Post-intervention and 3 month ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Reduction in post-traumatic stress symptoms measured by UCLA-PTSD-RI [ Time Frame: Post-intervention and 3 month ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01494831 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Reduction in psychosocial distress- measures by African Youth Psychosocial Assessment [ Time Frame: Post-intervention and 3 month ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Post-traumatic Stress Disorder
Depression
Conduct Disorder

Intervention ^ICMJE

Behavioral: TF-CBT

15 sessions of group-based, trauma-focused cognitive behavioral therapy

Other Name: Trauma-focused Cognitive Behavioral Therapy

Study Arm (s)

Experimental: TF-CBT
Intervention: Behavioral: TF-CBT
No Intervention: Waiting List control

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2011

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

War-affected children and adolescents

Exclusion Criteria:

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

Gender

Male

Ages

13 Years to 17 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01494831

Other Study ID Numbers ^ICMJE

PREC23

Has Data Monitoring Committee

Yes

Responsible Party

John McMullen, Queen's University, Belfast

Study Sponsor ^ICMJE

Queen's University, Belfast

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Harry Dr Rafferty

Queens University Belfast

Information Provided By

Queen's University, Belfast

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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