NCT01494831

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2011

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2011

Completed
Last Updated

January 18, 2012

Status Verified

January 1, 2012

Enrollment Period

2 months

First QC Date

December 15, 2011

Last Update Submit

January 17, 2012

Conditions

Post-traumatic Stress DisorderDepressionConduct Disorder

Outcome Measures

Primary Outcomes (1)

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

    Post-intervention and 3 month

Secondary Outcomes (1)

  • Change in psychosocial distress- measures by African Youth Psychosocial Assessment

    Post-intervention and 3 month

Study Arms (2)

TF-CBT

EXPERIMENTAL
Behavioral: TF-CBT

Waiting List control

NO INTERVENTION

Interventions

TF-CBTBEHAVIORAL

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

Also known as: Trauma-focused Cognitive Behavioral Therapy
TF-CBT

Eligibility Criteria

Age13 Years - 17 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • War-affected children and adolescents

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 23738530DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepressionConduct Disorder

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehaviorAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental Disorders

Study Officials

  • Harry Dr Rafferty

    Queens University Belfast

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 15, 2011

First Posted

December 19, 2011

Study Start

May 1, 2011

Primary Completion

July 1, 2011

Study Completion

October 1, 2011

Last Updated

January 18, 2012

Record last verified: 2012-01