An RCT of Trauma Focused-Cognitive Behavioral Therapy With Sexually Exploited, War-affected Girls in the DRC
Is Trauma-Focused Cognitive Behavioral Therapy Effective in Reducing Post-traumatic Stress and Psychosocial Distress Among Sexually Exploited, War-affected Girls in the Democratic Republic of Congo.
1 other identifier
interventional
60
1 country
1
Brief Summary
To date, no RCT has examined the efficacy of Trauma-Focused Cognitive Behavioral Therapy with Sexually Exploited, War Affected Adolescent Girls in the Democratic Republic of Congo. This study seeks to fill this gap by designing, implementing and testing such an intervention using both an intervention and waiting list control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2011
Shorter than P25 for phase_2
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 29, 2011
CompletedFirst Posted
Study publicly available on registry
December 1, 2011
CompletedDecember 2, 2011
December 1, 2011
4 months
November 29, 2011
December 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Post-traumatic Stress Symptoms as measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index
baseline, post-intervention and 3-months
Secondary Outcomes (1)
Change in Psychosocial Distress as measured by the African Youth Psychosocial Assessment Instrument
baseline post-intervention and 3-months
Study Arms (2)
Trauma-Focused Cognitive Behavioral Therapy
EXPERIMENTALWaiting List Control
NO INTERVENTIONInterventions
15 sessions of manualised, culturally modified trauma-focused cognitive behavior therapy
Eligibility Criteria
You may qualify if:
- Suicidal ideation (irrespective of score on any other measure)
You may not qualify if:
- psychosis
- mental retardation
- inability to understand Swahili
- one standard deviation below the mean on every measure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Queen's University, Belfastlead
- World Visioncollaborator
Study Sites (1)
World Vision Rebound Centre
Beni, South Kivu, Republic of the Congo
Related Publications (1)
O'Callaghan P, McMullen J, Shannon C, Rafferty H, Black A. A randomized controlled trial of trauma-focused cognitive behavioral therapy for sexually exploited, war-affected Congolese girls. J Am Acad Child Adolesc Psychiatry. 2013 Apr;52(4):359-69. doi: 10.1016/j.jaac.2013.01.013. Epub 2013 Mar 6.
PMID: 23582867DERIVED
Study Officials
- STUDY DIRECTOR
Dr Ciaran Shannon, BA, MA, DClin
Chartered Clinical Psychologist (British Psychological Society)
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
- Doctoral Student in Educational, Child and Adolescent Psychology in Queen's University Belfast
Study Record Dates
First Submitted
November 29, 2011
First Posted
December 1, 2011
Study Start
May 1, 2011
Primary Completion
September 1, 2011
Study Completion
November 1, 2011
Last Updated
December 2, 2011
Record last verified: 2011-12