- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01483261
An RCT of Trauma Focused-Cognitive Behavioral Therapy With Sexually Exploited, War-affected Girls in the DRC
December 1, 2011 updated by: Paul O'Callaghan, Queen's University, Belfast
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.
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Kivu
-
Beni, South Kivu, Congo
- World Vision Rebound Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
-Suicidal ideation (irrespective of score on any other measure)
Exclusion Criteria:
- psychosis
- mental retardation
- inability to understand Swahili
- one standard deviation below the mean on every measure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Trauma-Focused Cognitive Behavioral Therapy
|
15 sessions of manualised, culturally modified trauma-focused cognitive behavior therapy
|
No Intervention: Waiting List Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Post-traumatic Stress Symptoms as measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index
Time Frame: baseline, post-intervention and 3-months
|
baseline, post-intervention and 3-months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Psychosocial Distress as measured by the African Youth Psychosocial Assessment Instrument
Time Frame: baseline post-intervention and 3-months
|
baseline post-intervention and 3-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Dr Ciaran Shannon, BA, MA, DClin, Chartered Clinical Psychologist (British Psychological Society)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
November 29, 2011
First Submitted That Met QC Criteria
November 29, 2011
First Posted (Estimate)
December 1, 2011
Study Record Updates
Last Update Posted (Estimate)
December 2, 2011
Last Update Submitted That Met QC Criteria
December 1, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PREC23-2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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