An RCT of Trauma Focused-Cognitive Behavioral Therapy With Sexually Exploited, War-affected Girls in the DRC

This study has been completed.
Sponsor:
Collaborator:
World Vision
Information provided by (Responsible Party):
Paul O'Callaghan, Queen's University, Belfast
ClinicalTrials.gov Identifier:
NCT01483261
First received: November 29, 2011
Last updated: December 1, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Post-traumatic Stress Symptoms
Psychosocial Distress
Behavioral: Trauma-Focused Cognitive Behavioral Therapy
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: 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.

Resource links provided by NLM:


Further study details as provided by Queen's University, Belfast:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Psychosocial Distress as measured by the African Youth Psychosocial Assessment Instrument [ Time Frame: baseline post-intervention and 3-months ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: May 2011
Study Completion Date: November 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trauma-Focused Cognitive Behavioral Therapy Behavioral: Trauma-Focused Cognitive Behavioral Therapy
15 sessions of manualised, culturally modified trauma-focused cognitive behavior therapy
No Intervention: Waiting List Control

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01483261

Locations
Congo
World Vision Rebound Centre
Beni, South Kivu, Congo
Sponsors and Collaborators
Queen's University, Belfast
World Vision
Investigators
Study Director: Dr Ciaran Shannon, BA, MA, DClin Chartered Clinical Psychologist (British Psychological Society)
  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: Paul O'Callaghan, Doctoral Student in Educational, Child and Adolescent Psychology in Queen's University Belfast, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT01483261     History of Changes
Other Study ID Numbers: PREC23-2011
Study First Received: November 29, 2011
Last Updated: December 1, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Queen's University, Belfast:
Trauma-Focused Cognitive Behavior Therapy
Sexually Exploited Girls
Post-traumatic Stress Symptoms
Psychosocial Distress

ClinicalTrials.gov processed this record on July 26, 2014