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CompletedNCT01483261Updated Dec 2, 2011

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

A Phase 2 interventional study of Trauma-Focused Cognitive Behavioral Therapy in Post-traumatic Stress Symptoms and Psychosocial Distress, sponsored by Queen's University, Belfast. Completed at 1 site in Congo. Open to female participants aged 10 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-12-02.

Sponsored by Queen's University, Belfast · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
10 Years to 18 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Post-traumatic Stress Symptoms
  • Psychosocial Distress

Keywords

  • Trauma-Focused Cognitive Behavior Therapy
  • Sexually Exploited Girls
  • Post-traumatic Stress Symptoms
  • Psychosocial Distress
03

In context

Lead sponsor

Queen's University, Belfast is the lead sponsor of 117 studies on the registry; 14 are open to participants now.

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04

Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

-Suicidal ideation (irrespective of score on any other measure)

Exclusion criteria

Exclusion Criteria:

  • psychosis
  • mental retardation
  • inability to understand Swahili
  • one standard deviation below the mean on every measure
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Trauma-Focused Cognitive Behavioral Therapy

    Behavioral: Trauma-Focused Cognitive Behavioral Therapy

  • No intervention
    Waiting List Control

Interventions

  • BehavioralTrauma-Focused Cognitive Behavioral Therapy

    15 sessions of manualised, culturally modified trauma-focused cognitive behavior therapy

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in Psychosocial Distress as measured by the African Youth Psychosocial Assessment Instrument

    Time frame: baseline post-intervention and 3-months

07

Study locations

1 site
  • World Vision Rebound Centre
    Beni, South Kivu, Congo
08

References and documents

Publications

  • 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. PubMed 23582867 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01483261
Lead sponsor
Queen's University, Belfast
Collaborators
World Vision
Responsible party
Paul O'Callaghan (Doctoral Student in Educational, Child and Adolescent Psychology in Queen's University Belfast, Queen's University, Belfast) — Principal investigator
First posted
Dec 1, 2011
Start date
May 2011
Primary completion
Sep 2011
Completion
Nov 2011
Last update
Dec 2, 2011

Study contacts

Dr Ciaran Shannon, BA, MA, DClin
study director · Chartered Clinical Psychologist (British Psychological Society)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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