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

NCT ID: NCT01483261

Last Updated: 2011-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Post-traumatic Stress Symptoms Psychosocial Distress

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Trauma-Focused Cognitive Behavioral Therapy

Group Type EXPERIMENTAL

Trauma-Focused Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

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

Waiting List Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Trauma-Focused Cognitive Behavioral Therapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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World Vision

OTHER

Sponsor Role collaborator

Queen's University, Belfast

OTHER

Sponsor Role lead

Responsible Party

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Paul O'Callaghan

Doctoral Student in Educational, Child and Adolescent Psychology in Queen's University Belfast

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr Ciaran Shannon, BA, MA, DClin

Role: STUDY_DIRECTOR

Chartered Clinical Psychologist (British Psychological Society)

Locations

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World Vision Rebound Centre

Beni, South Kivu, Republic of the Congo

Site Status

Countries

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Republic of the Congo

References

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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.

Reference Type DERIVED
PMID: 23582867 (View on PubMed)

Other Identifiers

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PREC23-2011

Identifier Type: -

Identifier Source: org_study_id