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Completed

NCT Number: NCT01494831

Randomized Control Trial of Group Intervention With Former War-affected Boys in the Democratic Republic of Congo

The purpose of this study is to evaluate, in a randomised control trial (RCT), the effectiveness of group-based, trauma-focused Cognitive Behaviour Therapy (TF-CBT) in reducing psychological distress in former child soldiers and other war-affected children in the Democratic Republic of Congo (DRC).

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Key information

Conditions

Post-traumatic Stress Disorder Attention Deficit and Disruptive Behavior Disorders Behavior Behavioral Symptoms Conduct Disorder Depression Mental Disorders Neurodevelopmental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

13 year–17 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

About this study

To the best of the author's knowledge this is the first group-based mental health or psychosocial intervention developed specifically for psychologically distressed former child soldiers. While CBT is the modality with most empirical evidence for treating war-affected young people, this is the first evaluation with child soldiers specifically.

Former child soldiers and war affected 'street boys' (aged 13-17) in eastern DRC, will be screened for symptoms of psychological distress and then randomly assigned to either a treatment group or a waiting-list control. The treatment groups will receive a 15-session manualised, culturally-adapted, TF-CBT intervention. This includes psycho-education, relaxation, affect modulation, cognitive processing and constructing a trauma narrative. After treatment and post-testing, the waiting-list controls then begin their intervention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • War-affected children and adolescents

Exclusion criteria

  • No traumatic war events experienced
  • Psychosis
  • Inability to speak Swahili, French or English

Treatment and study plan

TF-CBT

Behavioral

15 sessions of group-based, trauma-focused cognitive behavioral therapy

Other names: Trauma-focused Cognitive Behavioral Therapy

Primary outcomes

  1. Change in post-traumatic stress symptoms measured by UCLA-PTSD-RI

    Time frame: Post-intervention and 3 month

Secondary outcomes

  1. Change in psychosocial distress- measures by African Youth Psychosocial Assessment

    Time frame: Post-intervention and 3 month

    Psychosocial distress- depression, anxiety, conduct problems, antisocial behaviour

Sponsors and collaborators

Lead sponsor

Queen's University, Belfast

Other

Registry information

Official study title

Evaluation of a Group-based, Cognitive-behavioural Intervention With Former Child Soldiers and Other War-affected Children in the Democratic Republic of Congo: A Randomised Controlled Trial.

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 19, 2011
Registry last updated
Jan 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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