This trial is active, not recruiting.

Conditions stress disorders, post-traumatic, depression, anxiety, conduct, pro-social behavior
Treatments trauma focused cognitive behavioral therapy, child friendly space
Phase phase 2
Sponsor Queen's University, Belfast
Collaborator Transcultural Psychosocial Organisation
Start date October 2011
End date December 2011
Trial size 50 participants
Trial identifier NCT01509872, PREC73-2011


The investigators are interested in knowing whether a group-based, trauma-focused intervention (Trauma Focused Cognitive Behavioral Therapy) is superior to a more general, non trauma-focused, psychosocial intervention (Child Friendly Spaces) in reducing post-traumatic stress, depression and anxiety and conduct problems and increasing pro-social behavior among war-affected children in the Democratic Republic of Congo.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (caregiver, outcomes assessor)
Primary purpose treatment
Trauma-Focused Cognitive Behaviour Therapy (Cohen, Mannarino, Deblinger, 2006; Smith and Saunders, 2005) is a child-friendly, manualised psychological intervention for children who experience nightmares, flashbacks, anxiety, anger, social isolation, poor concentration or self-blame after experiencing or witnessing a violent and terrifying life event (e.g. rape, murder, abduction etc). This intervention was culturally modified for use with war-affected children.
trauma focused cognitive behavioral therapy
9 sessions of manualised, culturally modified, group-based trauma-focused cognitive behavioral therapy
(Active Comparator)
A Child Friendly Space is a psychosocial intervention combining creative (e.g. art), imaginative (e.g. drama), physical (e.g. football), communicative (e.g. group discussions) and manipulative activities (e.g. story telling). It aids children's natural development by providing a safe place for children to learn, express themselves, grow and develop, supported by trained animators and peer educators.
child friendly space
9 sessions of a manualised, culturally appropriate, non trauma-focused psychosocial intervention

Primary Outcomes

Change in Post-traumatic Stress Symptoms as measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index
time frame: baseline, 3 week post-intervention and 3-months

Secondary Outcomes

Change in Psychosocial Distress as measured by the African Youth Psychosocial Assessment Instrument
time frame: baseline, 3 week post-intervention and 3-months

Eligibility Criteria

Male or female participants from 7 years up to 18 years old.

Inclusion Criteria: - under 18 years of age, - witness to a violent event involving a real or perceived direct threat to life, - ability to attend a 3-week intervention Exclusion Criteria: - psychosis, - mental retardation, - inability to understand Swahili, - severe emotional & behavioral problems that made group participation impossible

Additional Information

Official title An RCT Comparing Trauma-Focused Cognitive Behavioral Therapy (a Specific Psychological Intervention) and A Child Friendly Space (a Non-trauma Focused Psychosocial Intervention) in Reducing Psychological Distress Among War-affected Children
Trial information was received from ClinicalTrials.gov and was last updated in January 2012.
Information provided to ClinicalTrials.gov by Queen's University, Belfast.