Psychological and Psychosocial Intervention With War-Affected Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01509872
Recruitment Status : Unknown
Verified January 2012 by Paul O'Callaghan, Queen's University, Belfast.
Recruitment status was:  Active, not recruiting
First Posted : January 13, 2012
Last Update Posted : January 13, 2012
Transcultural Psychosocial Organisation
Information provided by (Responsible Party):
Paul O'Callaghan, Queen's University, Belfast

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Depression Anxiety Conduct Pro-social Behavior Behavioral: Trauma Focused Cognitive Behavioral Therapy Behavioral: Child Friendly Space Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2011
Actual Primary Completion Date : December 2011
Estimated Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Trauma-Focused Cognitive Behavioral Therapy
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.
Behavioral: Trauma Focused Cognitive Behavioral Therapy
9 sessions of manualised, culturally modified, group-based trauma-focused cognitive behavioral therapy

Active Comparator: A Child Friendly Space
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.
Behavioral: Child Friendly Space
9 sessions of a manualised, culturally appropriate, non trauma-focused psychosocial intervention

Primary Outcome Measures :
  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, 3 week post-intervention and 3-months ]

Secondary Outcome Measures :
  1. Change in Psychosocial Distress as measured by the African Youth Psychosocial Assessment Instrument [ Time Frame: baseline, 3 week post-intervention and 3-months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01509872

Child Friendly Space
Tuseswa, Mwenga, South Kivu, Congo
Sponsors and Collaborators
Queen's University, Belfast
Transcultural Psychosocial Organisation
Study Director: Dr Ciarán Shannon, BA, MA, DClin British Psychological Society (Chartered Clinical Psychologist)

Responsible Party: Paul O'Callaghan, Principal Investigator, Queen's University, Belfast Identifier: NCT01509872     History of Changes
Other Study ID Numbers: PREC73-2011
First Posted: January 13, 2012    Key Record Dates
Last Update Posted: January 13, 2012
Last Verified: January 2012

Keywords provided by Paul O'Callaghan, Queen's University, Belfast:
Trauma-Focused Cognitive Behavior Therapy
War-affected Children
Post-traumatic Stress Symptoms
Psychosocial Distress

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders