- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01509872
Psychological and Psychosocial Intervention With War-Affected Children
April 6, 2019 updated by: Paul O'Callaghan, Queen's University, Belfast
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Kivu
-
Mwenga, South Kivu, Congo
- Child Friendly Space
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / 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.
|
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.
|
9 sessions of a manualised, culturally appropriate, non trauma-focused psychosocial intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 6-month follow up
|
The UCLA PTSD Reaction Index is a self-report questionnaire that measures exposure to traumatic events and assesses post-tramatic stress symptoms in school-age children and adolescents.
The Congolese Swahili version used in the study had 22 items and assesses the frequency of occurrence of PTSD symptoms during the past week (rated from 0 = none of the time to 4 = most of the time).
The scale ranged from 0 (no symptoms) to 88 (highest score possible).
Although no cut-off score was used, the higher the score of the scale the higher the number of PTSD symptoms experienced.
|
baseline, 3 week post-intervention and 6-month follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Internalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument
Time Frame: baseline, 3 week post-intervention and 6 month follow up
|
The African Youth Psychosocial Assessment Instrument is a self-report questionnaire that measures internalizing, externalizing, conduct and pro-social (daily life functioning) skills symptoms.
The Congolese Swahili version of the AYPA contained 19 questions on internalizing symptoms and assesses the frequency of occurrence of internalizing symptoms during the past week (rated from 0 = none of the time to 4 = most of the time).
The lowest score obtainable on the measure was 0, while the highest score obtainable was 76.
Although no cut-off score was used, the higher the score on the scale, the greater the psychosocial distress being reported.
|
baseline, 3 week post-intervention and 6 month follow up
|
Change in Externalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument
Time Frame: baseline, 3-week post-intervention, 6-month follow up
|
The African Youth Psychosocial Assessment Instrument is a self-report questionnaire that measures internalizing, externalizing, conduct and pro-social (daily life functioning) skills symptoms.
The Congolese Swahili version of the AYPA contained 10 questions about symptoms of conduct disorder and assesses the frequency of occurrence of externalizing symptoms during the past week (rated from 0 = none of the time to 4 = most of the time).
The lowest score obtainable on the measure was 0, while the highest score obtainable was 40.
Although no cut-off score was used, the higher the score on the scale, the greater the psychosocial adjustment difficulties being reported.
|
baseline, 3-week post-intervention, 6-month follow up
|
Change in Pro-Social Behaviors as Measured by the African Youth Psychosocial Assessment Instrument
Time Frame: baseline, 3-week post-intervention, 6-month follow up
|
The African Youth Psychosocial Assessment Instrument is a self-report questionnaire that measures internalizing, externalizing, conduct and pro-social (daily life functioning) skills symptoms.
The Congolese Swahili version of the AYPA contained 8 questions about pro-social behavior and assesses the frequency of occurrence of positive behaviors (e.g.
sharing with others, listening to others and elders etc.) during the past week (rated from 0 = none of the time to 4 = most of the time).
The lowest score obtainable on the measure was 0, while the highest score obtainable was 32.
Although no cut-off score was used, the higher the score on the scale, the more pro-social the individual's behavior is.
|
baseline, 3-week post-intervention, 6-month follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Dr Ciarán Shannon, BA, MA, DClin, British Psychological Society (Chartered Clinical Psychologist)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
January 6, 2012
First Submitted That Met QC Criteria
January 10, 2012
First Posted (Estimate)
January 13, 2012
Study Record Updates
Last Update Posted (Actual)
April 9, 2019
Last Update Submitted That Met QC Criteria
April 6, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PREC73-2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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