Psychological and Psychosocial Intervention With War-Affected Children

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01509872
• Other study ID #: PREC73-2011
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: April 2012

Study information

• Verified date: April 2019
• Source: Queen's University, Belfast
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Conduct
• Depression
• Pro-social Behavior
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Trauma Focused Cognitive Behavioral Therapy
9 sessions of manualised, culturally modified, group-based trauma-focused cognitive behavioral therapy
• Child Friendly Space
9 sessions of a manualised, culturally appropriate, non trauma-focused psychosocial intervention

Locations

Country	Name	City	State
Congo	Child Friendly Space	Mwenga	South Kivu

Sponsors (3)

Lead Sponsor	Collaborator
Queen's University, Belfast	Transcultural Psychosocial Organisation, UNICEF

Country where clinical trial is conducted

Congo, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Post-traumatic Stress Symptoms as Measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index	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	Change in Internalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument	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
Secondary	Change in Externalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument	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
Secondary	Change in Pro-Social Behaviors as Measured by the African Youth Psychosocial Assessment Instrument	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