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Psychological and Psychosocial Intervention With War-Affected Children

Primary Purpose

Stress Disorders, Post-Traumatic, Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Congo
Study Type
Interventional
Intervention
Trauma Focused Cognitive Behavioral Therapy
Child Friendly Space
Sponsored by
Queen's University, Belfast
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Trauma-Focused Cognitive Behavior Therapy, War-affected Children, Post-traumatic Stress Symptoms, Psychosocial Distress

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Child Friendly Space

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Trauma-Focused Cognitive Behavioral Therapy

A Child Friendly Space

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 6, 2012
Last Updated
April 6, 2019
Sponsor
Queen's University, Belfast
Collaborators
Transcultural Psychosocial Organization Nepal, UNICEF
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1. Study Identification

Unique Protocol Identification Number
NCT01509872
Brief Title
Psychological and Psychosocial Intervention With War-Affected Children
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 Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University, Belfast
Collaborators
Transcultural Psychosocial Organization Nepal, UNICEF

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Depression, Anxiety, Conduct, Pro-social Behavior
Keywords
Trauma-Focused Cognitive Behavior Therapy, War-affected Children, Post-traumatic Stress Symptoms, Psychosocial Distress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trauma-Focused Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
A Child Friendly Space
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Trauma Focused Cognitive Behavioral Therapy
Intervention Description
9 sessions of manualised, culturally modified, group-based trauma-focused cognitive behavioral therapy
Intervention Type
Behavioral
Intervention Name(s)
Child Friendly Space
Intervention Description
9 sessions of a manualised, culturally appropriate, non trauma-focused psychosocial intervention
Primary Outcome Measure Information:
Title
Change in Post-traumatic Stress Symptoms as Measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index
Description
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.
Time Frame
baseline, 3 week post-intervention and 6-month follow up
Secondary Outcome Measure Information:
Title
Change in Internalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument
Description
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.
Time Frame
baseline, 3 week post-intervention and 6 month follow up
Title
Change in Externalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument
Description
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.
Time Frame
baseline, 3-week post-intervention, 6-month follow up
Title
Change in Pro-Social Behaviors as Measured by the African Youth Psychosocial Assessment Instrument
Description
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.
Time Frame
baseline, 3-week post-intervention, 6-month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Ciarán Shannon, BA, MA, DClin
Organizational Affiliation
British Psychological Society (Chartered Clinical Psychologist)
Official's Role
Study Director
Facility Information:
Facility Name
Child Friendly Space
City
Mwenga
State/Province
South Kivu
Country
Congo

12. IPD Sharing Statement

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Psychological and Psychosocial Intervention With War-Affected Children

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