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Trial record 3 of 30 for:    Diseases | ( Map: Congo )

Psychological and Psychosocial Intervention With War-Affected Children

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ClinicalTrials.gov Identifier: NCT01509872
Recruitment Status : Completed
First Posted : January 13, 2012
Results First Posted : April 9, 2019
Last Update Posted : April 9, 2019
Sponsor:
Collaborators:
Transcultural Psychosocial Organisation
UNICEF
Information provided by (Responsible Party):
Paul O'Callaghan, Queen's University, Belfast

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Stress Disorders, Post-Traumatic
Depression
Anxiety
Conduct
Pro-social Behavior
Interventions Behavioral: Trauma Focused Cognitive Behavioral Therapy
Behavioral: Child Friendly Space
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Trauma-Focused Cognitive Behavioral Therapy A Child Friendly Space
Hide Arm/Group 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.

Trauma Focused Cognitive Behavioral Therapy: 9 sessions of manualised, culturally modified, group-based trauma-focused cognitive behavioral therapy

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

Period Title: Overall Study
Started 26 24
Post-Intervention Assessment 26 24
Completed 25 24
Not Completed 1 0
Arm/Group Title Trauma-Focused Cognitive Behavioral Therapy A Child Friendly Space Total
Hide Arm/Group 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.

Trauma Focused Cognitive Behavioral Therapy: 9 sessions of manualised, culturally modified, group-based trauma-focused cognitive behavioral therapy

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

Total of all reporting groups
Overall Number of Baseline Participants 26 24 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 24 participants 50 participants
14.77  (1.58) 15.00  (1.64) 14.88  (1.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 24 participants 50 participants
Female
10
  38.5%
13
  54.2%
23
  46.0%
Male
16
  61.5%
11
  45.8%
27
  54.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Congo, The Democratic Republic of the Number Analyzed 26 participants 24 participants 50 participants
26 24 50
1.Primary Outcome
Title Change in Post-traumatic Stress Symptoms as Measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trauma-Focused Cognitive Behavioral Therapy A Child Friendly Space
Hide Arm/Group 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.

Trauma Focused Cognitive Behavioral Therapy: 9 sessions of manualised, culturally modified, group-based trauma-focused cognitive behavioral therapy

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

Overall Number of Participants Analyzed 26 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-Intervention Scores 47.77  (6.62) 45.79  (6.87)
Post-Intervention Scores 21.54  (10.13) 21.13  (6.95)
6 month Follow-Up Intervention Scores 18.42  (6.17) 15.88  (7.03)
2.Secondary Outcome
Title Change in Internalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trauma-Focused Cognitive Behavioral Therapy A Child Friendly Space
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 26 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-Intervention Scores 45.08  (11.26) 44.83  (9.25)
Post-Intervention Scores 19.04  (15.09) 16.63  (9.36)
6 month Follow-Up Intervention Scores 12.77  (9.32) 12.46  (8.54)
3.Secondary Outcome
Title Change in Externalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trauma-Focused Cognitive Behavioral Therapy A Child Friendly Space
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 26 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-Intervention Scores 13.88  (6.89) 15.63  (6.54)
Post-Intervention Scores 5.35  (4.20) 5.92  (4.41)
6 month Follow-Up Intervention Scores 4.35  (3.61) 5.71  (5.39)
4.Secondary Outcome
Title Change in Pro-Social Behaviors as Measured by the African Youth Psychosocial Assessment Instrument
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trauma-Focused Cognitive Behavioral Therapy A Child Friendly Space
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 26 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-Intervention Scores 21.81  (5.84) 22.96  (5.84)
Post-Intervention Scores 22.35  (3.86) 23.33  (4.16)
6 month Follow-Up Intervention Scores 21.42  (4.24) 18.75  (5.19)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Trauma-Focused Cognitive Behavioral Therapy A Child Friendly Space
Hide Arm/Group 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.

Trauma Focused Cognitive Behavioral Therapy: 9 sessions of manualised, culturally modified, group-based trauma-focused cognitive behavioral therapy

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

All-Cause Mortality
Trauma-Focused Cognitive Behavioral Therapy A Child Friendly Space
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/24 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Trauma-Focused Cognitive Behavioral Therapy A Child Friendly Space
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Trauma-Focused Cognitive Behavioral Therapy A Child Friendly Space
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/24 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr Paul O'Callaghan
Organization: Queen's University Belfast
Phone: +44 7501 43 46 32
Responsible Party: Paul O'Callaghan, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT01509872     History of Changes
Other Study ID Numbers: PREC73-2011
First Submitted: January 6, 2012
First Posted: January 13, 2012
Results First Submitted: October 22, 2014
Results First Posted: April 9, 2019
Last Update Posted: April 9, 2019