Trial Outcomes & Findings for Psychological and Psychosocial Intervention With War-Affected Children (NCT NCT01509872)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

baseline, 3 week post-intervention and 6-month follow up

Results posted on

2019-04-09

Participant Flow

Participant milestones

Participant milestones
Measure	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. Trauma Focused Cognitive Behavioral Therapy: 9 sessions of manualised, culturally modified, group-based trauma-focused cognitive behavioral therapy	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. Child Friendly Space: 9 sessions of a manualised, culturally appropriate, non trauma-focused psychosocial intervention
Overall Study STARTED	26	24
Overall Study Post-Intervention Assessment	26	24
Overall Study COMPLETED	25	24
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Psychological and Psychosocial Intervention With War-Affected Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trauma-Focused Cognitive Behavioral Therapy n=26 Participants 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 n=24 Participants 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 n=50 Participants Total of all reporting groups
Age, Continuous	14.77 years STANDARD_DEVIATION 1.58 • n=5 Participants	15.00 years STANDARD_DEVIATION 1.64 • n=7 Participants	14.88 years STANDARD_DEVIATION 1.60 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	11 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment Congo, The Democratic Republic of the	26 participants n=5 Participants	24 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Trauma-Focused Cognitive Behavioral Therapy n=26 Participants 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 n=24 Participants 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
Change in Post-traumatic Stress Symptoms as Measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index Pre-Intervention Scores	47.77 units on a scale Standard Deviation 6.62	45.79 units on a scale Standard Deviation 6.87
Change in Post-traumatic Stress Symptoms as Measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index Post-Intervention Scores	21.54 units on a scale Standard Deviation 10.13	21.13 units on a scale Standard Deviation 6.95
Change in Post-traumatic Stress Symptoms as Measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index 6 month Follow-Up Intervention Scores	18.42 units on a scale Standard Deviation 6.17	15.88 units on a scale Standard Deviation 7.03

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Trauma-Focused Cognitive Behavioral Therapy n=26 Participants 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 n=24 Participants 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
Change in Internalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument Pre-Intervention Scores	45.08 units on a scale Standard Deviation 11.26	44.83 units on a scale Standard Deviation 9.25
Change in Internalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument Post-Intervention Scores	19.04 units on a scale Standard Deviation 15.09	16.63 units on a scale Standard Deviation 9.36
Change in Internalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument 6 month Follow-Up Intervention Scores	12.77 units on a scale Standard Deviation 9.32	12.46 units on a scale Standard Deviation 8.54

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Trauma-Focused Cognitive Behavioral Therapy n=26 Participants 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 n=24 Participants 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
Change in Externalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument Pre-Intervention Scores	13.88 units on a scale Standard Deviation 6.89	15.63 units on a scale Standard Deviation 6.54
Change in Externalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument Post-Intervention Scores	5.35 units on a scale Standard Deviation 4.20	5.92 units on a scale Standard Deviation 4.41
Change in Externalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument 6 month Follow-Up Intervention Scores	4.35 units on a scale Standard Deviation 3.61	5.71 units on a scale Standard Deviation 5.39

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Trauma-Focused Cognitive Behavioral Therapy n=26 Participants 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 n=24 Participants 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
Change in Pro-Social Behaviors as Measured by the African Youth Psychosocial Assessment Instrument Pre-Intervention Scores	21.81 units on a scale Standard Deviation 5.84	22.96 units on a scale Standard Deviation 5.84
Change in Pro-Social Behaviors as Measured by the African Youth Psychosocial Assessment Instrument Post-Intervention Scores	22.35 units on a scale Standard Deviation 3.86	23.33 units on a scale Standard Deviation 4.16
Change in Pro-Social Behaviors as Measured by the African Youth Psychosocial Assessment Instrument 6 month Follow-Up Intervention Scores	21.42 units on a scale Standard Deviation 4.24	18.75 units on a scale Standard Deviation 5.19

Adverse Events

Trauma-Focused Cognitive Behavioral Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

A Child Friendly Space

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Paul O'Callaghan

Queen's University Belfast

Phone: +44 7501 43 46 32

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place