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| Name | Class |
|---|---|
| Transcultural Psychosocial Organization Nepal | OTHER |
| UNICEF | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trauma-Focused Cognitive Behavioral Therapy | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trauma Focused Cognitive Behavioral Therapy | Behavioral | 9 sessions of manualised, culturally modified, group-based trauma-focused cognitive behavioral therapy |
|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Ciarán Shannon, BA, MA, DClin | British Psychological Society (Chartered Clinical Psychologist) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Child Friendly Space | Mwenga | South Kivu | Republic of the Congo |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | baseline, 3 week post-intervention and 6-month follow up |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Paul O'Callaghan | Queen's University Belfast | +44 7501 43 46 32 | pocallaghan02@qub.ac.uk |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| Child Friendly Space | Behavioral | 9 sessions of a manualised, culturally appropriate, non trauma-focused psychosocial intervention |
|
| baseline, 3 week post-intervention and 6 month follow up |
| 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 |
| 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 |
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | baseline, 3 week post-intervention and 6 month follow up |
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|
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| 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. | Posted | Mean | Standard Deviation | units on a scale | baseline, 3-week post-intervention, 6-month follow up |
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|
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| 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. | Posted | Mean | Standard Deviation | units on a scale | baseline, 3-week post-intervention, 6-month follow up |
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| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | 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 | 0 | 24 | 0 | 24 | 0 | 24 |
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| 6 month Follow-Up Intervention Scores |
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| 6 month Follow-Up Intervention Scores |
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| 6 month Follow-Up Intervention Scores |
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