An interventional study of Trauma Focused Cognitive Behavioral Therapy and Child Friendly Space in Stress Disorders, Post-Traumatic, Depression and Anxiety, sponsored by Queen's University, Belfast. Completed at 1 site in Congo. Open to participants aged 7 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-09.
Sponsored by Queen's University, Belfast · Not applicable, Interventional, and Treatment
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.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's enrollment of 50 is below the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →Queen's University, Belfast is the lead sponsor of 117 studies on the registry; 14 are open to participants now.
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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.
Behavioral: 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.
Behavioral: Child Friendly Space
9 sessions of manualised, culturally modified, group-based trauma-focused cognitive behavioral therapy
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, 3-week post-intervention, 6-month follow up
| Milestone | Trauma-Focused Cognitive Behavioral Therapy | A Child Friendly Space |
|---|---|---|
| Started | 26 | 24 |
| Post-intervention assessment | 26 | 24 |
| Completed | 25 | 24 |
| Not completed | 1 | 0 |
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.
| units on a scale | Trauma-Focused Cognitive Behavioral Therapy | A Child Friendly Space |
|---|---|---|
| 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 |
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.
| units on a scale | Trauma-Focused Cognitive Behavioral Therapy | A Child Friendly Space |
|---|---|---|
| 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 |
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.
| units on a scale | Trauma-Focused Cognitive Behavioral Therapy | A Child Friendly Space |
|---|---|---|
| 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 |
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.
| units on a scale | Trauma-Focused Cognitive Behavioral Therapy | A Child Friendly Space |
|---|---|---|
| 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 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Trauma-Focused Cognitive Behavioral Therapy | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| A Child Friendly Space | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Age, Continuous(years) | Trauma-Focused Cognitive Behavioral Therapy | A Child Friendly Space | Total |
|---|---|---|---|
| Mean | 14.77 ± 1.58 | 15.00 ± 1.64 | 14.88 ± 1.60 |
| Sex: Female, Male(Participants) | Trauma-Focused Cognitive Behavioral Therapy | A Child Friendly Space | Total |
|---|---|---|---|
| Female | 10 | 13 | 23 |
| Male | 16 | 11 | 27 |
| Region of Enrollment(participants) | Trauma-Focused Cognitive Behavioral Therapy | A Child Friendly Space | Total |
|---|---|---|---|
| Congo, The Democratic Republic of the | 26 | 24 | 50 |
The record gives a start of Oct 2011, a primary completion of Dec 2011 and a completion of Apr 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2019, 7 years 4 months after primary completion.
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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Stress Disorders, Post-Traumatic →