Anxiety, Conduct, Depression, Pro-social Behavior, Stress Disorders, Post-Traumatic
Conditions
Keywords
Trauma-Focused Cognitive Behavior Therapy, War-affected Children, Post-traumatic Stress Symptoms, Psychosocial Distress
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.
Interventions
9 sessions of manualised, culturally modified, group-based trauma-focused cognitive behavioral therapy
BEHAVIORALChild Friendly Space
9 sessions of a manualised, culturally appropriate, non trauma-focused psychosocial intervention
Sponsors
Transcultural Psychosocial Organization Nepal
UNICEF
Queen's University, Belfast
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Post-traumatic Stress Symptoms as Measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Internalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument | 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. |
| Change in Externalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument | 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. |
| Change in Pro-Social Behaviors as Measured by the African Youth Psychosocial Assessment Instrument | 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. |
Countries
Republic of the Congo
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 26 |
| 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 | 24 |
| Total | 50 |
Baseline characteristics
| Characteristic | Trauma-Focused Cognitive Behavioral Therapy | A Child Friendly Space | Total |
|---|---|---|---|
| Age, Continuous | 14.77 years STANDARD_DEVIATION 1.58 | 15.00 years STANDARD_DEVIATION 1.64 | 14.88 years STANDARD_DEVIATION 1.6 |
| Region of Enrollment Congo, The Democratic Republic of the | 26 participants | 24 participants | 50 participants |
| Sex: Female, Male Female | 10 Participants | 13 Participants | 23 Participants |
| Sex: Female, Male Male | 16 Participants | 11 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 24 |
| other Total, other adverse events | 0 / 26 | 0 / 24 |
| serious Total, serious adverse events | 0 / 26 | 0 / 24 |
Outcome results
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.
Time frame: baseline, 3 week post-intervention and 6-month follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trauma-Focused Cognitive Behavioral Therapy | 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 |
| Trauma-Focused Cognitive Behavioral Therapy | 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 |
| Trauma-Focused Cognitive Behavioral Therapy | 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 |
| A Child Friendly Space | Change in Post-traumatic Stress Symptoms as Measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index | Pre-Intervention Scores | 45.79 units on a scale | Standard Deviation 6.87 |
| A Child Friendly Space | Change in Post-traumatic Stress Symptoms as Measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index | Post-Intervention Scores | 21.13 units on a scale | Standard Deviation 6.95 |
| A Child Friendly Space | 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 | 15.88 units on a scale | Standard Deviation 7.03 |
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.
Time frame: baseline, 3-week post-intervention, 6-month follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trauma-Focused Cognitive Behavioral Therapy | 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 |
| Trauma-Focused Cognitive Behavioral Therapy | Change in Externalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument | Post-Intervention Scores | 5.35 units on a scale | Standard Deviation 4.2 |
| Trauma-Focused Cognitive Behavioral Therapy | 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 |
| A Child Friendly Space | Change in Externalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument | Pre-Intervention Scores | 15.63 units on a scale | Standard Deviation 6.54 |
| A Child Friendly Space | Change in Externalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument | Post-Intervention Scores | 5.92 units on a scale | Standard Deviation 4.41 |
| A Child Friendly Space | Change in Externalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument | 6 month Follow-Up Intervention Scores | 5.71 units on a scale | Standard Deviation 5.39 |
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.
Time frame: baseline, 3 week post-intervention and 6 month follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trauma-Focused Cognitive Behavioral Therapy | 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 |
| Trauma-Focused Cognitive Behavioral Therapy | 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 |
| Trauma-Focused Cognitive Behavioral Therapy | 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 |
| A Child Friendly Space | Change in Internalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument | Pre-Intervention Scores | 44.83 units on a scale | Standard Deviation 9.25 |
| A Child Friendly Space | Change in Internalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument | Post-Intervention Scores | 16.63 units on a scale | Standard Deviation 9.36 |
| A Child Friendly Space | Change in Internalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument | 6 month Follow-Up Intervention Scores | 12.46 units on a scale | Standard Deviation 8.54 |
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.
Time frame: baseline, 3-week post-intervention, 6-month follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trauma-Focused Cognitive Behavioral Therapy | 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 |
| Trauma-Focused Cognitive Behavioral Therapy | 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 |
| Trauma-Focused Cognitive Behavioral Therapy | 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 |
| A Child Friendly Space | Change in Pro-Social Behaviors as Measured by the African Youth Psychosocial Assessment Instrument | Pre-Intervention Scores | 22.96 units on a scale | Standard Deviation 5.84 |
| A Child Friendly Space | Change in Pro-Social Behaviors as Measured by the African Youth Psychosocial Assessment Instrument | Post-Intervention Scores | 23.33 units on a scale | Standard Deviation 4.16 |
| A Child Friendly Space | Change in Pro-Social Behaviors as Measured by the African Youth Psychosocial Assessment Instrument | 6 month Follow-Up Intervention Scores | 18.75 units on a scale | Standard Deviation 5.19 |