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Completed

NCT Number: NCT01509872

Psychological and Psychosocial Intervention With War-Affected Children

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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Key information

Conditions

Stress Disorders, Post-Traumatic Anxiety Anxiety Disorders Behavior Behavioral Symptoms Conduct Depression Mental Disorders Pro-social Behavior Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Child Friendly Space

Mwenga, South Kivu, Republic of the Congo

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trauma Focused Cognitive Behavioral Therapy

Behavioral

9 sessions of manualised, culturally modified, group-based trauma-focused cognitive behavioral therapy

Child Friendly Space

Behavioral

9 sessions of a manualised, culturally appropriate, non trauma-focused psychosocial intervention

Primary outcomes

  1. Change in Post-traumatic Stress Symptoms as Measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index

    Time frame: 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 outcomes

  1. Change in Internalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument

    Time frame: 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.

  2. Change in Externalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument

    Time frame: 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.

  3. Change in Pro-Social Behaviors as Measured by the African Youth Psychosocial Assessment Instrument

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Queen's University, Belfast

Other

Collaborators

  • Transcultural Psychosocial Organization Nepal
  • UNICEF

Registry information

Official study title

An RCT Comparing Trauma-Focused Cognitive Behavioral Therapy (a Specific Psychological Intervention) and A Child Friendly Space (a Non-trauma Focused Psychosocial Intervention) in Reducing Psychological Distress Among War-affected Children

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Jan 13, 2012
Registry last updated
Apr 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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