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Trial record 3 of 30 for:    Diseases | ( Map: Congo )

Psychological and Psychosocial Intervention With War-Affected Children

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ClinicalTrials.gov Identifier: NCT01509872
Recruitment Status : Completed
First Posted : January 13, 2012
Results First Posted : April 9, 2019
Last Update Posted : April 9, 2019
Sponsor:
Collaborators:
Transcultural Psychosocial Organisation
UNICEF
Information provided by (Responsible Party):
Paul O'Callaghan, Queen's University, Belfast

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.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Depression Anxiety Conduct Pro-social Behavior Behavioral: Trauma Focused Cognitive Behavioral Therapy Behavioral: Child Friendly Space Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : October 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Trauma Focused Cognitive Behavioral Therapy
9 sessions of manualised, culturally modified, group-based trauma-focused cognitive behavioral therapy

Active Comparator: 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.
Behavioral: Child Friendly Space
9 sessions of a manualised, culturally appropriate, non trauma-focused psychosocial intervention




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509872


Locations
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Congo
Child Friendly Space
Mwenga, South Kivu, Congo
Sponsors and Collaborators
Queen's University, Belfast
Transcultural Psychosocial Organisation
UNICEF
Investigators
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Study Director: Dr Ciarán Shannon, BA, MA, DClin British Psychological Society (Chartered Clinical Psychologist)

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Responsible Party: Paul O'Callaghan, Principal Investigator, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT01509872     History of Changes
Other Study ID Numbers: PREC73-2011
First Posted: January 13, 2012    Key Record Dates
Results First Posted: April 9, 2019
Last Update Posted: April 9, 2019
Last Verified: April 2019

Keywords provided by Paul O'Callaghan, Queen's University, Belfast:
Trauma-Focused Cognitive Behavior Therapy
War-affected Children
Post-traumatic Stress Symptoms
Psychosocial Distress

Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders