Psychological and Psychosocial Intervention With War-Affected Children

NCT01509872 | Completed Results

• 1 other identifier: PREC73-2011
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-Traumatic; Depression; Anxiety; Conduct; Pro-social Behavior

Keywords

Trauma-Focused Cognitive Behavior Therapy; War-affected Children; Post-traumatic Stress Symptoms; Psychosocial Distress

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

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

  baseline, 3 week post-intervention and 6 month follow up

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

  baseline, 3-week post-intervention, 6-month follow up

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

  baseline, 3-week post-intervention, 6-month follow up

Study Arms (2)

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.

Behavioral: Trauma Focused Cognitive Behavioral Therapy

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.

Behavioral: Child Friendly Space

Interventions

Trauma Focused Cognitive Behavioral Therapy BEHAVIORAL

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

Trauma-Focused Cognitive Behavioral Therapy

Child Friendly Space BEHAVIORAL

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

A Child Friendly Space

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• psychosis,
• mental retardation,
• inability to understand Swahili,
• severe emotional \& behavioral problems that made group participation impossible

Sponsors & Collaborators

• Queen's University, Belfast: lead
• Transcultural Psychosocial Organization Nepal: collaborator
• UNICEF: collaborator

Study Sites (1)

Child Friendly Space

Mwenga, South Kivu, Republic of the Congo

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Anxiety Disorders; Behavior

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms

Results Point of Contact

• Title: Dr Paul O'Callaghan
• Organization: Queen's University Belfast

pocallaghan02@qub.ac.uk

+44 7501 43 46 32

Study Officials

• Dr Ciarán Shannon, BA, MA, DClin

  British Psychological Society (Chartered Clinical Psychologist)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 6, 2012
• First Posted: January 13, 2012
• Study Start: October 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: April 1, 2012
• Last Updated: April 9, 2019
• Results First Posted: April 9, 2019

Record last verified: 2019-04

Locations

RE (1)