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Psychological and Psychosocial Intervention With War-Affected Children

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Transcultural Psychosocial Organisation
UNICEF
Information provided by (Responsible Party):
Paul O'Callaghan, Queen's University, Belfast
ClinicalTrials.gov Identifier:
NCT01509872
First received: January 6, 2012
Last updated: January 10, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention Phase
Stress Disorders, Post-Traumatic
Depression
Anxiety
Conduct
Pro-social Behavior
 Behavioral: Trauma Focused Cognitive Behavioral Therapy
Behavioral: Child Friendly Space
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Queen's University, Belfast:

Primary Outcome Measures:
  • 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 3-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Psychosocial Distress as measured by the African Youth Psychosocial Assessment Instrument [ Time Frame: baseline, 3 week post-intervention and 3-months ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: October 2011
Estimated Study Completion Date: April 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509872

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

No publications provided

Responsible Party: Paul O'Callaghan, Principal Investigator, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT01509872     History of Changes
Other Study ID Numbers: PREC73-2011
Study First Received: January 6, 2012
Last Updated: January 10, 2012
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Stress Disorders, Post-Traumatic
 Stress Disorders, Traumatic
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on May 23, 2013