Psychological and Psychosocial Intervention With War-Affected Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Queen's University, Belfast.
Recruitment status was  Active, not recruiting
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
  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:


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 April 17, 2014