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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

January 6, 2012
January 10, 2012
October 2011
December 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01509872 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Psychological and Psychosocial Intervention With War-Affected Children
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
  • Stress Disorders, Post-Traumatic
  • Depression
  • Anxiety
  • Conduct
  • Pro-social Behavior
  • Behavioral: Trauma Focused Cognitive Behavioral Therapy
    9 sessions of manualised, culturally modified, group-based trauma-focused cognitive behavioral therapy
  • Behavioral: Child Friendly Space
    9 sessions of a manualised, culturally appropriate, non trauma-focused psychosocial intervention
  • 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.
    Intervention: Behavioral: 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.
    Intervention: Behavioral: Child Friendly Space
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
April 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
7 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Congo
 
NCT01509872
PREC73-2011
No
Paul O'Callaghan, Queen's University, Belfast
Queen's University, Belfast
  • Transcultural Psychosocial Organisation
  • UNICEF
Study Director: Dr Ciarán Shannon, BA, MA, DClin British Psychological Society (Chartered Clinical Psychologist)
Queen's University, Belfast
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP