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N/A N=50 Randomized Double-blind Treatment

Psychological and Psychosocial Intervention With War-Affected Children

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

Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Change in Post-traumatic Stress Symptoms as Measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index — 47.77; 45.79; 21.54; 21.13 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Trauma Focused Cognitive Behavioral Therapy (Behavioral); Child Friendly Space (Behavioral)
Age
Pediatric, Adult · 7+ yrs
Sex
All
Sponsor
Queen's University, Belfast
Primary completion
Dec 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Post-traumatic Stress Symptoms as Measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index
47.77; 45.79; 21.54; 21.13; 18.42; 15.88
SECONDARY
Change in Internalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument
45.08; 44.83; 19.04; 16.63; 12.77; 12.46
SECONDARY
Change in Externalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument
13.88; 15.63; 5.35; 5.92; 4.35; 5.71
SECONDARY
Change in Pro-Social Behaviors as Measured by the African Youth Psychosocial Assessment Instrument
21.81; 22.96; 22.35; 23.33; 21.42; 18.75

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01509872). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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