N/A
N=257
Randomized Control Trial on Trauma Focused CBT in Zambia
Post Traumatic Stress Disorder · Depression · Risk Behaviors
Bottom Line
View on ClinicalTrials.gov: NCT01624298 ↗Enrolled (actual)
257
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Post Traumatic Stress Disorder- Reaction Index (RI) — 1.75; 1.88; 1.38; 0.34 trauma score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Trauma Focused Cognitive Behavioral Therapy (Behavioral)
- Age
- Pediatric, Adult · 5+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post Traumatic Stress Disorder- Reaction Index (RI) |
1.75; 1.88; 1.38; 0.34 | — |
| SECONDARY Risk Reduction as Assessed by the World AIDS Foundation (WAF) Risk Reduction Scale |
0.7; 0.9; 0.8; 0.2 | — |
| SECONDARY Child Behavior Checklist (CBCL) Score |
36.8; 77.8; 2.4; 15.8 | — |
Summary
The purpose of this study is to study the effectiveness of Trauma Focused Cognitive Behavioral Therapy in subset of children who are affected by trauma with significant mental health symptomatology in order to 1) examine the effectiveness of TF-CBT in reducing the severity of mental health symptoms experienced by traumatized children and adolescents in Lusaka and 2) determine the effectiveness of TF-CBT in reducing HIV risk taking behaviors and increasing coping strategies and health promotion activities in traumatized children and adolescents in Lusaka. The study will be integrated into current programing of the Serenity Harm Reduction Programme, a community and faith based organization focusing on mental health and substance use prevention and treatment, and its partners in 5 compounds.
Eligibility Criteria
Inclusion Criteria
- Youth found to exhibit significant trauma symptomatology as evidenced by a score of 38 or above on the previously validated PTSD-RI symptom scale (Murray, et al. 2011) (trauma severity is the main study outcome) will be invited to join the trial. Youth must live in Lusaka, Zambia.
Exclusion Criteria
- Youth currently receiving psychiatric care
- Youth who are actively suicidal
- Persons who are not mentally competent to give assent or whose legal guardians are not mentally competent to give consent to participate in the intervention
Data sourced from ClinicalTrials.gov (NCT01624298). 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.