Randomized Control Trial on Trauma Focused CBT in Zambia

NCT01624298 | Completed Results DMC

• 1 other identifier: TFCBTRCTDCOF
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post Traumatic Stress Disorder; Depression; Risk Behaviors

Keywords

Randomized controlled trial; Traumatized youth; HIV risk

Outcome Measures

Primary Outcomes (1)

• Post Traumatic Stress Disorder- Reaction Index (RI)

  The PTSD-RI assesses specific traumatic events a child has experienced or witnessed, and the associated mental health symptoms to such stressors. PTSD-RI can range from a score of 0 on the scale to a score of 4 on the scale. Higher scores are associated with greater symptomatology. The psychometric properties have been extensively demonstrated in the US and Internationally. The PTSD RI has also been translated into three local Zambian languages (Nyanja, Bemba and Tonga) and validated in Zambia in Johns Hopkins University faculty preliminary studies.

  Baseline and Follow-up within one month of treatment completion. For controls follow up was 4 months post baseline.

Secondary Outcomes (2)

• Risk Reduction as Assessed by the World AIDS Foundation (WAF) Risk Reduction Scale

  Baseline and follow-up within one month of treatment completion. For controls follow up was done 4 months post baseline.

• Child Behavior Checklist (CBCL) Score

  Baseline and follow-up within one month of treatment completion. For controls follow up was done 4 months post baseline.

Study Arms (2)

Wait List Control Group

NO INTERVENTION

The wait list control group will be asked to wait for approximately 4 1/2 months before being reassessed and then, unless found to be ineffective or harmful, receive the intervention being provided by the counselor.

Intervention Group

EXPERIMENTAL

Children randomized into the intervention group will immediately receive the Trauma Focused Cognitive Behavioral Therapy with a trained counselor for 12 weeks.

Behavioral: Trauma Focused Cognitive Behavioral Therapy

Interventions

Trauma Focused Cognitive Behavioral Therapy BEHAVIORAL

TF-CBT (www.musc.edu/tfcbt) is a therapy that helps children/youth ages 5-18 years and their families who have been affected by traumatic events and/or traumatic grief. Components include psychoeducation, relaxation, affective modulation, cognitive processing, Trauma Narrative (gradual exposure), In-vivo exposure, Con-joint session, and Enhancing safety skills. Youth and caregivers are seen once a week for approximately 12 weeks.

Also known as: TF-CBT

Intervention Group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead

Study Sites (1)

Serenity Harm Reduction Programme Zambia

Lusaka, 10101, Zambia

Location

Related Publications (1)

• Murray LK, Skavenski S, Kane JC, Mayeya J, Dorsey S, Cohen JA, Michalopoulos LT, Imasiku M, Bolton PA. Effectiveness of Trauma-Focused Cognitive Behavioral Therapy Among Trauma-Affected Children in Lusaka, Zambia: A Randomized Clinical Trial. JAMA Pediatr. 2015 Aug;169(8):761-9. doi: 10.1001/jamapediatrics.2015.0580.

  PMID: 26111066 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Risk-Taking

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Stephanie Skavenski
• Organization: Johns Hopkins University

sskavenski@yahoo.com

+260966674841

Study Officials

• Laura K Murray, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Paul Bolton, MBBS MPH

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2012
• First Posted: June 20, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-02

Locations

ZA (1)