Clinical trial NCT01624298: Randomized Control Trial on Trauma Focused CBT in Zambia
Official title: A Randomized Control Trial to Determine the Effectiveness of Trauma Focused Cognitive Behavioral (TF-CBT) Among Children in Lusaka, Zambia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Depression
Risk Behaviors
Keywords: Randomized controlled trial
Traumatized youth
HIV risk
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2012-06-20
Enrollment: 257
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: In preparation for the trial, in February and March of 2012, a US-based clinical psychologist and expert trainer in TF-CBT traveled to Lusaka Zambia and trained 20 counselors in TF-CBT. This included supplemental training of the already established and trained national TF-CBT supervisors from SHARPZ and the University of Zambia (UNZA). Counselors will take on 1 practice case each in TF-CBT. Local supervisors will meet with the counselors in groups on a weekly basis to monitor the intervention and will be in regular phone and email contact to assist with the initiation of cases. The US-based TF-CBT experts (Drs. Murray and Dorsey) will be in contact with the supervisors on a weekly basis (via skype) to assist with the supervision and provide ongoing support to the supervisors and the counselors. This follows the Apprenticeship Model of Training and Supervision (Murray et al., 2011).

As part of the study, 11 assessors will be trained on a comprehensive intake assessment process. The process uses an adapted initial intake form that is currently used by the partner organization to collect basic demographic, health, and other information about the client and a parent or guardian and adds a standard mental health and functioning assessment instrument based on the earlier qualitative and quantitative research conducted by the Johns Hopkins University (JHU) faculty. All children age 5-8 enrolled in the study will receive the demographics section, the PTSD-RI and the Shame measures as well as section one of the World AIDS Foundation measure that covers the topics of HIV Testing and Substance Abuse. Children ages 12 years and older will also receive the World Aids Foundation (WAF) questionnaire section 2 that asks questions related self-efficacy and sexual relationships and violence. Only children ages 12 and older who report yes to having experienced sexual intercourse of any form will be asked section 3 of the WAF which includes questions related to their relationship with their partner, sexual behaviors and HIV-risk behaviors commonly connected to trauma and mental health symptoms. Adults participating in the study will be given a demographics section, a section related to services received and the Child Behavior Checklist (CBCL).

The proposed study will be embedded within the ongoing SHARPZ program. We will study the effectiveness of TF-CBT for children who are affected by trauma with significant mental health symptomatology. The partner organizations will continue to provide services to anyone who seeks their services regardless of whether they meet eligibility for our proposed study, however those who meet our inclusion criteria will be invited to participate in the research component of the SHARPZ service program.

Qualitative exit interviews: Following completion of the therapy by the first set of 20 participants, assessors will ask these intervention participants what has changed since the intervention began and what change they attribute to the intervention. Interviews will be open ended, written by the assessors (not tape recorded) and identifying information will not be recorded. The research team will review these qualitative exit interviews to identify any unexpected positive or negative effects of the intervention. Questions on the more significant and/or frequent responses will be added to the original assessment instrument.

Post-intervention quantitative assessments will be done with the expanded assessment instrument (see qualitative exit interviews above). All post intervention quantitative interviews (including with the wait controls) will be conducted approximately 2-3 weeks after the client has completed the intervention or control period (approximately 12-14 weeks). Those randomized to the intervention will also receive a second post assessment 4 months after receiving the first post assessment. Control cases will only receive one post assessment after the wait list period so that they may then receive the intervention, unless found to be harmful or ineffective, as soon as their wait list period is over.

Following completion of the trial, the data will be analyzed, and if the intervention is found to be effective, it will become a permanent part of the services provided by the counselors at SHARPZ and the partner organizations.

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

Primary outcomes:
measure: Post Traumatic Stress Disorder- Reaction Index (RI)
timeFrame: Baseline and Follow-up within one month of treatment completion. For controls follow up was 4 months post baseline.
Secondary outcomes:
measure: Risk Reduction as Assessed by the World AIDS Foundation (WAF) Risk Reduction Scale
timeFrame: Baseline and follow-up within one month of treatment completion. For controls follow up was done 4 months post baseline.
measure: Child Behavior Checklist (CBCL) Score
timeFrame: Baseline and follow-up within one month of treatment completion. For controls follow up was done 4 months post baseline.
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Serenity Harm Reduction Programme Zambia
Study officials:
affiliation: Johns Hopkins University
name: Laura K Murray, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Paul Bolton, MBBS MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.