Randomized Control Trial on Trauma Focused CBT in Zambia

This study is currently recruiting participants.
Verified July 2013 by Johns Hopkins Bloomberg School of Public Health
Sponsor:
Information provided by (Responsible Party):
Laura Murray, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01624298
First received: June 18, 2012
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Post Traumatic Stress Disorder
Depression
Risk Behaviors
Behavioral: Trauma Focused Cognitive Behavioral Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Control Trial to Determine the Effectiveness of Trauma Focused Cognitive Behavioral (TF-CBT) Among Children in Lusaka, Zambia

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Post Traumatic Stress Disorder- Reaction Index [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    The PTSD-RI assesses specific traumatic events a child has experienced or witnessed, and the associated mental health symptoms to such stressors. 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 JHU faculty preliminary studies (Murray et al., 2011).


Secondary Outcome Measures:
  • World AIDS Foundation (WAF) [ Time Frame: 45 minutes ] [ Designated as safety issue: Yes ]
    Potentially risky sexual activity and substance use and abuse will be measured using the World AIDS Foundation (WAF) survey, developed and used with adolescents in South Africa. This measure was adapted for use in Zambia.

  • Child Behavior Checklist [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    A standardized measure developed and validated initially in the West but now used in many countries and cultures. This measure asks parents/guardians to report on a range of behavioral and school problems, somatic complaints, depression and anxiety symptoms that a parent/guardian may see in their child. The Child Behavior Check List (CBCL) has been used internationally and was translated and validated in Zambia in our preliminary studies. It will be used as a caregiver report on the general problems of the child/adolescent.


Estimated Enrollment: 250
Study Start Date: August 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Wait List Control Group
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.
Experimental: Intervention Group
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
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.
Other Name: TF-CBT

  Hide Detailed Description

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 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

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Youth found to exhibit significant trauma symptomatology as evidenced by a score of 39 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624298

Contacts
Contact: Stephanie A Skavenski, MSW, MPH 260966674841 sskavenski@yahoo.com

Locations
Zambia
Serenity Harm Reduction Programme Zambia Recruiting
Lusaka, Zambia, 10101
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
Principal Investigator: Laura K Murray, PhD Johns Hopkins University
Principal Investigator: Paul Bolton, MBBS MPH Johns Hopkins School of Public Health
  More Information

No publications provided

Responsible Party: Laura Murray, Assistant Scientist, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01624298     History of Changes
Other Study ID Numbers: TFCBTRCTDCOF
Study First Received: June 18, 2012
Last Updated: July 22, 2013
Health Authority: Zambia: Ministry of Health

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Randomized controlled trial
Traumatized youth
HIV risk

Additional relevant MeSH terms:
Depression
Depressive Disorder
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Behavioral Symptoms
Mood Disorders
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on April 22, 2014