Randomized Control Trial on Trauma Focused CBT in Zambia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01624298
Recruitment Status : Unknown
Verified July 2013 by Laura Murray, Johns Hopkins Bloomberg School of Public Health.
Recruitment status was:  Recruiting
First Posted : June 20, 2012
Last Update Posted : July 23, 2013
Information provided by (Responsible Party):
Laura Murray, Johns Hopkins Bloomberg School of Public Health

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.

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

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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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : August 2012
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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 ( 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

Primary Outcome Measures :
  1. Post Traumatic Stress Disorder- Reaction Index [ Time Frame: 30 minutes ]
    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 :
  1. World AIDS Foundation (WAF) [ Time Frame: 45 minutes ]
    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.

  2. Child Behavior Checklist [ Time Frame: 1 hour ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01624298

Contact: Stephanie A Skavenski, MSW, MPH 260966674841

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Laura Murray, Assistant Scientist, Johns Hopkins Bloomberg School of Public Health Identifier: NCT01624298     History of Changes
Other Study ID Numbers: TFCBTRCTDCOF
First Posted: June 20, 2012    Key Record Dates
Last Update Posted: July 23, 2013
Last Verified: July 2013

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

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders