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Randomized Control Trial on Trauma Focused CBT in Zambia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2013 by Johns Hopkins Bloomberg School of Public Health.
Recruitment status was  Recruiting
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
History of Changes
  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:

U.S. FDA Resources

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

  Show Detailed Description

  Eligibility
Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 28, 2016