Randomized Control Trial on Trauma Focused CBT in Zambia

This study is currently recruiting participants. (see Contacts and Locations)

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

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:

MedlinePlus related topics: Post-Traumatic Stress Disorder Wounds and Injuries

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

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
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

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:


Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders

ClinicalTrials.gov processed this record on March 03, 2015

To Top