Randomized Control Trial on Trauma Focused CBT in Zambia
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Post Traumatic Stress Disorder Depression Risk Behaviors||Behavioral: Trauma Focused Cognitive Behavioral Therapy||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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).
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01624298
|Contact: Stephanie A Skavenski, MSW, MPHfirstname.lastname@example.org|
|Serenity Harm Reduction Programme Zambia||Recruiting|
|Lusaka, Zambia, 10101|
|Principal Investigator:||Laura K Murray, PhD||Johns Hopkins University|
|Principal Investigator:||Paul Bolton, MBBS MPH||Johns Hopkins Bloomberg School of Public Health|