Depression Clinical Trial
Official title:
A Randomized Control Trial to Determine the Effectiveness of Trauma Focused Cognitive Behavioral (TF-CBT) Among Children in Lusaka, Zambia
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.
Status | Unknown status |
Enrollment | 250 |
Est. completion date | December 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years to 18 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Zambia | Serenity Harm Reduction Programme Zambia | Lusaka |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins Bloomberg School of Public Health |
Zambia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post Traumatic Stress Disorder- Reaction Index | 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). | 30 minutes | |
Secondary | World AIDS Foundation (WAF) | 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. | 45 minutes | |
Secondary | Child Behavior Checklist | 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. | 1 hour |
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