- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03831139
Cultural Adaptation of the TIM&SARA Prevention Program
What Makes Prevention Work? Cultural Adaptation of an Effective Program for African-American Adolescents
Study Overview
Detailed Description
Already in adolescence, substantial disparities between African-Americans and European-Americans regarding academic outcomes, mental health, and physical health like cardiovascular health exist. While these domains are often treated as unrelated, they influence each other in a way that the disparity in one variable increases the likelihood for disparity in the others. Depression, a very common mental health problem, plays a central role by impacting academic outcomes and cardiovascular health. Thus, a program that successfully reduces the likelihood for youths to develop depression should also reduce problems with academic outcomes and physical health and therefore reduce disparity in all three domains. Unfortunately, research demonstrates that European-American youth benefit more from programs preventing the development of depression than their African-American peers. Thus, the main goals of this research project are to (a) identify mechanisms that may result in differential prevention program effectiveness across youth race groups, and (b) adapt such a program (TIM&SARA) so youth from diverse racial backgrounds benefit similarly.
In this project, the depression prevention program TIM&SARA will be implemented as part of the normal school curriculum for freshmen in an urban high-school. The differential effects of the program on African-American and European-American youths will be examined using surveys and biological data in saliva.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 9th grade students in the participating high school
Exclusion Criteria:
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Prevention
TIM&SARA has a duration of 16 fifty-minute sessions and is organized in five modules.
The first module (2 sessions) outlines the rationale for the program and establishes connections between group leaders and adolescents.
The next module (2 sessions) focuses on helping adolescents to consider already existing goals, set new ones, and learn how to achieve goals to build up the motivation of the youth to learn and apply the material of the following modules.
The third module (6 sessions) focuses on understanding the relations among cognitions, emotions, and behaviors, and teaching the participating youths how to identify and challenge negative cognitions.
The forth module (5 sessions) trains the youth in assertive and social competent social behavior.
Finally, the last session is a review session and includes a celebration.
All parts of the program use illustrative, culturally relevant situations introduced by the participating adolescents.
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No Intervention: Control
The youth participate in school as usual.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Center for Epidemiological Studies - Depression Scale (CES-D)
Time Frame: 5 minutes
|
The CES-D is a 20-item self-report instrument which has been repeatedly used in adolescent samples (e.g., Roberts et al., 1990) will be used.
Items are rated on a 4-point Likert scale (0 = rarely or none of the time; 3 = most of the time; e.g., "I was bothered by things that usually don't bother me.").
The scale ranges from 0-60; total scores of 16 or higher indicate clinically significant depressive symptoms.
The internal consistency of the CES-D in previous studies with adolescents is good (α = .92,
Winkeljohn Black, & Pössel, 2015).
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5 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patrick Possel, Dr.rer.soc., University of Louisville
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15.0318
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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