Cultural Adaptation of the TIM&SARA Prevention Program

Not Applicable

Terminated

• Conditions: Depressive Symptoms
• Interventions: Behavioral: TIM&SARA

• Registration Number: NCT03831139
• Lead Sponsor: University of Louisville

Brief Summary

Disparities between African-American and European-American youth regarding academic outcomes, mental health, and physical health exist. 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. Research demonstrates that European-American youth benefit more from programs preventing the development of depression than their African-American peers. Thus, the goals of this project are to (a) identify mechanisms that may result in differential program effectiveness across racial groups, and (b) adapt such a program (TIM\&SARA) so youth from diverse racial backgrounds benefit similarly. Freshmen in an urban high-school will participate in TIM\&SARA, fill out surveys and give biological data in saliva.

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 Timeline

• Study Start: 2015-08
• Study First Submitted: 2019-01-31
• Study First Submitted QC: 2019-02-04
• Study First Posted: 2019-02-05
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-29
• Last Update Posted: 2022-07-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 740

Inclusion Criteria

• 9th grade students in the participating high school

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prevention	TIM&SARA	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.

Primary Outcome Measures

Name	Time	Method
Center for Epidemiological Studies - Depression Scale (CES-D)	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).