Cultural Adaptation of the TIM&SARA Prevention Program

Sponsor
University of Louisville (Other)
Overall Status
Terminated
CT.gov ID
NCT03831139
Collaborator
(none)
740
2
43

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: TIM&SARA
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
740 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
What Makes Prevention Work? Cultural Adaptation of an Effective Program for African-American Adolescents
Actual Study Start Date :
Aug 1, 2015
Actual Primary Completion Date :
Mar 1, 2019
Actual Study Completion Date :
Mar 1, 2019

Arms and Interventions

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.

Behavioral: TIM&SARA

No Intervention: Control

The youth participate in school as usual.

Outcome Measures

Primary Outcome Measures

  1. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 9th grade students in the participating high school
Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Louisville

Investigators

  • Principal Investigator: Patrick Possel, Dr.rer.soc., University of Louisville

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Patrick Possel, Professor, University of Louisville
ClinicalTrials.gov Identifier:
NCT03831139
Other Study ID Numbers:
  • 15.0318
First Posted:
Feb 5, 2019
Last Update Posted:
Jul 5, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 5, 2022