Cultural Adaptation of the TIM&SARA Prevention Program

NCT03831139 | Terminated

• 1 other identifier: 15.0318
• Study Type: interventional
• Target: 740
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

• Center for Epidemiological Studies - Depression Scale (CES-D)

  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).

  5 minutes

Study Arms (2)

Prevention

EXPERIMENTAL

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

Control

NO INTERVENTION

The youth participate in school as usual.

Interventions

TIM&SARA BEHAVIORAL

Prevention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• th grade students in the participating high school

Sponsors & Collaborators

• University of Louisville: lead

Related Publications (1)

• Seely HD, Possel P. Equity and inclusion in prevention: Depression prevention in Black and White American youth. J Consult Clin Psychol. 2025 Apr;93(4):307-316. doi: 10.1037/ccp0000918.

  PMID: 40126558 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Patrick Possel, Dr.rer.soc.

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 5, 2019
• Study Start: August 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: July 5, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share