Cultural Adaptation of the TIM&SARA Prevention Program

Depressive Symptoms Clinical Trial

Official title:

What Makes Prevention Work? Cultural Adaptation of an Effective Program for African-American Adolescents

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03831139
• Other study ID #: 15.0318
• Status: Terminated
• Phase: N/A
• Start date: August 2015
• Est. completion date: March 2019

Study information

• Verified date: June 2022
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 740
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 9th grade students in the participating high school Exclusion Criteria: -

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

Intervention

Behavioral:
• TIM&SARA

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (a = .92, Winkeljohn Black, & Pössel, 2015).	5 minutes