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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04253002
Other study ID # LR060519PSY
Secondary ID 1R01MH1183182
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date June 30, 2026

Study information

Verified date June 2024
Source DePaul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The overarching aim of the Success Over Stress Prevention Project is to reduce African American youth suicide. This study examines the impact of a 15-session, group-delivered, culturally-grounded, cognitive-behavioral intervention (i.e., PI Robinson's Adapted-Coping with Stress Course [A-CWS]), on the outcomes of interest, when it is delivered by social workers who are indigenous to the school system. The main objectives of this project are to (a) determine whether the intervention is effective when facilitated by social workers who are indigenous to the school system and (b) enhance resilience, increase adaptive coping strategies, and reduce both intrapersonal and interpersonal violence among youth receiving the prevention intervention. It is expected that increases in adaptive coping will lead to an increased ability for youth to manage stressors, thereby decreasing the incidence of suicide and violence among the youth. In addition, it is expected that evidence of the intervention's effectiveness, when facilitated by social workers who are indigenous to the school system, will lead to greater dissemination and sustainability of the intervention, thus, providing access to effective intervention resources to greater numbers of African American youth.


Description:

This study will establish the effectiveness of Robinson's Adapted-Coping with Stress Course (A-CWS) and test hypotheses pertaining to the mechanism of change by which the A-CWS reduces suicide risk. Additionally, this study is expected to augment current theoretical models of adolescent suicidality. This effectiveness trial will inform procedures for scaling up efficacious, high quality, and culturally-grounded suicide prevention programs for low-resourced, urban African American youth; as such, this study is practice relevant and expected to inform best practices for the prevention of suicide among African American adolescents. The specific aims are: 1. To examine the effectiveness of the A-CWS intervention, as delivered by social workers who are indigenous to the school system, to reduce active suicidal ideation, within a sample of low-resourced, urban African American adolescents. 2. To understand the mechanism by which the A-CWS intervention reduces suicide risk for low-resourced, urban African American adolescents. 3. To establish the fidelity of an evidence-based, culturally-grounded coping with stress intervention (i.e., the A-CWS), developed for low-resourced, urban African American adolescents, delivered by social workers indigenous to the school system. 4. To understand the extent that thwarted belongingness, perceived burdensomeness, and socio-ecological factors influence the development of active suicidal ideation.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 512
Est. completion date June 30, 2026
Est. primary completion date June 30, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - Students: Enrolled 9th grade student at time of initial enrollment at participating high school - Parents/guardians: Child enrolled in study - Teachers: Student enrolled in study Exclusion Criteria: - Not a 9th grade student at time of initial enrollment - No parent/legal guardian permission - For parents and teachers: no students enrolled in study

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Robinson's Culturally Adapted Coping with Stress Course (A-CWS)
Participants randomized to the experimental condition will take part in the Adapted Coping with Stress Course (A-CWS). The A-CWS is a 15-session, cognitive-behavioral group intervention designed to develop and enhance African American youths' skills to adaptively cope with stress, using standard cognitive-behavioral strategies such as relaxation training and cognitive restructuring. Emphasis is given to the identification of individual and contextual factors associated with suicide risk and the unique day-to-day experiences of the youth, providing options for adaptive coping (e.g., positive thinking) that are culturally consistent. The A-CWS is structured and manualized to allow its transportability to service providers working in similar environments with similar youth.
Standard Care Control Condition
Students meeting criteria for study inclusion and randomized into the standard care condition will be referred to the school-based health center (SBHC) mental health provider for case management. Standard care may range from (1) brief intervention by the SBHC mental health provider to (2) outside referral to local community service providers; these determinations will be made by the SBHC mental health team.

Locations

Country Name City State
United States DePaul University Chicago Illinois
United States Dunbar Vocational Career Academy Chicago Illinois
United States Orr Academy High School Chicago Illinois
United States Richard T. Crane High School Chicago Illinois
United States Wendell Phillips Academy High School Chicago Illinois
United States Proviso East High School Maywood Illinois

Sponsors (2)

Lead Sponsor Collaborator
DePaul University National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Suicide Ideation Suicide ideation will be measured using the Suicidal Ideation Questionnaire (SIQ-JR), a 15-item measure of adolescents' distress and suicidal intent. Scale scores range from 0 to 90, with higher scores meaning a worse outcome (i.e., greater suicide ideation). Assessments will be administered through study completion, an average of every six months.
Secondary Change in Adaptive Coping Adaptive Coping will be measured using The Adolescent Coping Orientation for Problem Behaviors (A-COPE), which is a 54 item self-report questionnaire that measures coping strategies among adolescents Assessments will be administered through study completion, an average of every six months.
Secondary Change in Hope Hope will be measured using the The Children's Hope Scale (CHS), a six-item self-report measure of children's perceived interpersonal competencies, including the belief that their goals can be met. Assessments will be administered through study completion, an average of every six months.
Secondary Change in Hopelessness Hopelessness will be measured using the Hopelessness Scale for Children (HSC). The HSC consists of 17 true-false items. The domains measured include: feelings about the future, loss of motivation, and future expectations Assessments will be administered through study completion, an average of every six months.
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