NCT03954457

Brief Summary

The purpose of this study is to examine the efficacy of a culturally-grounded, school-based suicide and aggression preventive intervention for African American adolescents (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 for coping with stress. Emphasis is given to the identification of stress unique to the day-to-day experiences of the youths and options for reducing stress that are culturally consistent. A total of four public high schools in a large Midwestern metropolitan area participated in this study that used a randomized-controlled design, with randomization occurring at the individual level. Participants were randomized either to the A-CWS intervention condition, or to a standard care control condition. This study had three hypotheses: (1) The intervention would raise adaptive coping, relative to the standard care control condition; (2) coping skills would explain the effects of the A-CWS intervention on problematic outcomes (i.e., suicidality, aggression); and (3) socio-ecological factors (i.e., neighborhood and family characteristics) would influence the effect of the A-CWS intervention on coping skills, and the effect of coping skills on problematic outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
939

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2013

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

7.5 years

First QC Date

May 15, 2019

Last Update Submit

August 16, 2021

Conditions

Keywords

SuicideAggressionPreventionCulturally-AdaptedAfrican American Adolescents

Outcome Measures

Primary Outcomes (3)

  • Change in Suicide Ideation

    Suicide ideation was measured with the Center for Epidemiological Studies - Depression (CES-D) Appended Suicide Measure, a 4-item self-report inventory that assesses suicide ideation during the last week.

    Baseline, post-test, 6-month follow-up, 12-month follow-up

  • Change in Aggression

    Aggression was measured with a reduced 12-item version of the Aggression-Problem Behavior Frequency Scale, a self-report inventory that assesses the frequency of aggression in the last 30 days. This instrument has two subscales: physical aggression and non-physical aggression. Aggression was also measured using the Buss-Perry Aggression Questionnaire Short Form, a 12-item self-report inventory of aggression with four subscales: physical aggression, verbal aggression, anger, and hostility. In addition, aggression was measured with student behavioral data from participating schools, including number of detentions, suspensions, and reasons for detentions/suspensions. This data was used to identify the number of aggressive episodes per student and provided a secondary, archival measure of aggression.

    Baseline, post-test, 6-month follow-up, 12-month follow-up

  • Change in Coping

    Coping was measured with a reduced 36-item version of the Adolescent Coping Orientation for Problem Experiences Measure, a self-report inventory that assesses frequency of use for coping methods used in response to stress. Seven subscales were included to assess preferred coping styles targeted by the intervention: ventilating feelings, seeking diversions, developing self-reliance, developing social support, investing in close friends, engaging in demanding activity, and relaxing.

    Baseline, post-test, 6-month follow-up, 12-month follow-up

Study Arms (2)

A-CWS Intervention

EXPERIMENTAL

Participants received A-CWS Intervention.

Behavioral: A-CWS

Standard Care Control

ACTIVE COMPARATOR

Participants received standard care.

Behavioral: Standard Care Control

Interventions

A-CWSBEHAVIORAL

The A-CWS intervention is a 15-session culturally-grounded, cognitive-behavioral group intervention designed to develop and enhance African American youths' skills for coping with stress. The intervention structure allows implementation within traditional school and other community settings. The A-CWS uses standard cognitive-behavioral strategies (e.g., relaxation training, cognitive restructuring) to help African American youth identify and cope with individual and contextual stressors, using culturally consistent coping strategies. The intervention emphasizes the identification and management of stressors associated with suicide risk (e.g., racism-related stress, community violence exposure) and the unique experiences of low-resourced, urban African American adolescents (e.g., community violence exposure). The structured, manualized A-CWS curriculum is designed to be sustainable and user-friendly, to ensure that the A-CWS is delivered effectively and with a high degree of fidelity.

A-CWS Intervention

The standard care control condition consisted of standard case management services delivered by the SBHC. Participants randomly assigned to the standard care control condition were referred to the SBHC social worker for case management. Standard care ranged from brief intervention by the SBHC social worker, to more intensive intervention by the SBHC social worker, to outside referral to local community service providers. SBHC social workers determined type and duration of services based on individual participant needs.

Standard Care Control

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Enrolled ninth-grade student, their parent/guardian, or primary teacher at participating school

You may not qualify if:

  • Imminent suicide risk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DePaul University

Chicago, Illinois, 60614, United States

Location

Related Publications (1)

  • Robinson WL, Whipple CR, Keenan K, Flack CE, Lemke S, Jason LA. Reducing suicidal ideation in African American adolescents: A randomized controlled clinical trial. J Consult Clin Psychol. 2024 Feb;92(2):61-74. doi: 10.1037/ccp0000849. Epub 2023 Sep 28.

MeSH Terms

Conditions

SuicideAggression

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorAberrant Motor Behavior in DementiaSocial Behavior

Study Officials

  • LaVome Robinson, Ph.D.

    DePaul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

May 15, 2019

First Posted

May 17, 2019

Study Start

February 5, 2013

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

August 17, 2021

Record last verified: 2021-08

Locations