- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03954457
Social Ecology and the Prevention of Suicide and Aggression in African American Youth
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants were recruited from four urban, public schools, serving predominantly low-income, African American adolescents. Recruitment occurred over two years, with two cohorts of ninth-grade students recruited. Participants who returned student assent and active parent/guardian permission were screened for imminent suicide risk. Those participants who were identified as at imminent risk for suicide were referred to mental health professionals at the school-based health center for risk assessment and appropriate services. Participants not at imminent risk completed a baseline assessment of coping, aggression, and suicidality, and were randomly assigned to either the A-CWS intervention or standard care control conditions. Randomization occurred at the individual level.
Participants assigned to the A-CWS intervention condition received the 15-week A-CWS intervention. The intervention was facilitated by master's-level practitioners and implemented at the participating school during a non-instructional period of the school day. Intervention groups consisted of 8 to 10 participants, and intervention sessions were held for 45 minutes, once per week. Participants assigned to the standard care control condition were assigned to work with the school-based health center (SBHC) to receive standard behavioral services as delivered by SBHC mental health professionals.
To assess outcomes of adaptive coping, suicidality, and interpersonal aggression, participants were assessed at multiple timepoints. After completing a brief screening assessment, all participants, regardless of condition, were assessed a total of four times: (1) at baseline, prior to randomization, (2) immediately following the conclusion of the A-CWS intervention, (3) 6 months after the conclusion of the intervention, and (4) 12 months after the conclusion of the intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60614
- DePaul University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Enrolled ninth-grade student, their parent/guardian, or primary teacher at participating school
Exclusion Criteria:
- Imminent suicide risk
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: A-CWS Intervention
Participants received A-CWS Intervention.
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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.
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ACTIVE_COMPARATOR: Standard Care Control
Participants received standard care.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Suicide Ideation
Time Frame: Baseline, post-test, 6-month follow-up, 12-month follow-up
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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.
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Baseline, post-test, 6-month follow-up, 12-month follow-up
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Change in Aggression
Time Frame: Baseline, post-test, 6-month follow-up, 12-month follow-up
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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.
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Baseline, post-test, 6-month follow-up, 12-month follow-up
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Change in Coping
Time Frame: Baseline, post-test, 6-month follow-up, 12-month follow-up
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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.
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Baseline, post-test, 6-month follow-up, 12-month follow-up
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: LaVome Robinson, Ph.D., DePaul University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LR052913PSY
- R01HD072293 (NIH)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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