Clinical trial NCT03954457: Social Ecology and the Prevention of Suicide and Aggression in African American Youth
Official title: Social Ecology and the Prevention of Suicide and Aggression in African American Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Aggression
Keywords: Suicide
Aggression
Prevention
Culturally-Adapted
African American Adolescents
Lead sponsor: DePaul University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-05-17
Enrollment: 939
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Imminent suicide risk

Primary outcomes:
measure: Change in Suicide Ideation
timeFrame: Baseline, post-test, 6-month follow-up, 12-month follow-up
measure: Change in Aggression
timeFrame: Baseline, post-test, 6-month follow-up, 12-month follow-up
measure: Change in Coping
timeFrame: Baseline, post-test, 6-month follow-up, 12-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: DePaul University
state: Illinois
Study officials:
affiliation: DePaul University
name: LaVome Robinson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: