Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-24 @ 6:32 PM
NCT ID:
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.
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:
NCT03954457
Study Brief:
Protocol Section:
NCT03954457