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Life sciences · Interventional Study
ClinicalTrials.gov · September 17, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT05789446). This is a study registration, not published results. Lead sponsor: Penn State University. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 360 participants (ESTIMATED). Conditions: Chronic Stress, Anxiety, Depression. Interventions: BEHAVIORAL: Building a Strong Identity and Coping Skills. Primary outcome measures: Anxiety , Pre-post (3 months) and Pre-follow up (6 and 12 months); Depression , Pre-post (3 months) and Pre-follow up (6 and 12 months); Suicide Risk Markers , Pre-post (3 months) and Pre-follow up (6 and 12 months). Brief summary: The goal of this clinical trial is to the efficacy of the Building a Strong Identity and Coping Skills intervention within a sample of low-income and minoritized youth aged 11-14 who are seeking mental health treatment and have been placed on a waitlist to receive services. The aims of this study are to: (1) confirm the efficacy of BaSICS by replicating previous findings, (2) Examine the changes of coping mechanisms and symptom change over the course of the BaSICS intervention, and (3) test models of physiologic stress reactivity and regulation to capture biological "risk" and recalibration. Cohorts of 20 participants will randomly be enrolled in either the intervention (10) or control (10) groups. Participants enrolled in the intervention group will complete the BaSICS program and participants enrolled in the no intervention group will not be enrolled in the intervention program. The BaSICS program is designed to help treat anxiety, depression, and post-traumatic stress symptoms and disorders and have direct effects on physiologic stress response systems (hypothalamic-pituitary-adrenal (HPA) axis). Researchers will compare the intervention and no intervention groups to see if there is a difference in the reduction of markers for anxiety, depression, and suicide scores, changes in coping mechanism, and HPA reactivity profiles