Confirmatory Efficacy of the Building a Strong Identity and Coping Skills Program

Recruiting now · Not applicable

Conditions studied: Chronic Stress, Anxiety, Depression

In brief

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

Key facts

Study ID

NCT05789446

Run by

Penn State University

People needed

360

Starts

2025-02-01

Expected to finish

2029-05-31

Last updated by the study team

2025-04-16

Who can join

Age: 11 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Children ages 11-14 at intake
• Family income at or below 200% federal poverty level
• Child speaks English
• Parent speaks English or Spanish

You may not qualify if…

• Intellectual disability
• Autism spectrum disorder
• High suicidal risk (score of 17 or more on the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-Kid))
• Severe depression (score of 19 or more on Patient health questionnaire (PHQ).

Where it is running

• Penn State Health Medical Group - Psychiatry and Behavioral Health — Hershey, Pennsylvania, United States (enrolling)
• Dr. Edwin L. Herr Clinic — State College, Pennsylvania, United States (enrolling)
• Penn State Psychological Clinic — State College, Pennsylvania, United States (enrolling)
• Pennsylvania Psychiatric Institute — Harrisburg, Pennsylvania, United States
• Penns Valley Area School District — Spring Mills, Pennsylvania, United States

Full record on ClinicalTrials.gov

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