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

ClinicalTrials.gov IDNCT05789446

PhaseNA

Enrollment360

SponsorPenn State University

Age11 Years

SexALL

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Conditions studied

Chronic Stress, Anxiety, Depression

About this study

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

Interventions

Behavioral: Building a Strong Identity and Coping Skills — Psychoeducational program to teach children coping skills, healthy identity development, and collective social action

Primary outcomes

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))

Eligibility information

Inclusion Criteria: * Children ages 11-14 at intake * Family income at or below 200% federal poverty level * Child speaks English * Parent speaks English or Spanish Exclusion Criteria: * 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).

Study locations

Pennsylvania Psychiatric Institute, Harrisburg, Pennsylvania 17110 United States
Penn State Health Medical Group - Psychiatry and Behavioral Health, Hershey, Pennsylvania 17033 United States
Penns Valley Area School District, Spring Mills, Pennsylvania 16875 United States
Dr. Edwin L. Herr Clinic, State College, Pennsylvania 16802 United States
Penn State Psychological Clinic, State College, Pennsylvania 16802 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.