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

Last updated: April 11, 2025
Sponsor: Penn State University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stress

Depression

Treatment

Building a Strong Identity and Coping Skills

Clinical Study ID

NCT05789446
PAR-21-132
  • Ages > 11
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Intellectual disability

  • Autism spectrum disorder

  • High suicidal risk (score of 17 or more on the Mini International NeuropsychiatricInterview for Children and Adolescents (MINI-Kid))

  • Severe depression (score of 19 or more on Patient health questionnaire (PHQ).

Study Design

Total Participants: 360
Treatment Group(s): 1
Primary Treatment: Building a Strong Identity and Coping Skills
Phase:
Study Start date:
February 01, 2025
Estimated Completion Date:
May 31, 2029

Connect with a study center

  • Pennsylvania Psychiatric Institute

    Harrisburg, Pennsylvania 17110
    United States

    Site Not Available

  • Penn State Health Medical Group - Psychiatry and Behavioral Health

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • Penns Valley Area School District

    Spring Mills, Pennsylvania 16875
    United States

    Site Not Available

  • Dr. Edwin L. Herr Clinic

    State College, Pennsylvania 16802
    United States

    Active - Recruiting

  • Penn State Psychological Clinic

    State College, Pennsylvania 16802
    United States

    Active - Recruiting

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