Actively Recruiting

Phase Not Applicable
Age: 11Years +
All Genders
Healthy Volunteers
NCT05789446

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

Led by Penn State University · Updated on 2025-04-16

360

Participants Needed

5

Research Sites

225 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 11Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children ages 11-14 at intake
  • Family income at or below 200% federal poverty level
  • Child speaks English
  • Parent speaks English or Spanish
Not Eligible

You will not qualify if you...

  • Intellectual disability
  • Autism spectrum disorder
  • High suicidal risk (score of 17 or more on the Mini International Neuropsychiatric Interview for Children and Adolescents)
  • Severe depression (score of 19 or more on Patient Health Questionnaire)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 5 locations

1

Pennsylvania Psychiatric Institute

Harrisburg, Pennsylvania, United States, 17110

Not Yet Recruiting

2

Penn State Health Medical Group - Psychiatry and Behavioral Health

Hershey, Pennsylvania, United States, 17033

Actively Recruiting

3

Penns Valley Area School District

Spring Mills, Pennsylvania, United States, 16875

Not Yet Recruiting

4

Dr. Edwin L. Herr Clinic

State College, Pennsylvania, United States, 16802

Actively Recruiting

5

Penn State Psychological Clinic

State College, Pennsylvania, United States, 16802

Actively Recruiting

Loading map...

Research Team

M

Martha E Wadsworth, PhD

CONTACT

D

Dara Babinksi, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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