Recruiting

Building a Strong Identity

Sponsor:

Penn State University

Code:

NCT05789446

Conditions

Chronic Stress

Anxiety

Depression

Eligibility Criteria

Sex: All

Age: 11+

Healthy Volunteers: Accepted

Interventions

Building a Strong Identity and Coping Skills

Study Details

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

Conditions

Chronic Stress

Anxiety

Depression

Study ID

NCT05789446

Start date

Feb 1, 2025

Status verified date

Sep, 2026

Completion date

May 31, 2030

Anticipated

Primary completion date

May 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11+

Healthy Volunteers: Accepted

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 Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BaSICS Intervention

Intervention = Building a String Identity and Coping Skills (BaSICS). Children randomized to participate in 16 twice weekly BaSICS intervention sessions. Children learn coping skills, identity development, and collective action as ways to buffer against chronic stress.

These children also complete pre- and post-intervention assessments, as well as 6-month and 12-month follow-up assessments.

no intervention: Control

These children complete assessments only--timed to coincide with the intervention groups' assessments: pre- and post-intervention assessments, as well as 6-month and 12-month follow-up assessments. No intervention.

Interventions

Building a Strong Identity and Coping Skills

Psychoeducational program to teach children coping skills, healthy identity development, and collective social action

Primary outcome measure

  • Anxiety [ Time Frame: Pre-post (3 months) and Pre-follow up (6 and 12 months) ]
  • Depression [ Time Frame: Pre-post (3 months) and Pre-follow up (6 and 12 months) ]
  • Suicide Risk Markers [ Time Frame: Pre-post (3 months) and Pre-follow up (6 and 12 months) ]

Central Contacts and Locations

Central contacts

Martha E Wadsworth, PhD

814-865-2878mew27@psu.edu

Dara Babinksi, PhD

dbabinski@pennstatehealth.psu.edu

Locations

Penn State Health Medical Group - Psychiatry and Behavioral Health

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Dara Babinski, PhD

dbabinski@pennstatehealth.psu.edu

Principal Investigator:

Dara Babinski, Ph.D.

Dr. Edwin L. Herr Clinic

Recruiting

State College, Pennsylvania, United States, 16802

Contacts

Kristen Nadermann, PhD

kmc452@psu.edu

Principal Investigator:

Martha Wadsworth, Ph.D.

Penn State Psychological Clinic

Recruiting

State College, Pennsylvania, United States, 16802

Contacts

Estee Hausman, PhD

exh471@psu.edu

Principal Investigator:

Martha Wadsworth, Ph.D.

More Information

Sponsor

Penn State University

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

Keywords

  • Poverty
  • Discrimination
  • Stress
  • Coping

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-04. This information was provided to ClinicalTrials.gov by Penn State University on 2026-09-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.