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

April 11, 2025 updated by: Martha E. Wadsworth, Penn State University

Confirmatory Efficacy of the Building a Strong Identity and Coping Skills Program for Low-income and Minoritized Young Adolescents

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Martha E Wadsworth, PhD
  • Phone Number: 814-865-2878
  • Email: mew27@psu.edu

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17110
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Health Medical Group - Psychiatry and Behavioral Health
        • Contact:
        • Contact:
          • Dara Babinski, Ph.D.
      • Spring Mills, Pennsylvania, United States, 16875
      • State College, Pennsylvania, United States, 16802
        • Recruiting
        • Dr. Edwin L. Herr Clinic
        • Contact:
        • Contact:
          • Martha Wadsworth, Ph.D.
      • State College, Pennsylvania, United States, 16802
        • Recruiting
        • Penn State Psychological Clinic
        • Contact:
        • Contact:
          • Martha Wadsworth, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Building a Strong Identity and Coping Skills
Psychoeducational program to teach children coping skills, healthy identity development, and collective social action
Other Names:
  • BaSICS
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: Pre-post (3 months) and Pre-follow up (6 and 12 months)
Changes in the number of anxiety problems that children report. Anxiety problems will be measured using the Screen for Child Anxiety Related Disorders (SCARED), Child Behavior Checklist (CBCL), and Youth Self Report (YSR).
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)
Changes in the number of depressive symptoms that children report. Depressive symptoms will be measured using the Patient Health Questionnaire (PHQ-9A), CBCL, and YSR.
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)
Changes in the number of suicide risk markers that children report. Suicide risk markers will be measured using the Child Trauma Screen (CTS) and Mini Kid.
Pre-post (3 months) and Pre-follow up (6 and 12 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Engagement Coping Skills Acquisition
Time Frame: Pre-post (3 months) and Pre-follow up (6 and 12 months)
Changes in the number of coping skills that children can report. Engagement Coping Skills Acquisition will be assessed with the Responses to Stress Questionnaire (RSQ), Children's Sadness Management Scale (CSMS) and Coping Skills Scale (CSS).
Pre-post (3 months) and Pre-follow up (6 and 12 months)
HPA Reactivity Profile
Time Frame: Pre-post (3 months) and Pre-follow up (6 and 12 months)
Changes in levels of salivary cortisol across a 90-minute Trier Social Stress Test (TSST) protocol
Pre-post (3 months) and Pre-follow up (6 and 12 months)
Collaborative Coping
Time Frame: Pre-post (3 months) and Pre-follow up (6 and 12 months)
Changes in the number of collaborative coping skills that children report. Collaborative Coping will be assessed with the Collaborative Coping Discussion, Youth Civic and Character Measure (YCCM), and Social Skills Improvement System (SSIS).
Pre-post (3 months) and Pre-follow up (6 and 12 months)
Sociocultural Identity Development
Time Frame: Pre-post (3 months) and Pre-follow up (6 and 12 months)
Changes in the sociocultural identity beliefs that children report. Sociocultural identity beliefs will be assessed with the Child and Adolescent Social Support (CASS), Early Identity Exploration Scale (EIES), and Multigroup Ethnic Identity Measure (MEIM).
Pre-post (3 months) and Pre-follow up (6 and 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penn State University

Investigators

  • Principal Investigator: Martha E Wadsworth, PhD, Penn State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Estimated)

May 31, 2029

Study Completion (Estimated)

May 31, 2029

Study Registration Dates

First Submitted

February 9, 2023

First Submitted That Met QC Criteria

March 28, 2023

First Posted (Actual)

March 29, 2023

Study Record Updates

Last Update Posted (Actual)

April 16, 2025

Last Update Submitted That Met QC Criteria

April 11, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAR-21-132

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data produced in the course of the project will be preserved and shared after de-identification. Item level spreadsheet data for all variables will be shared openly once cleaned. Data will be deposited into the National Institute of Mental Health Data Archive.

IPD Sharing Time Frame

Data will become available after de-identification and cleaning.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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