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

NCT05789446 | Recruiting DMC

• 1 other identifier: PAR-21-132
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 5

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

Keywords

Poverty; Discrimination; Stress; Coping

Outcome Measures

Primary Outcomes (3)

• Anxiety

  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

  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

  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 Outcomes (4)

• Engagement Coping Skills Acquisition

  Pre-post (3 months) and Pre-follow up (6 and 12 months)

• HPA Reactivity Profile

  Pre-post (3 months) and Pre-follow up (6 and 12 months)

• Collaborative Coping

  Pre-post (3 months) and Pre-follow up (6 and 12 months)

• Sociocultural Identity Development

  Pre-post (3 months) and Pre-follow up (6 and 12 months)

Study Arms (2)

BaSICS Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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 BEHAVIORAL

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

Also known as: BaSICS

BaSICS Intervention

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Children ages 11-14 at intake
• Family income at or below 200% federal poverty level
• Child speaks English
• Parent speaks English or Spanish

You may not qualify if:

• 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).

Sponsors & Collaborators

• Penn State University: lead

Study Sites (5)

Pennsylvania Psychiatric Institute

Harrisburg, Pennsylvania, 17110, United States

NOT YET RECRUITING

Penn State Health Medical Group - Psychiatry and Behavioral Health

Hershey, Pennsylvania, 17033, United States

RECRUITING

Penns Valley Area School District

Spring Mills, Pennsylvania, 16875, United States

NOT YET RECRUITING

Dr. Edwin L. Herr Clinic

State College, Pennsylvania, 16802, United States

RECRUITING

Penn State Psychological Clinic

State College, Pennsylvania, 16802, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Coping Skills

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Martha E Wadsworth, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martha E Wadsworth, PhD

CONTACT

814-865-2878; mew27@psu.edu

Dara Babinksi, PhD

CONTACT

dbabinski@pennstatehealth.psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 29, 2023
• Study Start: February 1, 2025
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2029
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will become available after de-identification and cleaning.

Locations

US (5)