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NCT Number: NCT05789446

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

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

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Key information

Conditions

Chronic Stress Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

11 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennsylvania Psychiatric Institute, Harrisburg, Pennsylvania, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Building a Strong Identity and Coping Skills

Behavioral

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

Other names: BaSICS

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

Secondary outcomes

  1. 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).

  2. 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

  3. 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).

  4. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Dara Babinksi, PhD

CONTACT

[email protected]

Martha E Wadsworth, PhD

CONTACT

[email protected]

814-865-2878

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Mar 29, 2023
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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