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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05789446
• Other study ID #: PAR-21-132
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2025
• Est. completion date: August 30, 2029

Study information

• Verified date: June 2024
• Source: Penn State University
• Contact: Martha E Wadsworth, PhD
• Phone: 814-865-2878
• Email: mew27[@]psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: August 30, 2029
• Est. primary completion date: January 1, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety
• Chronic Stress
• Depression

Intervention

Behavioral:
• Building a Strong Identity and Coping Skills
Psychoeducational program to teach children coping skills, healthy identity development, and collective social action

Locations

Country	Name	City	State
United States	Pennsylvania Psychiatric Institute	Harrisburg	Pennsylvania
United States	Penn State Health Medical Group - Psychiatry and Behavioral Health	Hershey	Pennsylvania
United States	Penns Valley Area School District	Spring Mills	Pennsylvania
United States	Dr. Edwin L. Herr Clinic	State College	Pennsylvania
United States	Penn State Psychological Clinic	State College	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Engagement Coping Skills Acquisition	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)
Secondary	HPA Reactivity Profile	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)
Secondary	Collaborative Coping	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)
Secondary	Sociocultural Identity Development	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)