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

The Pennsylvania State University (PENNSTATE)

Status: Enrolling

Conditions: Depression; Anxiety; Chronic Stress

Treatments: Behavioral: Building a Strong Identity and Coping Skills

Study type: Interventional

Funder types: Other

Identifiers

NCT05789446

PAR-21-132

Details and patient eligibility

About

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

Enrollment: 360 estimated patients

Sex: All

Ages: 11+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 2 patient groups

BaSICS Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Building a Strong Identity and Coping Skills

Control

No Intervention group

Description:

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.