Clinical trial NCT05789446: Confirmatory Efficacy of the Building a Strong Identity and Coping Skills Program
Official title: Confirmatory Efficacy of the Building a Strong Identity and Coping Skills Program for Low-income and Minoritized Young Adolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Stress
Anxiety
Depression
Keywords: Poverty
Discrimination
Stress
Coping
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2023-03-29
Enrollment: 360
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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).

Primary outcomes:
measure: Anxiety
timeFrame: Pre-post (3 months) and Pre-follow up (6 and 12 months)
measure: Depression
timeFrame: Pre-post (3 months) and Pre-follow up (6 and 12 months)
measure: Suicide Risk Markers
timeFrame: Pre-post (3 months) and Pre-follow up (6 and 12 months)
Secondary outcomes:
measure: Engagement Coping Skills Acquisition
timeFrame: Pre-post (3 months) and Pre-follow up (6 and 12 months)
measure: HPA Reactivity Profile
timeFrame: Pre-post (3 months) and Pre-follow up (6 and 12 months)
measure: Collaborative Coping
timeFrame: Pre-post (3 months) and Pre-follow up (6 and 12 months)
measure: Sociocultural Identity Development
timeFrame: Pre-post (3 months) and Pre-follow up (6 and 12 months)
Other outcomes:
Locations:
city: Harrisburg
country: United States
facility: Pennsylvania Psychiatric Institute
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Health Medical Group - Psychiatry and Behavioral Health
state: Pennsylvania
city: Spring Mills
country: United States
facility: Penns Valley Area School District
state: Pennsylvania
city: State College
country: United States
facility: Dr. Edwin L. Herr Clinic
state: Pennsylvania
city: State College
country: United States
facility: Penn State Psychological Clinic
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Martha E Wadsworth, PhD
role: PRINCIPAL_INVESTIGATOR
References: