RecruitingRecruiting
Confirmatory Efficacy of the Building a Strong Identity and Coping Skills Program
NCT05789446 · Penn State University
In plain English
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Official title
Confirmatory Efficacy of the Building a Strong Identity and Coping Skills Program for Low-income and Minoritized Young Adolescents
About this study
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).
Study design
Enrollment target: 360 participants
Allocation: randomized
Masking: single
Age groups: child, adult, older_adult
Timeline
Starts: 2025-02-01
Estimated completion: 2029-05-31
Last updated: 2025-04-16
Interventions
Behavioral: Building a Strong Identity and Coping Skills
Primary outcomes
- • Anxiety (Pre-post (3 months) and Pre-follow up (6 and 12 months))
- • Depression (Pre-post (3 months) and Pre-follow up (6 and 12 months))
- • Suicide Risk Markers (Pre-post (3 months) and Pre-follow up (6 and 12 months))
Sponsor
Penn State University · other
Contacts & investigators
ContactMartha E Wadsworth, PhD · contact · mew27@psu.edu · 814-865-2878
ContactDara Babinksi, PhD · contact · dbabinski@pennstatehealth.psu.edu
InvestigatorMartha E Wadsworth, PhD · principal_investigator, Penn State University
All locations (5)
Pennsylvania Psychiatric InstituteNot Yet Recruiting
Harrisburg, Pennsylvania, United States
Penn State Health Medical Group - Psychiatry and Behavioral HealthRecruiting
Hershey, Pennsylvania, United States
Penns Valley Area School DistrictNot Yet Recruiting
Spring Mills, Pennsylvania, United States
Dr. Edwin L. Herr ClinicRecruiting
State College, Pennsylvania, United States
Penn State Psychological ClinicRecruiting
State College, Pennsylvania, United States