Confirmatory Efficacy of the Building a Strong Identity and Coping Skills Program
NCT ID: NCT05789446
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
360 participants
INTERVENTIONAL
2025-02-01
2029-05-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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BaSICS Intervention
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.
Building a Strong Identity and Coping Skills
Psychoeducational program to teach children coping skills, healthy identity development, and collective social action
Control
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.
No interventions assigned to this group
Interventions
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Building a Strong Identity and Coping Skills
Psychoeducational program to teach children coping skills, healthy identity development, and collective social action
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Family income at or below 200% federal poverty level
* Child speaks English
* Parent speaks English or Spanish
Exclusion Criteria
* 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).
11 Years
ALL
Yes
Sponsors
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Penn State University
OTHER
Responsible Party
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Martha E. Wadsworth
Professor of Psychology
Principal Investigators
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Martha E Wadsworth, PhD
Role: PRINCIPAL_INVESTIGATOR
Penn State University
Locations
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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, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PAR-21-132
Identifier Type: -
Identifier Source: org_study_id
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