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

Not Applicable

Not yet recruiting

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

Recruitment & Eligibility

Inclusion Criteria

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).

Arm && Interventions

Group	Intervention	Description
BaSICS Intervention	Building a Strong Identity and Coping Skills	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.

Primary Outcome Measures

Name	Time	Method
Suicide Risk Markers	Pre-post (3 months) and Pre-follow up (6 and 12 months)	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.
Anxiety	Pre-post (3 months) and Pre-follow up (6 and 12 months)	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).
Depression	Pre-post (3 months) and Pre-follow up (6 and 12 months)	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.

Secondary Outcome Measures

Name	Time	Method
Engagement Coping Skills Acquisition	Pre-post (3 months) and Pre-follow up (6 and 12 months)	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).
Collaborative Coping	Pre-post (3 months) and Pre-follow up (6 and 12 months)	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).
HPA Reactivity Profile	Pre-post (3 months) and Pre-follow up (6 and 12 months)	Changes in levels of salivary cortisol across a 90-minute Trier Social Stress Test (TSST) protocol
Sociocultural Identity Development	Pre-post (3 months) and Pre-follow up (6 and 12 months)	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).

Locations (5): Penns Valley Area School District
🇺🇸
Spring Mills, Pennsylvania, United States
Penn State Health Medical Group - Psychiatry and Behavioral Health
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Hershey, Pennsylvania, United States
Pennsylvania Psychiatric Institute
🇺🇸
Harrisburg, Pennsylvania, United States
Dr. Edwin L. Herr Clinic
🇺🇸
State College, Pennsylvania, United States
Penn State Psychological Clinic
🇺🇸
State College, Pennsylvania, United States