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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BaSICS Intervention | Experimental | 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. |
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| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Building a Strong Identity and Coping Skills | Behavioral | Psychoeducational program to teach children coping skills, healthy identity development, and collective social action |
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| Measure | Description | Time Frame |
|---|---|---|
| Anxiety | 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). | Pre-post (3 months) and Pre-follow up (6 and 12 months) |
| Depression | 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. | Pre-post (3 months) and Pre-follow up (6 and 12 months) |
| Suicide Risk Markers | 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. | Pre-post (3 months) and Pre-follow up (6 and 12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Engagement Coping Skills Acquisition | 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). | Pre-post (3 months) and Pre-follow up (6 and 12 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martha E Wadsworth, PhD | Contact | 814-865-2878 | mew27@psu.edu | |
| Dara Babinksi, PhD | Contact | dbabinski@pennstatehealth.psu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Martha E Wadsworth, PhD | Penn State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennsylvania Psychiatric Institute | Not yet recruiting | Harrisburg | Pennsylvania | 17110 | United States |
All data produced in the course of the project will be preserved and shared after de-identification. Item level spreadsheet data for all variables will be shared openly once cleaned. Data will be deposited into the National Institute of Mental Health Data Archive.
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Data will become available after de-identification and cleaning.
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000097813 | Coping Skills |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| HPA Reactivity Profile |
Changes in levels of salivary cortisol across a 90-minute Trier Social Stress Test (TSST) protocol |
| Pre-post (3 months) and Pre-follow up (6 and 12 months) |
| Collaborative Coping | 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). | Pre-post (3 months) and Pre-follow up (6 and 12 months) |
| Sociocultural Identity Development | 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). | Pre-post (3 months) and Pre-follow up (6 and 12 months) |
| Penn State Health Medical Group - Psychiatry and Behavioral Health | Recruiting | Hershey | Pennsylvania | 17033 | United States |
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| Penns Valley Area School District | Not yet recruiting | Spring Mills | Pennsylvania | 16875 | United States |
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| Dr. Edwin L. Herr Clinic | Recruiting | State College | Pennsylvania | 16802 | United States |
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| Penn State Psychological Clinic | Recruiting | State College | Pennsylvania | 16802 | United States |
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