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

Study Overview
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Brief Summary
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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

Official Title
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Confirmatory Efficacy of the Building a Strong Identity and Coping Skills Program for Low-income and Minoritized Young Adolescents

Conditions
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Chronic Stress, Anxiety, Depression

Intervention / Treatment
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* Behavioral: Building a Strong Identity and Coping Skills


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BaSICS Intervention<br>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. | Behavioral: Building a Strong Identity and Coping Skills<br>* Psychoeducational program to teach children coping skills, healthy identity development, and collective social action<br>* Other names: BaSICS;|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Poverty, Discrimination, Stress, Coping