Partnering for Student Wellness

Study Overview
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Brief Summary
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This study will evaluate whether the evidence-based Clinical Services Supports (CSS) framework paired with an evidence-based Patient Centered Enhancement (PCE) compared to CSS alone will improve middle school students' social, emotional/behavioral, and academic functioning.

Detailed Description
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The mental health needs of children and youth are well-documented as an under-addressed and significant public health need in the United States. A number of barriers prevent children, youth, and families from accessing behavioral health services in standard clinic settings, including lack of sufficient transportation, cost, and stigma related to receiving services. School behavioral health (SBH) programs-in which community mental health providers join school teams to better address the social, emotional/behavioral, and academic needs of students-are growing in the United States because of their ability to reach youth who need, but may not otherwise receive, services. However, these efforts are limited by a lack of patient and stakeholder engagement. This has commonly resulted in SBH programs not being implemented, implemented inconsistently, or underutilized. The study will compare an evidence-based Patient-Centered Enhancements (PCE) intervention added to an evidence-based framework termed Clinical Services Supports (CSS) in a three-year intervention for students in middle schools. Investigators predict the addition of the PCE intervention will improve school climate and enhance SBH services, resulting in significantly improved social, emotional/behavioral, and academic outcomes in students. The study has three aims: Investigators will evaluate the extent to which PCE increases the number of students and families receiving school behavioral health services and expressing satisfaction with services received. Investigators will evaluate the impact of PCE on students' social, emotional/behavioral, and academic outcomes throughout the course of the intervention period (sixth through eighth grade). Investigators will evaluate the follow-up effects of PCE on social, emotional/behavioral, and academic outcomes and risk behaviors in a sample of students followed into high school.

Official Title
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Patient Centered Enhancements in School Behavioral Health: A Randomized Trial

Conditions
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Mental Health

Intervention / Treatment
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* Behavioral: Clinical Services Support
* Behavioral: Patient Centered Enhancements


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Middle school student Receives school-based behavioral health services Parent of a middle school student Parent of a student receiving school-based behavioral health services Enrolled in a participating school Exclusion Criteria: Not a middle school student Not receiving school-based behavioral health services Not a parent of a middle school student Does not have a child receiving school-based behavioral health services Not enrolled in a participating school
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clinical Services Support Condition<br>Participants in this condition will receive school-based behavioral health services from clinicians who are trained in the evidence-based Clinical Services Support (CSS) Framework. | Behavioral: Clinical Services Support<br>* The CSS framework packages together evidence-based practices of family engagement, modular evidence-based practice, quality assurance, and implementation support. Depending on their time of enrollment, participants can be involved in this condition for one to three years. They will be asked to complete assessments during their therapy sessions periodically throughout the trial.<br>|
| Experimental: Patient-Centered Enhancements<br>Participants in this condition will receive school-based behavioral health services from clinicians who are trained in the evidence-based Clinical Services Support (CSS) Framework. The clinicians in this condition will receive additional training on two Patient-Centered Enhancements (PCE). | Behavioral: Patient Centered Enhancements<br>* The two PCEs are: enhancing mental health literacy and stigma reduction, and improving family-school-mental health partnerships. Depending on their time of enrollment, participants can be involved in this condition for one to three years. They will be asked to complete assessments during their therapy sessions periodically throughout the trial.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in academic grades | Quarterly academic grades for ELA, math, social studies, and science | Baseline (summer before intervention), mid-treatment (annually for three years of intervention), post-treatment (one year after intervention) | 
| Change in academic attendance rates | Quarterly attendance (tardy and absence); including date, type of attendance (excused, unexcused), and reason for absence or tardy (if applicable) | Baseline (summer before intervention), mid-treatment (annually for three years of intervention), post-treatment (one year after intervention) | 
| Change in discipline rates | Quarterly discipline; including date, reason for office discipline referral, consequence as a result of the referral, and length of the consequence (if applicable) | Baseline (summer before intervention), mid-treatment (annually for three years of intervention), post-treatment (one year after intervention) | 
| Change in perceptions of school climate | School Climate Survey (SCS): a free, online climate survey from the US Department of Education. The SCS is a 73-item questionnaire for students and an 83-item questionnaire for school staff on a 4 point scale ranging from 1 Strongly Agree to 4 Strongly Disagree. | Baseline (summer before intervention), mid-treatment (annually for three years of intervention), post-treatment (one year after intervention) | 
| Change in access to services | Number of sessions conducted by the clinician in categories of assessment; individual, group, and family therapy; case management; and teacher consultation | Baseline (summer before intervention), mid-treatment (annually for three years of intervention) | 
| Change in client satisfaction with services | Client Satisfaction Questionnaire-8 (CSQ-8): 8-item measure for youth 11 and older and adults to assess individual's satisfaction with counseling services. The items range from 1 Poor to 4 Excellent. | Mid-treatment (through three years of intervention, an average of 3 per year) | 
| Change in social functioning of students receiving services | Child and Adolescent Social and Adaptive Functioning Scale (CASAFS): 24-item measure on school performance, peer relations, family relations, and home duties/self-care. The items range from 1 Never to 4 Always. For some items, a 5th option Does not apply to me is available. | Baseline (intake), mid-treatment (through three years of intervention, an average of 3 per year), post-treatment (one year after intervention) | 
| Change in emotional/behavioral functioning of students receiving services | Brief Problem Checklist: 12-item questionnaire measuring externalizing and internalizing problems. The Brief Problem Checklist ranges from 1 Not True to 3 Very True. | Baseline (intake), mid-treatment (through three years of intervention, an average of 3 per year), post-treatment (one year after intervention) | 
| Determine emergent risk behavior of students receiving services | Youth Risk Behavior Survey (YRBS): developed by the Centers for Disease Control and Prevention. The YRBS is a 58 item scale. The items in the survey do not have one consistent scale. Example scales are: 1 Never to 5 Always 1 0 times to 5 6 or more times 1 0 days to 7 All 30 days 1 0 days to 5 6 or more days 1 0 times to 8 12 or more times 1 Yes to 2 No 1 0 times to 7 100 or more times 1 0 times to 6 40 or more times 1 0 times to 3 2 or more times 1 I did not (insert activity; e.g., drive a car, drink alcohol, have intercourse) during the past 30 days to 6 6 or more times | Post-treatment (one year after intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mental health knowledge and perceived stigma | The Guide Curriculum Assessment (GSA): utilizing two subscales: Mental Health Knowledge (30 items; 1 True to 3 Don't know), Perceived Stigma (12 items; 1 Strongly Agree to 7 Strongly Disagree) | Baseline (intake), mid-treatment (through three years of intervention, an average of 3 per year) | 
| Change in family-school-community partnerships | SBH Quality Assessment Tool (SBHQAT) is a tool to assess the overall standard of services and supports provided in a school. The SBHQAT is a 5-item assessment with items ranging from 1 Not in place to 6 Fully in place | Mid-treatment (beginning and end of the school year for three years of intervention) | 
| Change in family-school-community partnerships | Therapeutic Alliance Scale for Children-revised (TASC) is a twelve item scale from 1 Not true to 4 Very much true measuring the client-therapist relationship. | Baseline (intake), mid-treatment (through three years of intervention, an average of 3 per year) | 
| Change in family-school-community partnerships | Parent Participation Engagement Measure is a 5 item measure with items ranging from 0 Not applicable to 5 Very much. | Baseline (intake), mid-treatment (through three years of intervention, an average of 3 per year) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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School-based services, Stakeholder Engagement, Middle School