Partnering for Student Wellness (PSW)

January 3, 2024 updated by: Mark Weist, University of South Carolina

Patient Centered Enhancements in School Behavioral Health: A Randomized Trial

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.

Study Overview

Detailed Description

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:

  1. 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.
  2. 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).
  3. 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.

Study Type

Interventional

Enrollment (Actual)

1279

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Baltimore
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Columbia, South Carolina, United States, 29208
        • University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Clinical Services Support Condition
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 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.
Experimental: Patient-Centered Enhancements
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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in academic grades
Time Frame: Baseline (summer before intervention), mid-treatment (annually for three years of intervention), post-treatment (one year after intervention)
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
Time Frame: Baseline (summer before intervention), mid-treatment (annually for three years of intervention), post-treatment (one year after intervention)
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
Time Frame: Baseline (summer before intervention), mid-treatment (annually for three years of intervention), post-treatment (one year after intervention)
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
Time Frame: Baseline (summer before intervention), mid-treatment (annually for three years of intervention), post-treatment (one year after intervention)
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
Time Frame: Baseline (summer before intervention), mid-treatment (annually for three years of intervention)
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
Time Frame: Mid-treatment (through three years of intervention, an average of 3 per year)
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
Time Frame: Baseline (intake), mid-treatment (through three years of intervention, an average of 3 per year), post-treatment (one year after intervention)
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
Time Frame: Baseline (intake), mid-treatment (through three years of intervention, an average of 3 per year), post-treatment (one year after intervention)
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
Time Frame: Post-treatment (one year after intervention)

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
Time Frame: Baseline (intake), mid-treatment (through three years of intervention, an average of 3 per year)
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
Time Frame: Mid-treatment (beginning and end of the school year for three years of intervention)
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
Time Frame: Baseline (intake), mid-treatment (through three years of intervention, an average of 3 per year)
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
Time Frame: Baseline (intake), mid-treatment (through three years of intervention, an average of 3 per year)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mark Weist, Ph.D., University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2019

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

March 29, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (Actual)

April 3, 2019

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00085951

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mental Health

Clinical Trials on Clinical Services Support

3
Subscribe