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ClinicalTrials.gov Identifier: NCT03901274
Recruitment Status : Enrolling by invitation
First Posted : April 3, 2019
Last Update Posted : December 11, 2019
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
University of Maryland, Baltimore
Medical University of South Carolina
Information provided by (Responsible Party):
Mark Weist, University of South Carolina

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mental Health Behavioral: Clinical Services Support Behavioral: Patient Centered Enhancements Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient Centered Enhancements in School Behavioral Health: A Randomized Trial
Actual Study Start Date : September 10, 2019
Estimated Primary Completion Date : February 15, 2024
Estimated Study Completion Date : April 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

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.
Behavioral: Clinical Services Support
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).
Behavioral: Patient Centered Enhancements
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.




Primary Outcome Measures :
  1. 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

  2. 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)

  3. 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)

  4. 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".

  5. 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

  6. 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".

  7. 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.

  8. 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".

  9. 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"


Secondary Outcome Measures :
  1. 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")

  2. 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"

  3. 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.

  4. 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".



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03901274


Locations
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United States, Maryland
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
University of South Carolina
Columbia, South Carolina, United States, 29208
Sponsors and Collaborators
University of South Carolina
Patient-Centered Outcomes Research Institute
University of Maryland, Baltimore
Medical University of South Carolina
Investigators
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Principal Investigator: Mark Weist, Ph.D. University of South Carolina

Additional Information:
Publications:
Connors, E.H., Stephan, S.H., Lever, N., Ereshefsky, S., Mosby, A., & Bohnenkamp, J. (2016). A national initiative to advance school mental health performance measurement in the US. Advances in School Mental Health Promotion, 9(1), 50-69.
Weist, M.D., Sander, M.A., Walrath, C., Link, B., Nabors, L., Adelsheim, S., ... & Carrillo, K. (2005). Developing principles for best practice in expanded school mental health. Journal of Youth and Adolescence, 34(1), 7-13.
Abrishami, G.F. & Warren, J.S. (2013). Therapeutic alliance and outcomes in children and adolescents served in a community mental health system. Journal of Child & Adolescent Behavior, 1(2), 1-7.

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Responsible Party: Mark Weist, Professor, University of South Carolina
ClinicalTrials.gov Identifier: NCT03901274    
Other Study ID Numbers: Pro00085951
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mark Weist, University of South Carolina:
School-based services
Stakeholder Engagement
Middle School