- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03901274
Partnering for Student Wellness (PSW)
Patient Centered Enhancements in School Behavioral Health: A Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland, Baltimore
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Columbia, South Carolina, United States, 29208
- University of South Carolina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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.
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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.
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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).
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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.
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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)
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Quarterly academic grades for ELA, math, social studies, and science
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Baseline (summer before intervention), mid-treatment (annually for three years of intervention), post-treatment (one year after intervention)
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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)
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Quarterly attendance (tardy and absence); including date, type of attendance (excused, unexcused), and reason for absence or tardy (if applicable)
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Baseline (summer before intervention), mid-treatment (annually for three years of intervention), post-treatment (one year after intervention)
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Change in discipline rates
Time Frame: Baseline (summer before intervention), mid-treatment (annually for three years of intervention), post-treatment (one year after intervention)
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Quarterly discipline; including date, reason for office discipline referral, consequence as a result of the referral, and length of the consequence (if applicable)
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Baseline (summer before intervention), mid-treatment (annually for three years of intervention), post-treatment (one year after intervention)
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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)
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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".
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Baseline (summer before intervention), mid-treatment (annually for three years of intervention), post-treatment (one year after intervention)
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Change in access to services
Time Frame: Baseline (summer before intervention), mid-treatment (annually for three years of intervention)
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Number of sessions conducted by the clinician in categories of assessment; individual, group, and family therapy; case management; and teacher consultation
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Baseline (summer before intervention), mid-treatment (annually for three years of intervention)
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Change in client satisfaction with services
Time Frame: Mid-treatment (through three years of intervention, an average of 3 per year)
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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".
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Mid-treatment (through three years of intervention, an average of 3 per year)
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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)
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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.
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Baseline (intake), mid-treatment (through three years of intervention, an average of 3 per year), post-treatment (one year after intervention)
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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)
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Brief Problem Checklist: 12-item questionnaire measuring externalizing and internalizing problems.
The Brief Problem Checklist ranges from 1 "Not True" to 3 "Very True".
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Baseline (intake), mid-treatment (through three years of intervention, an average of 3 per year), post-treatment (one year after intervention)
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Determine emergent risk behavior of students receiving services
Time Frame: Post-treatment (one year after intervention)
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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:
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Post-treatment (one year after intervention)
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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)
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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")
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Baseline (intake), mid-treatment (through three years of intervention, an average of 3 per year)
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Change in family-school-community partnerships
Time Frame: Mid-treatment (beginning and end of the school year for three years of intervention)
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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"
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Mid-treatment (beginning and end of the school year for three years of intervention)
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Change in family-school-community partnerships
Time Frame: Baseline (intake), mid-treatment (through three years of intervention, an average of 3 per year)
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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.
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Baseline (intake), mid-treatment (through three years of intervention, an average of 3 per year)
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Change in family-school-community partnerships
Time Frame: Baseline (intake), mid-treatment (through three years of intervention, an average of 3 per year)
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Parent Participation Engagement Measure is a 5 item measure with items ranging from 0 "Not applicable" to 5 "Very much".
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Baseline (intake), mid-treatment (through three years of intervention, an average of 3 per year)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark Weist, Ph.D., University of South Carolina
Publications and helpful links
General Publications
- Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.
- Chorpita BF, Reise S, Weisz JR, Grubbs K, Becker KD, Krull JL; Research Network on Youth Mental Health. Evaluation of the Brief Problem Checklist: child and caregiver interviews to measure clinical progress. J Consult Clin Psychol. 2010 Aug;78(4):526-36. doi: 10.1037/a0019602.
- 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.
- Kutcher S, Wei Y, Morgan C. Successful Application of a Canadian Mental Health Curriculum Resource by Usual Classroom Teachers in Significantly and Sustainably Improving Student Mental Health Literacy. Can J Psychiatry. 2015 Dec;60(12):580-6. doi: 10.1177/070674371506001209.
- Mcluckie A, Kutcher S, Wei Y, Weaver C. Sustained improvements in students' mental health literacy with use of a mental health curriculum in Canadian schools. BMC Psychiatry. 2014 Dec 31;14:379. doi: 10.1186/s12888-014-0379-4.
- Haine-Schlagel R, Roesch SC, Trask EV, Fawley-King K, Ganger WC, Aarons GA. The Parent Participation Engagement Measure (PPEM): Reliability and Validity in Child and Adolescent Community Mental Health Services. Adm Policy Ment Health. 2016 Sep;43(5):813-823. doi: 10.1007/s10488-015-0698-x.
- Price CS, Spence SH, Sheffield J, Donovan C. The development and psychometric properties of a measure of social and adaptive functioning for children and adolescents. J Clin Child Adolesc Psychol. 2002 Mar;31(1):111-22. doi: 10.1207/S15374424JCCP3101_13.
- Brener ND, Collins JL, Kann L, Warren CW, Williams BI. Reliability of the Youth Risk Behavior Survey Questionnaire. Am J Epidemiol. 1995 Mar 15;141(6):575-80. doi: 10.1093/oxfordjournals.aje.a117473.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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