- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03901274
Patient Centered Enhancements in School Behavioral Health (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 (i.e., Partnership) intervention added to an evidence-based framework termed Wellness in a three-year intervention for students in middle schools. Investigators predict the addition of the Partnership 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 Partnership increases the number of students and families receiving school behavioral health services and expressing satisfaction with services received.
- Investigators will evaluate the impact of Partnership on students' social, emotional/behavioral, and academic outcomes throughout the course of the intervention period (sixth through eighth grade).
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 |
|---|---|
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Active Comparator: Wellness Condition
Participants in this condition will receive school-based behavioral health services from clinicians who are trained in the evidence-based Wellness Framework.
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The Wellness 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: Partnership
Participants in this condition will receive school-based behavioral health services from clinicians who are trained in the evidence-based Wellness framework.
The clinicians in this condition will receive additional training on patient-centered enhancements called the Partnership intervention.
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The two patient-centered enhancements 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 Emotional/Behavioral Functioning of Students Receiving Services
Time Frame: Baseline (intake) and at 3 months and 6 months post-intake
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Brief Problem Checklist: 12-item questionnaire measuring externalizing and internalizing problems found in children age 7-13 years old.
Responses are given using a 3-point Likert scale ranging from 0 (not true) to 2 (very true), with responses summed for a possible score ranging from 0 to 24. High scores indicate a worse outcome for respondents.
Analysis included students who completed at least 80% of the items on the scale.
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Baseline (intake) and at 3 months and 6 months post-intake
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Change in Discipline Rates
Time Frame: Annually per academic year
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Computed models for student referrals to in-school suspension (ISS).
The primary estimate can be interpreted as the log count difference between the treatment and control, and the zero inflated parameter can be interpreted as the log odds of not belonging to the inflated zero latent class.
The primary analysis answers the question "Did random assignment to the Partnership condition change the number of observed behaviors?"
and the zero inflated parameter asks "Did random assignment to the Partnership condition change the odds of having any observed behaviors?".
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Annually per academic year
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Change in Perceptions of School Climate
Time Frame: Once annually, spring of each intervention year (2020, 2021, 2022, 2023)
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School Climate Survey (SCS): a free, online climate survey from the US Department of Education (ED). The SCS is a 73-item questionnaire for students and an 83-item questionnaire for school instructional and non-instructional staff on a 4 point scale ranging from 1 "Strongly Agree" to 4 "Strongly Disagree". School-level data were analyzed using ED School Climate Surveys (EDSCLS) platform which produces a benchmarked scale score. The benchmarked scale scores were created using item parameters based on a Rasch model. The EDSCLS produced scores which may fall into one of three categories:
Additional information on the benchmark scale score calculation is available at safesupportivelearning.ed.gov/edscls/benchmarks |
Once annually, spring of each intervention year (2020, 2021, 2022, 2023)
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Change in Access to Services
Time Frame: Duration of study enrollment from intake to study exit (average 6 months)
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Average number of clinical sessions per student during study enrollment, divided by type (in-person and via tele-health)
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Duration of study enrollment from intake to study exit (average 6 months)
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Change in Client Satisfaction With Services
Time Frame: At 3 months and 6 months post-intake
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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.
Responses are given using a Likert scales ranging from 1 (indicating poor quality or dissatisfaction with service) to 4 (excellent or highly satisfied with service).
Responses were summed for a possible score ranging from 8 to 32; with high scores indicating greater levels of satisfaction for respondents.
Analysis included students who completed at least 80% of the items on the scale.
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At 3 months and 6 months post-intake
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Change in Social Functioning of Students Receiving Services
Time Frame: Baseline (intake) and at 3 months and 6 months post-intake
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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 0 "Never" to 3 "Always".
For some items, "Does not apply to me" is an optional response.
Scores were summed for a possible range of 0 to 72, and respondents with at least 80% of items answered were included in analysis.
Several items on the instrument required reverse coding prior to analysis.
For this scale, lower scores indicate worse outcomes.
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Baseline (intake) and at 3 months and 6 months post-intake
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Change in Therapeutic Alliance
Time Frame: Baseline (intake), and 3 months and 6 months post-intake
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Therapeutic Alliance Scale for Children-revised (TASC) is a twelve item scale measuring the therapeutic alliance across treatment.
The scale is a 12-item, 4-point Likert scale, with responses ranging from 0 "not like me" to 3 "very much like me".
Five items on the scale required reverse coding prior to analysis.
The total score is the sum of all items, ranging from 0 to 48, where higher scores mean stronger therapeutic alliance (better outcomes).
Survey data were collected at 3- and 6-months post intake.
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Baseline (intake), and 3 months and 6 months post-intake
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Change in Academic Attendance Rates
Time Frame: Annual following each school year (2019-2020, 2020-2021, 2021-2022, and 2022-2023)
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School-level variable representing average number of days absent for all students in grades 6-8.
The average is calculated by dividing the number of days absent by the total number of days in the school year (180).
Note: attendance data are drastically skewed due to the impact of COVID-19.
Many schools around the country, including those in one participating district, offered remote-only instruction (no in-person learning) during the 2020-2021 school year; thus the concept of "absence" from school was distorted.
Therefore data presented here during 2019-2020 and 2020-2021 may not be meaningfully interpreted.
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Annual following each school year (2019-2020, 2020-2021, 2021-2022, and 2022-2023)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Mental Health Knowledge
Time Frame: Baseline (intake), and 3 months and 6 months post-intake
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The Guide Curriculum Assessment (GCA): Mental Health Knowledge scale includes 14 true-false questions related to mental health.
These items were scored based on the number of correct answers (0 to 14), where higher scores means more correct answers.
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Baseline (intake), and 3 months and 6 months post-intake
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Change in Perceived Stigma
Time Frame: Baseline (intake), 3 months post intake, and 6 months post intake
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The Guide Curriculum Assessment (GCA): Perceived Stigma scale includes 12 items with responses on a 7-point Likert scale from 1 "strongly agree" to 4 "not sure" to 7 "strongly disagree".
Two items require reverse coding.
Lower scores on this scale mean more stigma and higher scores are optimal, indicating less mental health stigma.
Scores on this scale range from 12 (most stigma) to 84 (least stigma).
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Baseline (intake), 3 months post intake, and 6 months post intake
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Change in Family-school-community Partnerships
Time Frame: At 3 months and 6 months post-intake
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Parent Participation Engagement Measure is a 5-item measure of parent participation in therapy sessions, with responses on a 5-point Likert scale ranging from 1 "not at all" to 5 "very much"; and where 0 indicates "not applicable".
Scores on this scale can range from 0 to 25 with higher scores indicating higher rates of parent engagement.
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At 3 months and 6 months post-intake
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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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Pro00085951
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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