Clinical trial NCT03901274: Patient Centered Enhancements in School Behavioral Health
Official title: Patient Centered Enhancements in School Behavioral Health: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Keywords: School-based services
Stakeholder Engagement
Middle School
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: University of Maryland, Baltimore
name: Medical University of South Carolina
First posted: 2019-04-03
Enrollment: 2558
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate whether the evidence-based Wellness framework paired with an evidence-based Partnership compared to Wellness alone will improve middle school students\&#39; social, emotional/behavioral, and academic functioning.

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:

1. 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.
2. 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).

Eligibility 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

Primary outcomes:
measure: Change in Emotional/Behavioral Functioning of Students Receiving Services
timeFrame: Baseline (intake) and at 3 months and 6 months post-intake
measure: Change in Discipline Rates
timeFrame: Annually per academic year
measure: Change in Perceptions of School Climate
timeFrame: Once annually, spring of each intervention year (2020, 2021, 2022, 2023)
measure: Change in Access to Services
timeFrame: Duration of study enrollment from intake to study exit (average 6 months)
measure: Change in Client Satisfaction With Services
timeFrame: At 3 months and 6 months post-intake
measure: Change in Social Functioning of Students Receiving Services
timeFrame: Baseline (intake) and at 3 months and 6 months post-intake
measure: Change in Therapeutic Alliance
timeFrame: Baseline (intake), and 3 months and 6 months post-intake
measure: Change in Academic Attendance Rates
timeFrame: Annual following each school year (2019-2020, 2020-2021, 2021-2022, and 2022-2023)
Secondary outcomes:
measure: Change in Mental Health Knowledge
timeFrame: Baseline (intake), and 3 months and 6 months post-intake
measure: Change in Perceived Stigma
timeFrame: Baseline (intake), 3 months post intake, and 6 months post intake
measure: Change in Family-school-community Partnerships
timeFrame: At 3 months and 6 months post-intake
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Mark Weist, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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