Patient Centered Enhancements in School Behavioral Health

NCT ID: NCT03901274

Last Updated: 2025-06-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2558 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-10

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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\' social, emotional/behavioral, and academic functioning.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mental Health

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Wellness Condition

Participants in this condition will receive school-based behavioral health services from clinicians who are trained in the evidence-based Wellness Framework.

Group Type ACTIVE_COMPARATOR

Wellness

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Partnership

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Wellness

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.

Intervention Type BEHAVIORAL

Partnership

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role collaborator

University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mark Weist

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mark Weist, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Maryland, Baltimore

Baltimore, Maryland, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

University of South Carolina

Columbia, South Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 26720827 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25551789 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26520104 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10245370 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11845643 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20658809 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7900725 (View on PubMed)

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.

Reference Type BACKGROUND

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00085951

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Evaluating the Hope@School Prevention Program
NCT06359262 NOT_YET_RECRUITING NA
Multisite Prevention of Conduct Problems (Fast Track)
NCT01653535 ACTIVE_NOT_RECRUITING NA