Patient Centered Enhancements in School Behavioral Health

NCT03901274 | Completed Results

• 1 other identifier: Pro00085951
• Study Type: interventional
• Target: 2,558
• Locations: 1 country
• Sites: 3

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

Conditions

Mental Health

Keywords

School-based services; Stakeholder Engagement; Middle School

Outcome Measures

Primary Outcomes (8)

• Change in Emotional/Behavioral Functioning of Students Receiving Services

  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.

  Baseline (intake) and at 3 months and 6 months post-intake

• Change in Discipline Rates

  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?".

  Annually per academic year

• Change in Perceptions of School Climate

  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: * Least Favorable (scores below 300) * Favorable (scores 300-400) * Most Favorable (scores above 400-500) 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)

• Change in Access to Services

  Average number of clinical sessions per student during study enrollment, divided by type (in-person and via tele-health)

  Duration of study enrollment from intake to study exit (average 6 months)

• Change in Client Satisfaction With Services

  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.

  At 3 months and 6 months post-intake

• Change in Social Functioning of Students Receiving Services

  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.

  Baseline (intake) and at 3 months and 6 months post-intake

• Change in Therapeutic Alliance

  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.

  Baseline (intake), and 3 months and 6 months post-intake

• Change in Academic Attendance Rates

  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.

  Annual following each school year (2019-2020, 2020-2021, 2021-2022, and 2022-2023)

Secondary Outcomes (3)

• Change in Mental Health Knowledge

  Baseline (intake), and 3 months and 6 months post-intake

• Change in Perceived Stigma

  Baseline (intake), 3 months post intake, and 6 months post intake

• Change in Family-school-community Partnerships

  At 3 months and 6 months post-intake

Study Arms (2)

Wellness Condition

ACTIVE COMPARATOR

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

Behavioral: Wellness

Partnership

EXPERIMENTAL

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.

Behavioral: Partnership

Interventions

Wellness 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.

Wellness Condition

Partnership 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.

Partnership

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Carolina: lead
• Patient-Centered Outcomes Research Institute: collaborator
• University of Maryland, Baltimore: collaborator
• Medical University of South Carolina: collaborator

Study Sites (3)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Related Publications (10)

• 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.

  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.

  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.

  PMID: 26720827 BACKGROUND

• 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.

  PMID: 25551789 BACKGROUND

• 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.

  PMID: 26520104 BACKGROUND

• 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.

  PMID: 10245370 BACKGROUND

• 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.

  PMID: 11845643 BACKGROUND

• 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.

  PMID: 20658809 BACKGROUND

• 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.

  PMID: 7900725 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Health

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Population Characteristics

Results Point of Contact

• Title: Dr. Mark Weist
• Organization: University of South Carolina

weist@mailbox.sc.edu

803-777-8438

Study Officials

• Mark Weist, Ph.D.

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 3, 2019
• Study Start: September 10, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 5, 2025
• Results First Posted: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)