Skip to main content
OpenTrials
Completed

NCT Number: NCT03901274

Patient Centered Enhancements in School Behavioral Health

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland, Baltimore, Baltimore, Maryland, United States

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Emotional/Behavioral Functioning of Students Receiving Services

    Time frame: Baseline (intake) and at 3 months and 6 months post-intake

    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.

  2. Change in Discipline Rates

    Time frame: Annually per academic year

    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?".

  3. Change in Perceptions of School Climate

    Time frame: Once annually, spring of each intervention year (2020, 2021, 2022, 2023)

    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

  4. Change in Access to Services

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

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

  5. Change in Client Satisfaction With Services

    Time frame: At 3 months and 6 months post-intake

    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.

  6. Change in Social Functioning of Students Receiving Services

    Time frame: Baseline (intake) and at 3 months and 6 months post-intake

    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.

  7. Change in Therapeutic Alliance

    Time frame: Baseline (intake), and 3 months and 6 months post-intake

    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.

  8. Change in Academic Attendance Rates

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

    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.

Secondary outcomes

  1. Change in Mental Health Knowledge

    Time frame: Baseline (intake), and 3 months and 6 months post-intake

    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.

  2. Change in Perceived Stigma

    Time frame: Baseline (intake), 3 months post intake, and 6 months post intake

    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).

  3. Change in Family-school-community Partnerships

    Time frame: At 3 months and 6 months post-intake

    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.

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

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

Registry information

Official study title

Patient Centered Enhancements in School Behavioral Health: A Randomized Trial

Acronym: PSW

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 3, 2019
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.