Mental HealthPSWNCT03901274

Patient Centered Enhancements in School Behavioral Health

A study testing Wellness and Partnership in people with Mental Health, run by University of South Carolina at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Mental Health
What is being tested?: Wellness and Partnership
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,558 participants
Where: 3 sitesUnited States
Study dates: 10 Sep 2019to 31 Dec 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

University of Maryland, Baltimore
Baltimore, Maryland, 21201
Medical University of South Carolina
Charleston, South Carolina, 29425
University of South Carolina
Columbia, South Carolina, 29208

Other trials in United States

About this study

Official title: Patient Centered Enhancements in School Behavioral Health: A Randomized Trial

Read the 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).

Conditions: Mental Health
Being tested: Wellness, Partnership
Keywords: School-based services, Stakeholder Engagement, Middle School
Medical subject headings: Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

WellnessBehavioural
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.
PartnershipBehavioural
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.

Study groups in NCT03901274
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Partnership

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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?".
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Annual following each school year (2019-2020, 2020-2021, 2021-2022, and 2022-2023)

Secondary outcomes (3)

Change in Mental Health Knowledge
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.
Measured: Baseline (intake), and 3 months and 6 months post-intake
Change in Perceived Stigma
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).
Measured: Baseline (intake), 3 months post intake, and 6 months post intake
Change in Family-school-community Partnerships
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.
Measured: At 3 months and 6 months post-intake

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Sep 201931 Dec 2023

First posted3 Apr 2019
Study start10 Sep 2019
Primary completion31 Dec 2023
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Mental HealthStudies of the same condition, open and under way.
More trials run by University of South CarolinaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 2,558 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03901274
Sponsor's protocol ID: Pro00085951
Acronym: PSW
Status last verified: May 2025
First submitted: 29 Mar 2019
Last updated: 5 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 26720827
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.
PubMed 25551789
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.
PubMed 26520104
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.
PubMed 10245370
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.
PubMed 11845643
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.
PubMed 20658809
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.
PubMed 7900725
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.
Weist MD, Patterson B, McQuillin SD, Fairchild AJ, Chehoski BE, Stevens RN, Haines C, Cox J, Chandler T, Hoover S, Reaves S, Lu Q, Obeid JS. Enhancing collaborative relationships and mental health literacy to improve school behavioral health for middle school students: a randomized controlled trial. BMC Public Health. 2026 Jul 1. doi: 10.1186/s12889-026-28047-z. Online ahead of print.
PubMed 42387471

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Patient Centered Enhancements in School Behavioral Health: A Randomized Trial
ClinicalTrials.gov ID: NCT03901274
Acronym / sponsor ID: PSW / Pro00085951
Conditions: Mental Health
Keywords: School-based services, Stakeholder Engagement, Middle School
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,558 participants (actual)
Lead sponsor: University of South CarolinaUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute, University of Maryland, Baltimore, Medical University of South Carolina
Study start: 10 Sep 2019 (actual)
Primary completion: 31 Dec 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 3 Apr 2019 (actual)
Results: Posted 5 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Wellness Condition	Active comparator	Behavioral: WellnessParticipants in this condition will receive school-based behavioral health services from clinicians who are trained in the evidence-based Wellness Framework.
Partnership	Experimental	Behavioral: PartnershipParticipants 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
WellnessThe 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.	Behavioural	Wellness Condition
PartnershipThe 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.	Behavioural	Partnership

Primary outcome

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.
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?".
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
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)
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.
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.
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.
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.

3 secondary outcomes

Change in Mental Health Knowledge
Time frame: Baseline (intake), and 3 months and 6 months post-intake
Change in Perceived Stigma
Time frame: Baseline (intake), 3 months post intake, and 6 months post intake
Change in Family-school-community Partnerships
Time frame: At 3 months and 6 months post-intake

Results and safety

Results posted to the registry on 5 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Wellness Condition	1,330	1,210
Partnership	1,228	1,098

Primary outcome: Change in Emotional/Behavioral Functioning of Students Receiving Services

Time frame: Baseline (intake) and at 3 months and 6 months post-intake. Mean (Standard Deviation). Unit: score on a scale

Measure	Wellness Condition n = 1146	Partnership n = 982
Intake-student	9.03 (4.82)	9.21 (4.71)
3 months post-student	8.86 (4.80)	8.94 (4.60)
6 months post-student	9.05 (4.93)	8.36 (4.70)
Intake-parent	8.48 (5.02)	8.97 (5.34)
3 months post-parent	7.15 (4.74)	8.42 (5.01)
6 months post-parent	7.12 (4.68)	7.63 (4.65)

Wellness Condition vs Partnership: Slope: -0.16 (95% CI -0.74 to 0.42)
Wellness Condition vs Partnership: Slope: -0.65 (95% CI -1.20 to -0.09)

Population analysed: Students and parents who responded to at least 80% of items on the measure at each timepoint were included for analysis.

Primary outcome: Change in Discipline Rates

Time frame: Annually per academic year. Number. Unit: participants

Measure	Wellness Condition n = 18653	Partnership n = 18652
2019-2020 school year	4646	4646
2020-2021 school year	4555	4554
2021-2022 school year	4633	4633
2022-2023 school year	4819	4819

Population analysed: This number includes all students who were enrolled at each of the 20 participating schools, not only those who were engaged in clinical practice. Students did not actively consent into this analysis of administrative school record data. Only a small fraction of the schoolwide population enrolled in the study to provide self-reported data on behaviors and clinical outcomes; whereas this analysis was of whole-school data.

Primary outcome: Change in Perceptions of School Climate

Time frame: Once annually, spring of each intervention year (2020, 2021, 2022, 2023). Mean (Standard Deviation). Unit: score on a scale

Measure	Wellness Condition n = 2590	Partnership n = 2284
Spring 2020 - student	289.8 (15.3)	297.5 (6.8)
Spring 2020- teacher	284.2 (30.8)	270.5 (27.3)
Spring 2020 - staff	282.6 (17.6)	281.0 (18.0)
Spring 2021 - student	267.9 (19.9)	283.6 (20.9)
Spring 2021 - teacher	258.8 (31.2)	250.7 (17.4)
Spring 2021 - staff	254.6 (16.6)	258.8 (9.4)
Spring 2022 - student	289.2 (14.9)	299.6 (23.6)
Spring 2022 - teacher	270.4 (19.5)	278.2 (14.4)

Population analysed: Participants in this outcome measure are schools, because this is a school-level variable. A total of 10 schools participated in each condition. In Spring 2020 and Spring 2021, only one school district participated due to the impact of the novel coronavirus pandemic and related transition to remote learning. In some cases, no teachers or staff responded to the invitation to participate (as indicated in participation numbers below).

Primary outcome: Change in Access to Services

Time frame: Duration of study enrollment from intake to study exit (average 6 months). Mean (Standard Deviation). Unit: total number of sessions

Measure	Wellness Condition n = 578	Partnership n = 505
In-person sessions	6.12 (7.82)	6.17 (6.71)
Telehealth sessions	.83 (2.88)	1.62 (4.83)

Population analysed: Number of students who participated in therapy (attended sessions with provider)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Enrollment into the study (for student self-reported data) was conducted on a rolling basis, beginning in September 2019. Enrollees completed surveys at three intervals: upon intake, three months post-intake, and six months post-intake. After enrollment concluded in June 2023, post-intake assessments were completed through December 2023.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Wellness Condition	0 of 665 (0%)	0 of 665 (0%)	0 of 665
Partnership	0 of 614 (0%)	0 of 614 (0%)	0 of 614

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundConnors, 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.
BackgroundWeist, 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: PubMed 26720827Kutcher 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.
Background: PubMed 25551789Mcluckie 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.
Background: PubMed 26520104Haine-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.
Background: PubMed 10245370Larsen 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.
Background: PubMed 11845643Price 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.
Background: PubMed 20658809Chorpita 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.
Background: PubMed 7900725Brener 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.
BackgroundAbrishami, 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.
Derived from this study: PubMed 42387471Weist MD, Patterson B, McQuillin SD, Fairchild AJ, Chehoski BE, Stevens RN, Haines C, Cox J, Chandler T, Hoover S, Reaves S, Lu Q, Obeid JS. Enhancing collaborative relationships and mental health literacy to improve school behavioral health for middle school students: a randomized controlled trial. BMC Public Health. 2026 Jul 1. doi: 10.1186/s12889-026-28047-z. Online ahead of print.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark Weist, Ph.D. principal investigator

University of South Carolina

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Wellness and Partnership in people with Mental Health, run by University of South Carolina at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Emotional/Behavioral Functioning of Students Receiving Services (time frame: Baseline (intake) and at 3 months and 6 months post-intake). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03901274, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.