Sustainment of Mental Health Supports

February 16, 2026 updated by: Children's Hospital of Philadelphia

Sustainment of Mental Health Supports in Under-Resourced Urban Schools

Schools need sustainable systems to improve climate and address student mental health. This study compares two sustainment models for Tier 2 mental health interventions within a Positive Behavioral Interventions and Support (PBIS) framework. Using a 2-arm, cluster randomized Type-2 Hybrid trial, 12 urban public schools participated over three years each. School district intervention Implementers (e.g., school counselors) and district-level coaches participated throughout the study, while Tier 2 Team Members (e.g., social workers, behavioral health staff) were involved during the initial implementation phase only. Primary outcomes include fidelity, penetration, cost, and student outcomes (mental health and academic engagement) for evidence-based practices (Coping Power Program [CPP]; Cognitive Behavioral Therapy [CBT] for Anxiety Treatment in Schools [CATS]).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
421

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19146
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Schools: Any school in the participating urban, public school district already implementing Positive Behavioral Interventions and Supports (PBIS).
  • Tier 2 Team Members: Any staff from participating schools involved in the PBIS leadership team at that school.
  • Tier 2 Implementers: Any Masters-level staff assigned by their school's principal to deliver Tier 2 interventions.
  • Tier 2 Coaches: Any Masters-level clinician employed by the school district to support staff implementing Tier 2 interventions
  • Students: Any student at participating schools in grades 4-8 who scores above > 1 standard deviation (SD) above the mean on the Emotional Symptoms or Conduct Problems scales of the Strengths and Difficulties Questionnaire (SDQ), plus Impact Supplement scores of 1 (A medium amount) or 2 (A great deal), completed by a parent or a teacher. Then, based on the student's score (Emotional Symptoms=internalizing symptoms, Conduct Problems=externalizing symptoms), the teacher must complete the Social, Academic, and Emotional Behavioral Risk Screener (SAEBRS), which is the school district's standard screening criteria for Tier 2 services for externalizing behaviors, or the child must complete the Screen for Child Anxiety Related Disorders (SCARED) for interlaizing behaviors. Based on these scores, the student is eligible to enroll in the intervention.

Exclusion Criteria:

  • Schools: Any schools not currently implementing PBIS at Tier 1.
  • Tier 2 Team Members and Implementers: Any school personnel that are not involved in the leadership team or Tier 2 team.
  • Students: Any student with a Special Education classification of "Intellectual Disability," or with a history of psychotic or autistic spectrum disorders, according to school records, will be excluded because they would be unlikely to benefit from our Tier 2 interventions, as they were not designed for these demographics.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Sustainment 1: Coaches with CHOP Support
In Year 1, schools in both arms will receive Tier 2 intervention support from Children's Hospital of Philadelphia (CHOP) research consultants. In Year 2, schools in Sustainment 1 will receive reduced support from school district coaches, who will themselves receive diminished support from research consultants. In Year 3, schools in both conditions will implement Tier 2 interventions with support from school district coaches only, with no direct consultant involvement.
Behavioral: Coping Power Program (CPP)
CPP is an evidence-based intervention designed for students with externalizing behavior disorder. CPP consists of twelve 45-minute sessions. This EBP has been found to be effective at reducing aggressive behavior, covert delinquent behavior and substance abuse among aggressive boys, with gains maintained at one-year follow-up. Growth curve analyses showed that CPP had linear effects for three years after intervention on reductions in aggressive behavior and academic behavior problems.
Behavioral: Cognitive behavioral therapy (CBT) for Anxiety Treatment in Schools (CATS)
CATS is an adaptation of the Friends for Life (FRIENDS) intervention. The adapted protocol retains the core elements of evidence-based CBT for anxiety and the FRIENDS group format. Investigators implemented planned adaptations to the protocol based on collective experience. Changes were made to the language, cultural methods, number of sessions, and activities while maintaining the 5 essential components of the treatment. This resulted in a briefer (8-session) and more feasible, engaging, and culturally appropriate protocol for urban under-resourced schools than the original FRIENDS.
Active Comparator: Sustainment 2: Coaches without CHOP Support
In Year 1, schools in both arms will receive Tier 2 intervention support from CHOP research consultants. In Years 2 and 3, schools in Sustainment 2 will receive support from school district coaches only; coaches will not receive assistance from research consultants.
Behavioral: Coping Power Program (CPP)
CPP is an evidence-based intervention designed for students with externalizing behavior disorder. CPP consists of twelve 45-minute sessions. This EBP has been found to be effective at reducing aggressive behavior, covert delinquent behavior and substance abuse among aggressive boys, with gains maintained at one-year follow-up. Growth curve analyses showed that CPP had linear effects for three years after intervention on reductions in aggressive behavior and academic behavior problems.
Behavioral: Cognitive behavioral therapy (CBT) for Anxiety Treatment in Schools (CATS)
CATS is an adaptation of the Friends for Life (FRIENDS) intervention. The adapted protocol retains the core elements of evidence-based CBT for anxiety and the FRIENDS group format. Investigators implemented planned adaptations to the protocol based on collective experience. Changes were made to the language, cultural methods, number of sessions, and activities while maintaining the 5 essential components of the treatment. This resulted in a briefer (8-session) and more feasible, engaging, and culturally appropriate protocol for urban under-resourced schools than the original FRIENDS.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Content Fidelity of Cognitive Behavioral Therapy (CBT) for Anxiety Treatment in Schools (CATS) Implementation
Time Frame: Across the 8-session CATS intervention period (approximately 8 weeks)
The Cognitive Behavioral Therapy (CBT) for Anxiety Treatment in Schools (CATS) Content Fidelity Checklist (CFC) measures implementer adherence to required components of each CATS group session based on audio-recorded sessions. A separate 4-item checklist is completed for each of the eight CATS sessions, with session-specific items scored using a yes/no format to indicate whether required content was delivered. Fidelity is calculated as the percentage of items scored "Yes" out of the total items on the checklist/expected, with scores ranging from 0% to 100%. Higher scores indicate greater fidelity of implementation.
Across the 8-session CATS intervention period (approximately 8 weeks)
Content Fidelity of Coping Power Program (CPP) Implementation
Time Frame: Across the 12-session CPP intervention period (approximately 12 weeks)
The Coping Power Program (CPP) Content Fidelity Checklist (CFC) measures implementer adherence to required components of each CPP group session based on audio-recorded sessions. A separate checklist is completed for each of the 12 CPP sessions, with session-specific items (ranging from 4 to 8 items depending on the session) scored using a yes/no format to indicate whether required content was delivered. Fidelity is calculated as the percentage of items scored "Yes" out of the total items on the checklist, with scores ranging from 0% to 100%. Higher scores indicate greater fidelity of implementation.
Across the 12-session CPP intervention period (approximately 12 weeks)
Process Fidelity of Cognitive Behavioral Therapy (CBT) for Anxiety Treatment in Schools (CATS) and Coping Power Program (CPP) Implementation
Time Frame: Across intervention session periods (approximately 8 to 12 weeks of intervention delivery)
The Process Fidelity Checklist (PFC) measures the quality of intervention delivery during the Cognitive Behavioral Therapy (CBT) for Anxiety Treatment in Schools (CATS) and Coping Power Program (CPP) group sessions, including organization, use of active learning strategies, clarity of presentation, engagement of students, and relevance of examples. The checklist includes 10 items rated on a 0 to 5 scale (0=Not at all to 5=Very Often). Scores are calculated as the mean rating across items and sessions, with possible scores ranging from 0 to 5. Higher scores indicate greater fidelity of implementation.
Across intervention session periods (approximately 8 to 12 weeks of intervention delivery)
Penetration of Cognitive Behavioral Therapy (CBT) for Anxiety Treatment in Schools (CATS) and Coping Power Program (CPP) Implementation
Time Frame: Throughout the intervention implementation period (up to approximately 4 years from study start)
The Penetration Inventory (PI) is an Excel tracking tool used to document teacher referrals for Cognitive Behavioral Therapy (CBT) for Anxiety Treatment in Schools (CATS) and Coping Power Program (CPP) interventions among students in grades 4-8 and the number of students who received one of the evidence-based practices (EBPs). Penetration is calculated as the proportion of referred students who received an EBP, expressed as a percentage, with higher scores indicating greater penetration of Tier 2 services.
Throughout the intervention implementation period (up to approximately 4 years from study start)
Personnel Cost of Sustainment Strategies for Cognitive Behavioral Therapy (CBT) for Anxiety Treatment in Schools (CATS) and Coping Power Program (CPP) Interventions
Time Frame: Throughout the implementation period (timesheets completed approximately 3-4 times per year, up to approximately 4 years)
Total personnel cost associated with intervention implementation, based on staff-reported time spent on intervention- and study-related activities (including training, consultation, intervention preparation and delivery, assessment/documentation, and travel). Personnel time was collected using timesheets completed approximately 3-4 times per year, and costs were estimated using salary and benefit information from school district administrative data. Higher costs indicate greater personnel resources required to implement the sustainment strategy.
Throughout the implementation period (timesheets completed approximately 3-4 times per year, up to approximately 4 years)
Change in Behavioral and Emotional Functioning (The Behavior Assessment System for Children, Third Edition [BASC-3])
Time Frame: From pre-intervention to post-intervention (approximately 8-12 weeks)
The Behavior Assessment System for Children, Third Edition (BASC-3) parent report measures children's and adolescents' behavioral and emotional functioning. Scores are reported as standardized T-scores, with higher scores indicating greater behavioral or emotional problems. Parents/caregivers completed the BASC-3 at pre-intervention and post-intervention to assess change over time.
From pre-intervention to post-intervention (approximately 8-12 weeks)
Change in Behavioral and Emotional Symptoms (Behavior and Feelings Scale - Youth Self-Report [BFS])
Time Frame: From pre-intervention to post-intervention (approximately 8-12 weeks)
The Behavior and Feelings Survey (BFS) - Youth Self-Report measures youths' behavioral and emotional symptoms. Possible scores range from 0 to 48 on the total score, with higher scores indicating greater symptom severity. Students completed the BFS at pre-intervention and post-intervention to assess change over time.
From pre-intervention to post-intervention (approximately 8-12 weeks)
Change in Student Academic Engagement (Engagement Versus Disaffection with Learning - Teacher and Student Report [EvsD-TR/SR])
Time Frame: From pre-intervention to post-intervention (approximately 8-12 weeks)
The Engagement Versus Disaffection with Learning - Teacher Report (EvsD-TR) and Student Report (EvsD-SR) measure students' academic engagement and disaffection in the classroom. The instrument includes four subscales: Behavioral Engagement, Emotional Engagement, Behavioral Disaffection, and Emotional Disaffection. Each subscale score ranges from 5 to 20, with higher scores indicating greater levels of the respective construct (engagement or disaffection). Teachers completed the EvsD-TR, and students completed the EvsD-SR at pre-intervention and post-intervention to assess change in academic engagement over time.
From pre-intervention to post-intervention (approximately 8-12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Philadelphia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
University of Pennsylvania

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ricardo Eiraldi, PhD, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 17, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-018185
  • 1R01MH122465-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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