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Behavior DisordersNCT04869657

Sustainment of Mental Health Supports

A study testing Coping Power Program (CPP) and Cognitive behavioral therapy (CBT) for Anxiety Treatment in Schools (CATS) in people with Behavior Disorders, run by Children's Hospital of Philadelphia at 1 site 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

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. Read more about this study

Who is it for?
Ages 8 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Behavior Disorders
What is being tested?
Coping Power Program (CPP) and Cognitive behavioral therapy (CBT) for Anxiety Treatment in Schools (CATS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
421 participants
Where
1 siteUnited States
Study dates
17 Sep 2021to 1 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

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 8 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19146

Other trials in United States

About this study

Official title: 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]).

Being tested
Coping Power Program (CPP), Cognitive behavioral therapy (CBT) for Anxiety Treatment in Schools (CATS)
Keywords
Sustainability, Implementation, Effectiveness, Multitiered Systems of Supports, Evidence-Based Pracices, Urban schools, Mental health, Training
Medical subject headings
Mental Disorders, Psychological Well-Being

What participants receive

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

  • Coping Power Program (CPP)Behavioural

    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.

  • Cognitive behavioral therapy (CBT) for Anxiety Treatment in Schools (CATS)Behavioural

    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.

Study groups in NCT04869657
Study groupRoleWhat they receive
Sustainment 1: Coaches with CHOP SupportActive comparatorIn 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.
Receives: Behavioral: Coping Power Program (CPP); Behavioral: Cognitive behavioral therapy (CBT) for Anxiety Treatment in Schools (CATS)
Sustainment 2: Coaches without CHOP SupportActive comparatorIn 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.
Receives: Behavioral: Coping Power Program (CPP); Behavioral: Cognitive behavioral therapy (CBT) for Anxiety Treatment in Schools (CATS)

What is being measured

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

  1. Content Fidelity of Cognitive Behavioral Therapy (CBT) for Anxiety Treatment in Schools (CATS) Implementation

    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.

    Measured: Across the 8-session CATS intervention period (approximately 8 weeks)

  2. Content Fidelity of Coping Power Program (CPP) Implementation

    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.

    Measured: Across the 12-session CPP intervention period (approximately 12 weeks)

  3. Process Fidelity of Cognitive Behavioral Therapy (CBT) for Anxiety Treatment in Schools (CATS) and Coping Power Program (CPP) Implementation

    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.

    Measured: Across intervention session periods (approximately 8 to 12 weeks of intervention delivery)

  4. Penetration of Cognitive Behavioral Therapy (CBT) for Anxiety Treatment in Schools (CATS) and Coping Power Program (CPP) Implementation

    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.

    Measured: Throughout the intervention implementation period (up to approximately 4 years from study start)

  5. Personnel Cost of Sustainment Strategies for Cognitive Behavioral Therapy (CBT) for Anxiety Treatment in Schools (CATS) and Coping Power Program (CPP) Interventions

    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.

    Measured: Throughout the implementation period (timesheets completed approximately 3-4 times per year, up to approximately 4 years)

  6. Change in Behavioral and Emotional Functioning (The Behavior Assessment System for Children, Third Edition [BASC-3])

    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.

    Measured: From pre-intervention to post-intervention (approximately 8-12 weeks)

  7. Change in Behavioral and Emotional Symptoms (Behavior and Feelings Scale - Youth Self-Report [BFS])

    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.

    Measured: From pre-intervention to post-intervention (approximately 8-12 weeks)

  8. Change in Student Academic Engagement (Engagement Versus Disaffection with Learning - Teacher and Student Report [EvsD-TR/SR])

    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.

    Measured: From pre-intervention to post-intervention (approximately 8-12 weeks)

Timeline

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

  1. First posted3 May 2021
  2. Study start17 Sep 2021
  3. Primary completion1 Jul 2025
  4. Study completion1 Jul 2025

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
421 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04869657
Sponsor's protocol ID
20-018185
Other IDs
1R01MH122465-01A1
Status last verified
Feb 2026
First submitted
23 Apr 2021
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Eiraldi R, Comly R, Wilson T, Khanna MS, Wolk CB, Bennett A, Henson K, Popkin KM, Brooks N, Bevenour P, Goldstein J, Jawad AF. Implementation and student outcomes of an implementation strategy for the sustainability of group evidence-based practices in schools. Res Sq [Preprint]. 2026 Jul 7:rs.3.rs-10164991. doi: 10.21203/rs.3.rs-10164991/v1.

    PubMed 42466386
  • Eiraldi R, McCurdy BL, Khanna MS, Wolk CB, Glick HA, Rabenau-McDonnell QA, Comly R, Rutherford LE, Banks J, Rufe SA, Popkin KM, Wilson T, Henson K, Wandersman A, Jawad AF. Study protocol: cluster randomized trial of consultation strategies for the sustainment of mental health interventions in under-resourced urban schools: rationale, design, and methods. BMC Psychol. 2022 Feb 7;10(1):24. doi: 10.1186/s40359-022-00733-8.

    PubMed 35130964

Questions about this trial

What is this clinical trial studying?

A study testing Coping Power Program (CPP) and Cognitive behavioral therapy (CBT) for Anxiety Treatment in Schools (CATS) in people with Behavior Disorders, run by Children's Hospital of Philadelphia at 1 site 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 3 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 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

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 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 NCT04869657, which also lists 2 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 18 Feb 2026.

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