Sustainment of Mental Health Supports

NCT04869657 | Completed DMC

• 2 other identifiers: 20-0181851R01MH122465-01A1
• Study Type: interventional
• Target: 421
• Locations: 1 country
• Sites: 1

Brief 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. 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 \[CATS\]).

Conditions

Behavior Disorders

Keywords

Sustainability; Implementation; Effectiveness; Multitiered Systems of Supports; Evidence-Based Pracices; Urban schools; Mental health; Training

Outcome Measures

Primary Outcomes (8)

• 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.

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

• 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.

  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

  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

  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

  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])

  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])

  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])

  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)

Study Arms (2)

Sustainment 1: Coaches with CHOP Support

ACTIVE COMPARATOR

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); Behavioral: Cognitive behavioral therapy (CBT) for Anxiety Treatment in Schools (CATS)

Sustainment 2: Coaches without CHOP Support

ACTIVE COMPARATOR

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); Behavioral: Cognitive behavioral therapy (CBT) for Anxiety Treatment in Schools (CATS)

Interventions

Coping Power Program (CPP) BEHAVIORAL

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.

Sustainment 1: Coaches with CHOP Support; Sustainment 2: Coaches without CHOP Support

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

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.

Sustainment 1: Coaches with CHOP Support; Sustainment 2: Coaches without CHOP Support

Eligibility Criteria

• Age: 8 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• University of Pennsylvania: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

Related Publications (1)

• 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.

  PMID: 35130964 DERIVED

MeSH Terms

Conditions

Mental Disorders; Psychological Well-Being

Interventions

Cognitive Behavioral Therapy; Schools

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Non-Medical Public and Private Facilities

Study Officials

• Ricardo Eiraldi, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: May 3, 2021
• Study Start: September 17, 2021
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)