Sustainment of Mental Health Supports

NCT ID: NCT04869657

Last Updated: 2025-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 392 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-17
• Study Completion Date: 2025-07-01

Brief Summary

Schools are in great need of service delivery systems that can improve school climate and also attend to students' mental health. One effective approach is Positive Behavioral Interventions and Supports (PBIS), a multitiered framework for defining and organizing practices and interventions (including mental health practices).

Conditions

Behavior Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Sustainment 1: Coaches with CHOP Support

In Year 1 of participation, schools in both arms will receive support for Tier 2 interventions provided by Children's Hospital of Philadelphia (CHOP) research consultants. In Year 2, schools in Sustainment 1 will receive reduced support for Tier 2 interventions provided by school district coaches. The coaches will in turn receive diminished support from research consultants. In Year 3, schools in both conditions will implement Tier 2 interventions with support from school district coaches; coaches will not receive direct assistance from research consultants.

Group Type: ACTIVE_COMPARATOR

Coaches with Children's Hospital of Philadelphia (CHOP) Research Consultant Support

Intervention Type: BEHAVIORAL

Coaches employed by the school district will support the implementation of three evidence-based practices, while themselves being remotely supported by CHOP research consultants.

Coaches without CHOP Research Consultant Support

Intervention Type: BEHAVIORAL

Coaches employed by the school district will support the implementation of three evidence-based practices without any additional support from CHOP research consultants.

Sustainment 2: Coaches without CHOP Support

In Year 1 of participation, schools in both arms will receive support for Tier 2 interventions provided by CHOP research consultants. In Years 2 and 3, schools in Sustainment 2 will receive support from school district coaches but coaches will not receive help from research consultants.

Group Type: ACTIVE_COMPARATOR

Coaches without CHOP Research Consultant Support

Intervention Type: BEHAVIORAL

Coaches employed by the school district will support the implementation of three evidence-based practices without any additional support from CHOP research consultants.

Interventions

Coaches with Children's Hospital of Philadelphia (CHOP) Research Consultant Support

Coaches employed by the school district will support the implementation of three evidence-based practices, while themselves being remotely supported by CHOP research consultants.

Intervention Type: BEHAVIORAL

Coaches without CHOP Research Consultant Support

Coaches employed by the school district will support the implementation of three evidence-based practices without any additional support from CHOP research consultants.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Schools: Any school in the School District of Philadelphia (SDP) 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 SDP to support staff implementing Tier 2 interventions
• Students: Any student at participating schools in grades 4-8 who scores as eligible for PBIS based on the Social, Academic, and Emotional Behavioral Risk Screener (SAEBRS), which is standard screening criteria in the SDP for Tier 2 services and scores above > 1 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

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ricardo Eiraldi, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35130964 (View on PubMed)

Other Identifiers

1R01MH122465-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-018185

Identifier Type: -

Identifier Source: org_study_id