Back to resultsSustainment of Mental Health Supports
Primary Purpose
Behavior Disorders
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coaches with Children's Hospital of Philadelphia (CHOP) Research Consultant Support
Coaches without CHOP Research Consultant Support
Sponsored by
About this trial
This is an interventional health services research trial for Behavior Disorders
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
Sites / Locations
- Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sustainment 1: Coaches with CHOP Support
Sustainment 2: Coaches without CHOP Support
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Fidelity to Tier 2 Interventions Checklists
Fidelity will be measured every time a student receives a Tier 2 intervention. All Tier 2 team meetings and child group Tier 2 sessions will be audio-recorded. These recordings will be used to determine content fidelity using the Coping Power, CATS and Check-In/Check-Out Content Fidelity Checklists.
Penetration of Evidence-Based Practices (EBP)
Investigators will assess EBP penetration at the school provider level (behavioral health staff involved in the implementation of EBPs), and at the student service level (students receiving EBPs at Tier 2) during Years 2 and 3 of the study compared to Year 1.This information will be obtained from questionnaires completed by school therapists and their coaches.
Change in the Behavior Assessment System for Children (BASC) from Baseline to Post Intervention
Student Mental Health Symptoms will be measured by comparing parental and child scores pre-intervention and post-intervention.The BASC-3 is a 138-item, 4-point, Likert-type rating scale (N=Never, S=Sometimes, O=Often, A=Almost Always) for assessing parental report of child mental health functioning, standardized for ages 2.5 to 18 years.
Change in the Engagement versus Disaffection with Learning from Baseline to Post Intervention.
Student Academic Engagement will be measured by comparing teacher and student scores pre-intervention and post-intervention.This is a 20-item, four-point instrument (1 = Not At All True, 2 = Not Very True, 3 = Sort Of True, 4 = Very True) with four sub-scales. Investigators will use the average score for each of the four scales at pre- and post-participation in group cognitive behavioral therapy (CBT) or Check-in/Check-out (CICO).
Cost-effectiveness
A Cost Benefit Analysis will be conducted across both sustainment conditions, comparing material expenses, personnel effort, agency and school district salaries, etc. Cost-effective will be measured using qualitative interviews with staff participants.
Secondary Outcome Measures
Full Information
NCT ID
NCT04869657
First Posted
April 23, 2021
Last Updated
October 3, 2022
Sponsor
Children's Hospital of Philadelphia
Collaborators
University of Pennsylvania, National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT04869657
Brief Title
Sustainment of Mental Health Supports
Official Title
Sustainment of Mental Health Supports in Under-Resourced Urban Schools
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 17, 2021 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
University of Pennsylvania, National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior Disorders
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
505 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sustainment 1: Coaches with CHOP Support
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sustainment 2: Coaches without CHOP Support
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Coaches with Children's Hospital of Philadelphia (CHOP) Research Consultant Support
Intervention Description
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
Intervention Name(s)
Coaches without CHOP Research Consultant Support
Intervention Description
Coaches employed by the school district will support the implementation of three evidence-based practices without any additional support from CHOP research consultants.
Primary Outcome Measure Information:
Title
Fidelity to Tier 2 Interventions Checklists
Description
Fidelity will be measured every time a student receives a Tier 2 intervention. All Tier 2 team meetings and child group Tier 2 sessions will be audio-recorded. These recordings will be used to determine content fidelity using the Coping Power, CATS and Check-In/Check-Out Content Fidelity Checklists.
Time Frame
Up to 14 weeks
Title
Penetration of Evidence-Based Practices (EBP)
Description
Investigators will assess EBP penetration at the school provider level (behavioral health staff involved in the implementation of EBPs), and at the student service level (students receiving EBPs at Tier 2) during Years 2 and 3 of the study compared to Year 1.This information will be obtained from questionnaires completed by school therapists and their coaches.
Time Frame
3 years
Title
Change in the Behavior Assessment System for Children (BASC) from Baseline to Post Intervention
Description
Student Mental Health Symptoms will be measured by comparing parental and child scores pre-intervention and post-intervention.The BASC-3 is a 138-item, 4-point, Likert-type rating scale (N=Never, S=Sometimes, O=Often, A=Almost Always) for assessing parental report of child mental health functioning, standardized for ages 2.5 to 18 years.
Time Frame
Baseline and 14 weeks (post -intervention)
Title
Change in the Engagement versus Disaffection with Learning from Baseline to Post Intervention.
Description
Student Academic Engagement will be measured by comparing teacher and student scores pre-intervention and post-intervention.This is a 20-item, four-point instrument (1 = Not At All True, 2 = Not Very True, 3 = Sort Of True, 4 = Very True) with four sub-scales. Investigators will use the average score for each of the four scales at pre- and post-participation in group cognitive behavioral therapy (CBT) or Check-in/Check-out (CICO).
Time Frame
Baseline and 14 weeks (post-intervention)
Title
Cost-effectiveness
Description
A Cost Benefit Analysis will be conducted across both sustainment conditions, comparing material expenses, personnel effort, agency and school district salaries, etc. Cost-effective will be measured using qualitative interviews with staff participants.
Time Frame
up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo Eiraldi, PhD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35130964
Citation
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.
Results Reference
derived
Learn more about this trial
Sustainment of Mental Health Supports
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