Sustainment of Mental Health Supports

Behavior Disorders Clinical Trial

Official title:

Sustainment of Mental Health Supports in Under-Resourced Urban Schools

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04869657
• Other study ID #: 20-018185
• Secondary ID: 1R01MH122465-01A
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 17, 2021
• Est. completion date: January 2026

Study information

• Verified date: November 2023
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 494
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior Disorders
• Mental Disorders

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Institute of Mental Health (NIMH), University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 14 weeks
Primary	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.	3 years
Primary	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.	Baseline and 14 weeks (post -intervention)
Primary	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).	Baseline and 14 weeks (post-intervention)
Primary	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.	up to 5 years