Clinical trial NCT04869657: Sustainment of Mental Health Supports
Official title: Sustainment of Mental Health Supports in Under-Resourced Urban Schools
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Behavior Disorders
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: National Institute of Mental Health (NIMH)
First posted: 2021-05-03
Enrollment: 716
Sex: ALL
Minimum age (years): 8
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


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

Primary outcomes:
measure: Fidelity to Tier 2 Interventions Checklists
timeFrame: Up to 14 weeks
measure: Penetration of Evidence-Based Practices (EBP)
timeFrame: 3 years
measure: Change in the Behavior Assessment System for Children (BASC) from Baseline to Post Intervention
timeFrame: Baseline and 14 weeks (post -intervention)
measure: Change in the Engagement versus Disaffection with Learning from Baseline to Post Intervention.
timeFrame: Baseline and 14 weeks (post-intervention)
measure: Cost-effectiveness
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Ricardo Eiraldi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.