Clinical trial NCT05039164: Evaluation of a Remote Training Strategy
Official title: Evaluation of a Remote Training Strategy for School Personnel
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Behavior Disorders
Keywords: Positive-behavior Interventions and Supports
Evidence-based Practices
Tier 2
Mental Health
Rural Schools
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Devereux Center for Effective Schools
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2021-09-09
Enrollment: 408
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: An increasing number of schools in rural settings are employing the multi-tier positive behavioral interventions and supports (PBIS) framework to improve school-climate. PBIS can also be used as a framework for the adoption and integration of evidence-based practices (EBPs) for children's mental health concerns. A key challenge is that school personnel need technical assistance (training plus ongoing consultation) in order to implement EBPs with fidelity. In urban and suburban schools, this support can be provided to school staff on site. However, providing ongoing on-site support is not feasible or sustainable in the majority of rural schools, due to their remote physical location. For this reason, video technology has been recommended for the training of behavioral health staff (BHS) in under-served rural communities.

Detailed description: Objectives: The purpose of this study is to test the effectiveness of a remote training platform with BHS in schools serving rural communities.

Study Design: This study is a pilot randomized controlled trial to compare implementation and student outcomes of three training strategies: Control Condition (CC), Remote Video (RV), and Remote Video plus Coaching (RV+).

Setting/Participants: Participants will be school personnel with and without prior mental health training and students in grades 4-8 in schools serving rural communities who are deemed at risk for externalizing and internalizing mental health disorders. The pilot trial will be conducted in 24 schools (8 in CC, 8 in RV, and 8 in RV+). It is estimated that a total of 72 behavioral health staff (3 staff per school- 24 per arm) and 312 students (13 students per school - 104 per arm) will participate in this study. Additionally, we estimate about 24 school administrators such as principals or assistant principals will approve school's participation.

Study Interventions and Measures: Each school will be randomly assigned to receive one of three training supports: (a) Initial training (CC) (b) Initial training, plus video (RV) or (c) Initial training plus video, plus remote coaching (RV+). BHS in the RV+ condition will receive consultation from a Children's Hospital of Philadelphia (CHOP) consultant regarding implementation of EBPs, whereas BHS in the RV condition will be given access to the asynchronous training video modules. Participants in all three conditions will receive treatment manuals for the interventions they have chosen. The EBPs to be implemented by the BHS include: Coping Power Program (CPP), CBT for Anxiety Treatment in Schools (CATS), and Check-in/Check-out (CI/CO). All BHS will conduct one CPP or CATS group with 5 students of similar developmental level (e.g., a group of 4th \& 5th graders), and that each school staff in CI/CO will implement the intervention with 4 separate individual students of any eligible school grade.

Analyses: This study is designed to test the effectiveness of initial training compared to remote video training and remote video training plus coaching to train BHS to implement EBPs.

Eligibility criteria: Inclusion Criteria:

Administrator: Any school principal or assistant principal from participating schools implementing PBIS.

Behavioral Health Staff: Any counselor, social worker, or teacher from participating schools implementing PBIS who work with students in grades 4-8.

Students: Inclusion of students to receive a Tier 2 intervention is as follows:

* attending one of the participating schools
* being in grades 4-8
* identified by the Tier 2 team as not responding to Tier 1 intervention, thus needing Tier 2 support
* scoring ≥ 1 SD above the mean on the Emotional Symptoms or Conduct Problems scales of the Strength andDifficulties Questionnaire (SDQ) completed by a parent or a teacher

The cut-off score level for the SDQ is appropriate for identifying students at risk for a behavioral/mental health disorder. We limit participation to students in grades 4-8 because the group EBPs are appropriate for this age group.

Exclusion Criteria:

Administrator: School staff who are not principals or assistant principals.

Behavioral Health Staff: School staff who are not part of the PBIS team and who do not work with students in grades 4-8.

Students: Students who do not meet screening or group participation criteria will not be included in the study. Students with a history of intellectual disability or serious developmental delays according to school records will not be included because they would be unlikely to benefit from the interventions used in the study. Students with a history of psychotic or autistic spectrum disorders as reported by parents will not be included.

Subjects that do not meet all the enrollment criteria may not be enrolled. Any violations of these criteria must be reported in accordance with the Institutional Review Board (IRB) Policies and Procedures.

Primary outcomes:
measure: Measures of content fidelity for group cognitive-behavioral treatment (GCBT)
timeFrame: Up to 3 years
measure: Measures of content fidelity for Check-in, Check-Out
timeFrame: Up to 3 years
measure: Measures of process fidelity
timeFrame: Up to 3 years
measure: Perceived adoption and penetration
timeFrame: Up to 3 years
measure: Changes in student mental health symptoms from Baseline to Post Intervention
timeFrame: Baseline and 14 weeks (post intervention)
measure: Changes in academic engagement from Baseline to Post Intervention
timeFrame: Baseline and 14 weeks (post intervention)
measure: Changes in externalizing and internalizing problems
timeFrame: Baseline and 14 weeks (post intervention)
Secondary outcomes:
measure: Perceived mediators and moderators of consultation support
timeFrame: Up to 3 years
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 B Eiraldi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eiraldi R, McCurdy BL, Khanna MS, Goldstein J, Comly R, Francisco J, Rutherford LE, Wilson T, Henson K, Farmer T, Jawad AF. Development and evaluation of a remote training strategy for the implementation of mental health evidence-based practices in rural schools: pilot study protocol. Pilot Feasibility Stud. 2022 Jun 17;8(1):128. doi: 10.1186/s40814-022-01082-4.