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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05034198
Other study ID # 20-017895
Secondary ID R18HS027755
Status Completed
Phase N/A
First received
Last updated
Start date September 30, 2020
Est. completion date September 30, 2022

Study information

Verified date October 2023
Source Children's Hospital of Philadelphia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Rural areas have fewer, and less well trained, health care providers than non-rural areas. Schools have become more involved in the delivery of mental health services and hold great potential for increasing access to children and adolescents. Innovations in training and service delivery are needed to improve mental health care quality and availability in rural schools. Evidence-based practices (EBPs) can be incorporated into school-wide multi-tiered systems that are currently used to improve school climate and safety. School-wide Positive Behavioral Interventions and Supports (PBIS), a service-delivery strategy based on the public health model is one example. Investigators will use an iterative process (Rapid Prototyping) to develop and evaluate the appropriateness, feasibility, acceptability, and preliminary efficacy of a remote training strategy that provides resources to support use of Tier 2 EBPs and effective support for care coordination practices in rural schools.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date September 30, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: Any BHS (e.g., school counselor, school social worker or teacher who is under employment from a school district) based at a school implementing PBIS and who may be nominated by the principal as a potential participant is eligible to be included in the study. Additionally, the research staff will reach out to school behavioral health staff concurrently with the school principal. BHS staff will provide consent to participate. Exclusion Criteria: Staff from schools not implementing PBIS.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Coping Power Program (CPP)
CPP is an evidence-based intervention designed for students with externalizing behavior disorder. CPP consists of twelve 45-minute sessions. This EBP has been found to be effective at reducing aggressive behavior, covert delinquent behavior and substance abuse among aggressive boys, with gains maintained at one-year follow-up. Growth curve analyses showed that CPP had linear effects for three years after intervention on reductions in aggressive behavior and academic behavior problems.
Cognitive behavioral therapy (CBT) for Anxiety Treatment in Schools (CATS)
CATS is an adaptation of Friends for Life (FRIENDS). The adapted protocol retains the core elements of evidence-based CBT for anxiety and the FRIENDS group format. Investigators implemented planned adaptations to the protocol based on collective experience. Changes were made to the language, cultural methods, number of sessions, and activities while maintaining the 5 essential components of the treatment. This resulted in a briefer (8-session) and more feasible, engaging and culturally appropriate protocol for urban under-resourced schools than the original FRIENDS.
Check-in/Check-out (CI/CO)
CI/CO is a targeted, Tier 2 intervention for students at risk of developing externalizing and internalizing mental health disorders. CI/CO is designed to provide immediate feedback (i.e., at the end of each class period) to students, based on the use of a daily report card. This feedback is developmentally sensitive. CI/CO implementers meet individually with students for a brief 'check-in' in the morning and a brief 'check-out' in the afternoon. Research on the use of CI/CO has shown it to be effective in reducing externalizing and internalizing problems with elementary school students. CI/CO will be offered to individual students for a three-month period of time, which is the same time-frame needed for the implementation of CPP.

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
Children's Hospital of Philadelphia Agency for Healthcare Research and Quality (AHRQ), Devereux Center for Effective Schools

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stakeholder Input Semi-structured interviews and surveys will be conducted with stakeholders to determine efficacy of a universal strategies that provides resources to support evidence-based practices (EBPs) for implementing appropriate behavioral care coordination practices for students in rural schools in Pennsylvania. Up to 2 years
Primary Asynchronous Training Platform Development A Rapid prototyping approach will be used to develop non-interactive, remote training strategy (RTS) using on-demand, pre-recorded training videos for school personnel in rural schools based on preliminary studies and Aim 1 data. Up to 2 years
Primary Synchronous Training Platform Development A Rapid prototyping approach will be used to develop a remote training strategy (RTS) consisting of virtual meetings for school personnel in rural schools based on preliminary studies and Aim 1 data Up to 2 years
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