NCT05034198

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

4.8 years

First QC Date

September 1, 2021

Last Update Submit

February 16, 2026

Conditions

Keywords

Positive-behavior Interventions and SupportsEvidence-based PracticesTier 2Mental HealthRural Schools

Outcome Measures

Primary Outcomes (5)

  • Content Fidelity of Cognitive Behavioral Therapy (CBT) for Anxiety Treatment in Schools (CATS) Implementation

    The Cognitive Behavioral Therapy (CBT) for Anxiety Treatment in Schools (CATS) Content Fidelity Checklist (CFC) measures implementer adherence to required components of each CATS group session based on audio-recorded sessions. A separate 4-item checklist is completed for each of the eight CATS sessions, with session-specific items scored using a yes/no format to indicate whether required content was delivered. Fidelity is calculated as the percentage of items scored "Yes" out of the total items on the checklist/expected, with scores ranging from 0% to 100%. Higher scores indicate greater fidelity of implementation.

    Across the 8-session CATS intervention period (approximately 8 weeks)

  • Content Fidelity of Coping Power Program (CPP) Implementation

    The Coping Power Program (CPP) Content Fidelity Checklist (CFC) measures implementer adherence to required components of each CPP group session based on audio-recorded sessions. A separate checklist is completed for each of the 12 CPP sessions, with session-specific items (ranging from 4 to 8 items depending on the session) scored using a yes/no format to indicate whether required content was delivered. Fidelity is calculated as the percentage of items scored "Yes" out of the total items on the checklist, with scores ranging from 0% to 100%. Higher scores indicate greater fidelity of implementation.

    Across the 12-session CPP intervention period (approximately 12 weeks)

  • Process Fidelity of Cognitive Behavioral Therapy (CBT) for Anxiety Treatment in Schools (CATS) and Coping Power Program (CPP) Implementation

    The Process Fidelity Checklist (PFC) measures the quality of intervention delivery during the Cognitive Behavioral Therapy (CBT) for Anxiety Treatment in Schools (CATS) and Coping Power Program (CPP) group sessions, including organization, use of active learning strategies, clarity of presentation, engagement of students, and relevance of examples. The checklist includes 10 items rated on a 0 to 5 scale (0=Not at all to 5=Very Often). Scores are calculated as the mean rating across items and sessions, with possible scores ranging from 0 to 5. Higher scores indicate greater fidelity of implementation.

    Across intervention session periods (approximately 8 to 12 weeks of intervention delivery)

  • Content and Process Fidelity of Check-In/Check-Out (CICO) Implementation

    The Implementation Guide Fidelity Checklist (IGF) - Content and Process measure assesses both content and process fidelity of implementation of the Check-In/Check-Out (CICO) intervention. Content fidelity is assessed using 40 items scored as "Yes," "No," or "Not Applicable" across key components (e.g., roles, logistics, motivation system, training, and data monitoring). Content fidelity scores are calculated as the percentage of items scored "Yes" out of applicable items (excluding "Not Applicable"), ranging from 0% to 100%, with higher percentages indicating greater adherence. Within the same checklist, process fidelity is assessed using quality indicator items rated 0 to 3 reflecting the comprehensiveness, clarity, and feasibility of implementation procedures. Process fidelity scores are calculated as the average quality rating across items, ranging from 0 to 3. Higher scores indicate greater fidelity of implementation.

    Once, at the completion of Check-In/Check-Out (CICO) implementation guide development (within the first year of implementation)

  • Penetration of Cognitive Behavioral Therapy (CBT) for Anxiety Treatment in Schools (CATS) and Coping Power Program (CPP) Implementation

    The Penetration Inventory (PI) is an Excel tracking tool used to document teacher referrals for Cognitive Behavioral Therapy (CBT) for Anxiety Treatment in Schools (CATS) and Coping Power Program (CPP) interventions among students in grades 4-8 and the number of students who received one of the evidence-based practices (EBPs). Penetration is calculated as the proportion of referred students who received an EBP, expressed as a percentage, with higher scores indicating greater penetration of Tier 2 services.

    Throughout the intervention implementation period (up to approximately 5 years from study start)

Secondary Outcomes (3)

  • Change in Behavioral and Emotional Functioning (The Behavior Assessment System for Children, Third Edition [BASC-3])

    From pre-intervention to post-intervention (approximately 8-12 weeks)

  • Change in Behavioral and Emotional Symptoms (Behavior and Feelings Scale - Youth Self-Report)

    From pre-intervention to post-intervention (approximately 8-12 weeks)

  • Change in Student Academic Engagement (Engagement Versus Disaffection with Learning - Teacher Report [EvsD-TR])

    From pre-intervention to post-intervention (approximately 8-12 weeks)

Other Outcomes (4)

  • Acceptability of Remote Training Strategy (Acceptability of Intervention Measure [AIM])

    Immediately after review of training modules during the pre-trial prototype evaluation phase (approximately 4 months after study start)

  • Appropriateness of Remote Training Strategy (Intervention Appropriateness Measure [IAM])

    Immediately after review of training modules during the pre-trial prototype evaluation phase (approximately 4 months after study start)

  • Feasibility of Remote Training Strategy (Feasibility of Intervention Measure [FIM])

    Immediately after review of training modules during the pre-trial prototype evaluation phase (approximately 4 months after study start)

  • +1 more other outcomes

Study Arms (3)

Video (TV)

ACTIVE COMPARATOR

Behavioral health staff (BHS, intervention implementers) received an initial synchronous and asynchronous training and ongoing access to asynchronous videos of intervention implementation.

Behavioral: Coping Power Program (CPP)Behavioral: Cognitive behavioral therapy (CBT) for Anxiety Treatment in Schools (CATS)Behavioral: Check-in/Check-out (CI/CO)

Video Plus Consultation (TVC)

ACTIVE COMPARATOR

BHS (intervention implementers) received an initial synchronous and asynchronous training, ongoing access to asynchronous videos of intervention implementation, and regular synchronous consultation from project staff.

Behavioral: Coping Power Program (CPP)Behavioral: Cognitive behavioral therapy (CBT) for Anxiety Treatment in Schools (CATS)Behavioral: Check-in/Check-out (CI/CO)

Control Condition (T)

ACTIVE COMPARATOR

BHS (intervention implementers) received an initial synchronous and asynchronous training only.

Behavioral: Coping Power Program (CPP)Behavioral: Cognitive behavioral therapy (CBT) for Anxiety Treatment in Schools (CATS)Behavioral: Check-in/Check-out (CI/CO)

Interventions

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.

Control Condition (T)Video (TV)Video Plus Consultation (TVC)

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.

Control Condition (T)Video (TV)Video Plus Consultation (TVC)

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.

Control Condition (T)Video (TV)Video Plus Consultation (TVC)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Phase 2 (pilot RCT)
  • 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:
  • 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 and Difficulties Questionnaire (SDQ) 54 completed by a parent or a teacher (determined based on existing literature and demographic for which EBP was designed)
  • 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. 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 because these interventions are not appropriate for that demographic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Mental DisordersPsychological Well-Being

Interventions

Cognitive Behavioral TherapySchools

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesNon-Medical Public and Private Facilities

Study Officials

  • Ricardo Eiraldi, PhD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Phase 1: Using semi-structured interviews, we obtain input from school behavioral health staff to gather feedback about the feasibility, acceptability, and the appropriateness of the remote training strategies being developed. Phase 2: Informed by preliminary studies and Phase/Aim 1 data, we developed a synchronous (interactive) and asynchronous (non-interactive) remote training strategy. We implemented these training protocols through a pilot randomized controlled trial, whereby participating schools were randomized to one of three conditions: (a) initial remote (synchronous) training, (b) initial remote (synchronous) training, plus access to asynchronous training videos, or (C) initial remote (synchronous) training, access to asynchronous training video, plus synchronous remote coaching.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2021

First Posted

September 5, 2021

Study Start

September 30, 2020

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations