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Behavior DisordersNCT05034198

Remote Training in Rural Schools

A study testing Coping Power Program (CPP), Cognitive behavioral therapy (CBT) for Anxiety Treatment in Schools (CATS) and Check-in/Check-out (CI/CO) in people with Behavior Disorders, run by Children's Hospital of Philadelphia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Behavior Disorders
What is being tested?
Coping Power Program (CPP), Cognitive behavioral therapy (CBT) for Anxiety Treatment in Schools (CATS) and Check-in/Check-out (CI/CO)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
1 siteUnited States
Study dates
30 Sep 2020to 1 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Development and Pilot Testing of a Remote Training Strategy for the Implementation of Mental Health Evidence-Based Practices in Rural Schools

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.

Being tested
Coping Power Program (CPP), Cognitive behavioral therapy (CBT) for Anxiety Treatment in Schools (CATS), Check-in/Check-out (CI/CO)
Keywords
Positive-behavior Interventions and Supports, Evidence-based Practices, Tier 2, Mental Health, Rural Schools
Medical subject headings
Mental Disorders, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coping Power Program (CPP)Behavioural

    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)Behavioural

    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)Behavioural

    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.

Study groups in NCT05034198
Study groupRoleWhat they receive
Video (TV)Active comparatorBehavioral health staff (BHS, intervention implementers) received an initial synchronous and asynchronous training and ongoing access to asynchronous videos of intervention implementation.
Receives: 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 comparatorBHS (intervention implementers) received an initial synchronous and asynchronous training, ongoing access to asynchronous videos of intervention implementation, and regular synchronous consultation from project staff.
Receives: 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 comparatorBHS (intervention implementers) received an initial synchronous and asynchronous training only.
Receives: Behavioral: Coping Power Program (CPP); Behavioral: Cognitive behavioral therapy (CBT) for Anxiety Treatment in Schools (CATS); Behavioral: Check-in/Check-out (CI/CO)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

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

    The Behavior Assessment System for Children, Third Edition (BASC-3) parent report measures children's and adolescents' behavioral and emotional functioning. Scores are reported as standardized T-scores, with higher scores indicating greater behavioral or emotional problems. Parents/caregivers completed the BASC-3 at pre-intervention and post-intervention to assess change over time.

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

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

    The Behavior and Feelings Survey (BFS) - Youth Self-Report measures youths' behavioral and emotional symptoms. Possible scores range from 0 to 48 on the total score, with higher scores indicating greater symptom severity. Students completed the BFS at pre-intervention and post-intervention to assess change over time.

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

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

    The Engagement Versus Disaffection with Learning - Teacher Report (EvsD-TR) measures students' academic engagement and disaffection in the classroom. The instrument includes four subscales: Behavioral Engagement, Emotional Engagement, Behavioral Disaffection, and Emotional Disaffection. Each subscale score ranges from 5 to 20, with higher scores indicating greater levels of the respective construct (engagement or disaffection). Teachers completed the EvsD-TR at pre-intervention and post-intervention to assess change in academic engagement over time.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2021
  2. Study start30 Sep 2020
  3. Primary completion1 Jul 2025
  4. Study completion1 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05034198
Sponsor's protocol ID
20-017895
Other IDs
R18HS027755
Status last verified
Feb 2026
First submitted
1 Sep 2021
Last updated
19 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35710520

Questions about this trial

What is this clinical trial studying?

A study testing Coping Power Program (CPP), Cognitive behavioral therapy (CBT) for Anxiety Treatment in Schools (CATS) and Check-in/Check-out (CI/CO) in people with Behavior Disorders, run by Children's Hospital of Philadelphia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Content Fidelity of Cognitive Behavioral Therapy (CBT) for Anxiety Treatment in Schools (CATS) Implementation (time frame: Across the 8-session CATS intervention period (approximately 8 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05034198, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.

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