- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05034198
Remote Training in Rural Schools
Development and Pilot Testing of a Remote Training Strategy for the Implementation of Mental Health Evidence-Based Practices in Rural Schools
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Phase 1 (semi-structured interviews and rapid prototyping) 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.
Phase 2 (pilot RCT)
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:
- 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)
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. 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Video (TV)
Behavioral health staff (BHS, intervention implementers) received an initial synchronous and asynchronous training and ongoing access to asynchronous videos of intervention implementation.
|
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.
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.
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.
|
|
Active Comparator: Video Plus Consultation (TVC)
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.
|
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.
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.
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.
|
|
Active Comparator: Control Condition (T)
BHS (intervention implementers) received an initial synchronous and asynchronous training only.
|
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 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.
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Across the 8-session CATS intervention period (approximately 8 weeks)
|
|
Content Fidelity of Coping Power Program (CPP) Implementation
Time Frame: Across the 12-session CPP intervention period (approximately 12 weeks)
|
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
Time Frame: Across intervention session periods (approximately 8 to 12 weeks of intervention delivery)
|
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
Time Frame: Once, at the completion of Check-In/Check-Out (CICO) implementation guide development (within the first year of 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)
|
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Penetration of Cognitive Behavioral Therapy (CBT) for Anxiety Treatment in Schools (CATS) and Coping Power Program (CPP) Implementation
Time Frame: Throughout the intervention implementation period (up to approximately 5 years from study start)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Behavioral and Emotional Functioning (The Behavior Assessment System for Children, Third Edition [BASC-3])
Time Frame: From pre-intervention to post-intervention (approximately 8-12 weeks)
|
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.
|
From pre-intervention to post-intervention (approximately 8-12 weeks)
|
|
Change in Behavioral and Emotional Symptoms (Behavior and Feelings Scale - Youth Self-Report)
Time Frame: From pre-intervention to post-intervention (approximately 8-12 weeks)
|
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.
|
From pre-intervention to post-intervention (approximately 8-12 weeks)
|
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Change in Student Academic Engagement (Engagement Versus Disaffection with Learning - Teacher Report [EvsD-TR])
Time Frame: From pre-intervention to post-intervention (approximately 8-12 weeks)
|
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.
|
From pre-intervention to post-intervention (approximately 8-12 weeks)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of Remote Training Strategy (Acceptability of Intervention Measure [AIM])
Time Frame: Immediately after review of training modules during the pre-trial prototype evaluation phase (approximately 4 months after study start)
|
The Acceptability of Intervention Measure (AIM) assesses perceived acceptability of the remote training strategy.
The AIM includes 4 items rated on a 1 to 5 scale, with total scores ranging from 4 to 20, and higher scores indicating greater acceptability of the training strategy.
|
Immediately after review of training modules during the pre-trial prototype evaluation phase (approximately 4 months after study start)
|
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Appropriateness of Remote Training Strategy (Intervention Appropriateness Measure [IAM])
Time Frame: Immediately after review of training modules during the pre-trial prototype evaluation phase (approximately 4 months after study start)
|
The Intervention Appropriateness Measure (IAM) assesses perceived appropriateness of the remote training strategy.
The IAM includes 4 items rated on a 1 to 5 scale, with total scores ranging from 4 to 20, and higher scores indicating greater perceived appropriateness.
|
Immediately after review of training modules during the pre-trial prototype evaluation phase (approximately 4 months after study start)
|
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Feasibility of Remote Training Strategy (Feasibility of Intervention Measure [FIM])
Time Frame: Immediately after review of training modules during the pre-trial prototype evaluation phase (approximately 4 months after study start)
|
The Feasibility of Intervention Measure (FIM) assesses perceived feasibility of the remote training strategy.
The FIM includes 4 items rated on a 1 to 5 scale, with total scores ranging from 4 to 20, and higher scores indicating greater perceived feasibility.
|
Immediately after review of training modules during the pre-trial prototype evaluation phase (approximately 4 months after study start)
|
|
Usability of Training Modules (Telehealth Usability Questionnaire - Usability Subscale [TUQ-US])
Time Frame: Immediately after review of training modules during the pre-trial prototype evaluation phase (approximately 4 months after study start)
|
The Usability Subscale of the Telehealth Usability Questionnaire (TUQ-US) assesses usability of the training modules.
The subscale includes items rated on a 1 to 7 scale, with higher scores indicating greater perceived usability of the training modules.
|
Immediately after review of training modules during the pre-trial prototype evaluation phase (approximately 4 months after study start)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ricardo Eiraldi, PhD, Children's Hospital of Philadelphia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-017895
- R18HS027755 (U.S. AHRQ Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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