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临床试验/NCT05034198
NCT05034198已完成不适用

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

Children's Hospital of Philadelphia2 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2020年9月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
174
试验地点
2
主要终点
Content Fidelity of Cognitive Behavioral Therapy (CBT) for Anxiety Treatment in Schools (CATS) Implementation

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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-
  • 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-
  • 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.

研究组 & 干预措施

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.

干预措施: Coping Power Program (CPP) (Behavioral)

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.

干预措施: Cognitive behavioral therapy (CBT) for Anxiety Treatment in Schools (CATS) (Behavioral)

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.

干预措施: Check-in/Check-out (CI/CO) (Behavioral)

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.

干预措施: Check-in/Check-out (CI/CO) (Behavioral)

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.

干预措施: Coping Power Program (CPP) (Behavioral)

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.

干预措施: Cognitive behavioral therapy (CBT) for Anxiety Treatment in Schools (CATS) (Behavioral)

Control Condition (T)

Active Comparator

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

干预措施: Coping Power Program (CPP) (Behavioral)

Control Condition (T)

Active Comparator

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

干预措施: Cognitive behavioral therapy (CBT) for Anxiety Treatment in Schools (CATS) (Behavioral)

Control Condition (T)

Active Comparator

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

干预措施: Check-in/Check-out (CI/CO) (Behavioral)

结局指标

主要结局

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

时间窗: 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.

Content Fidelity of Coping Power Program (CPP) Implementation

时间窗: 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.

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

时间窗: 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.

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

时间窗: 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.

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

时间窗: 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.

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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