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临床试验/NCT04654117
NCT04654117已完成不适用

Examining the Active Ingredients of Consultation to Improve Implementation of a Parent-mediated Intervention for Children With Autism in the Community Mental Health System

Michigan State University2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
2
主要终点
Case Penetration

研究概览

简要总结

Parent-mediated interventions are considered best practice for treating children with autism spectrum disorder, but these interventions are underutilized in community settings. Implementation strategies like consultation can improve the implementation of these interventions, but little is known about the active ingredients of consultation. This study uses an experimental design (ABCD single-case design with multiple baselines) to identify the active ingredients of a consultation model designed to support the implementation of a parent-mediated intervention for autism spectrum disorder in a low-resourced community mental health system.

详细描述

There are multiple evidence-based practices (EBPs) to treat autism spectrum disorder (ASD), yet the gap from when EBPs are developed to when they reach community settings is 17 years. EBPs are consistently underused in community settings despite their well-studied effectiveness. One such EBP for treating ASD in young children is parent-mediated intervention.

Consultation is one method of supporting implementation that involves providing clinicians with support and feedback from intervention experts. For this study, consultation on an evidence-based parent-mediated intervention, Project ImPACT, will be the focus. Understanding the active ingredients that go into consultation is important to understand how consultation works so that it can be tailored to best meet the needs of community settings. This single-case experimental design (SCED) will manipulate three potential ingredients of consultation: feedback on taped sessions, case support, and skill rehearsal.

Groups of 3-5 providers per agency will be given 2 weeks to complete a 6-hour self-directed online tutorial on Project ImPACT utilized regularly by Project ImPACT consultants. Next, each agency will be randomly assigned to baselines lasting 3-6 weeks, followed by 4 weeks of each consultation component (total of 12 weeks). All agencies will receive consultation. The order of the consultation components will be randomized using a random number generator such that each agency has an equal chance of receiving one of the predetermined permutations of phases which are labeled in alphabetical order (e.g., equally as likely to be randomized to ABCD order as ADBC order). Across each phase, providers will record one session per week with their enrolled family and submit it via a HIPAA-compliant Drop-box link. Providers will complete weekly online questionnaires on implementation outcomes, with time reserved during consultation sessions to complete them. After consultation, providers will submit a final recorded session and questionnaire 8-weeks post-consultation. Caregivers will complete a measure of social communication for their child via online questionnaire at baseline, twice during consultation, and after 8 weeks post-consultation.

The feedback phase will involve the consultant and peers responding to the 5-minute clips of recorded telehealth sessions with praise and constructive feedback. The case support phase will be a time for the consultant and peers to assist in any challenges faced; for example, this could include issues with telehealth, caregiver coaching, or family/child needs. The skill rehearsal phase will allow for consultees to practice their clinical skills via role play.

This study will have 4 aims:

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Case Penetration

时间窗: 23-26 weeks

Case penetration will be measured weekly using the Penetrability Formula and will be expressed using provider report of the total number of Project ImPACT cases on their caseload divided by the total number of eligible clients with ASD on their Medicaid Autism Benefit caseload. This is expressed as a percentage. Higher percentage values indicate higher case penetration.

Treatment Adherence

时间窗: 23-26 weeks

The Project ImPACT Coaching Fidelity Checklist is a measure of treatment adherence. It uses a 3-point scale -- Observed (1), Partially Observed (.5), and Not Observed (0). Higher scores indicate higher treatment adherence. Based on scoring guidelines for this measure, scores for each item are multiplied by an item-specific weight value. Scores for each item are then summed and divided by the total number of items scored, yielding a score ranging from 0 to 100.

Parent-mediated Intervention Competence

时间窗: 23-26 weeks

Parent-mediated intervention competence will be assessed via Parent Empowerment and Coaching in Early Intervention (PEACE) coding which utilizes a 5-point scale to assess for competency in delivering collaborative coaching techniques used in parent-mediated interventions. The scale used is: Never (1), Rarely (2), Sometimes (3), Often (4), and Almost Always (5). The minimum value on the scale is 1 and the maximum is 5. Higher scores indicate higher parent-mediated intervention competence.

Ratings of the Usability of Each Consultation Component

时间窗: 23-26 weeks

Clinicians reported on the usability of each consultation component weekly across the 4 weeks of each consultation condition using the Implementation Strategy Usability Scale (Lyon et al., 2021). This 10-item questionnaire uses a 5-point Likert scale to examine clinician perceptions about the complexity of using an implementation strategy. The scale is unidimensional and has no subscales. Based on scoring guidelines, a formula is used to calculate the total usability score, which ranges from 0-100. Higher scores indicate higher usability; higher scores indicate higher ratings of the participant's ability to use the strategy with ease. The formula involves the following: for each odd numbered item, subtract 1 from the Likert rating value to get the new value; for each even numbered item, subtract the Likert rating value from 5 to get a new value; then sum all new values and multiply by 2.5.

Ratings of Perceptions of Project ImPACT

时间窗: 23-26 weeks

Providers completed the Perceived Characteristics of Intervention Scale (PCIS; Cook et al., 2015) weekly about their perceptions of Project ImPACT. This 18-item questionnaire includes items related to various constructs from Rogers' Diffusions of Innovation theory (Rogers, 2010). All items are rated on a 7-point Likert scale and the overall PCIS score is established by computing the mean of all items. The minimum score is 1.00 and maximum is 7.00. Higher values indicate more positive perceptions of the intervention.

Child Social Communication Skills

时间窗: 23-26 weeks

The Autism Impact Measure has 41 items rated on a 5-point scale ranging from Never (1) to Always (5). The overall score is calculated by summing the scores on two scales (frequency and impact). Higher values indicate a higher frequency and impact of autism-related concerns child functioning. The minimum value is 82 and the maximum value is 410.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brooke Ingersoll

Professor of Psychology

Michigan State University

研究点 (2)

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