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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04654117
• Other study ID #: R40MC27705
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: March 30, 2023

Study information

• Verified date: October 2023
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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 (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:

Specific Aim 1: Identify the potential active ingredients of the consultation model by evaluating its effects on providers' treatment adherence and parent-mediated intervention competence. The investigators predict that the feedback component will improve adherence and competence over and above improvements from the case support and skill rehearsal components.

Specific Aim 2: Examine the relative feasibility, acceptability, and appropriateness of each consultation component using a SCED component analysis. Feasibility is the extent to which a practice can be successfully carried out within a setting. Acceptability is the extent to which a practice is agreeable and satisfactory. Appropriateness is the perceived fit or relevance of a practice to address a problem. The investigators predict that providers will perceive the case support component to be the most feasible, acceptable, and appropriate of all components.

Specific Aim 3: Examine the effects of the consultation model on case penetration and the feasibility, acceptability, and appropriateness of the EBP (Project ImPACT). The investigators predict case penetration (i.e., total number of Project ImPACT cases on a provider's caseload divided by the total number of eligible clients) and EBP feasibility, acceptability, and appropriateness to increase over time.

Exploratory Aim 4: Demonstrate associated social communication outcomes for Medicaid-enrolled children with ASD from baseline to post-consultation. Given that consultation leads to improved adherence and child outcomes and Project ImPACT results in improved child social communication outcomes, the investigators predict that our consultation model will be associated with improvements in child social communication skills.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 30, 2023
• Est. primary completion date: October 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Groups of 3-5 providers will be recruited from four ABA agencies (~20 providers in total) that contract with regional community mental health agencies to provide ABA services to Medicaid-enrolled children with ASD. Families on the providers' caseloads will be enrolled.

Inclusion Criteria for Providers:

• Have at least one caregiver on their caseload who would be appropriate for Project ImPACT and who agrees to enroll in the study and have their sessions recorded.

Exclusion Criteria for Providers:

• Not qualified to bill for ABA services through the Medicaid Autism Benefit.

• Under age 18

Inclusion Criteria for Caregivers:

• Parent or guardian of a child who has a community diagnosis of ASD established using the Autism Diagnostic Observation Schedule (a gold standard ASD assessment), receives services through the Medicaid Autism Benefit (requires a household income at or below 133% of the federal poverty line), is between the ages of 18 months and 6 years, which is the age range targeted for Project ImPACT, and has at least 1 session per week with the provider.

• Child's provider is enrolled in the study.

Exclusion Criteria for Caregivers:

• Under age 18

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Other:
• Consultee-centered administrative consultation
The consultee-centered administrative consultation model expressly focuses on supporting providers to increase EBP implementation within their specific setting.

Locations

Country	Name	City	State
United States	Michigan State University	East Lansing	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Michigan State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment adherence	The Project ImPACT Coaching Fidelity Checklist will be employed to measure treatment adherence. It uses a 3-point scale -- Observed (1), Partially Observed (.5), and Not Observed (0). The minimum value on the scale is 0 and the maximum value is 13. Higher scores indicate higher treatment adherence.	23-26 weeks
Primary	Parent-mediated intervention competence	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 25 and the maximum value is 125. Higher scores indicate higher parent-mediated intervention competence.	23-26 weeks
Primary	Case penetration	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.	23-26 weeks
Primary	Ratings of feasibility, acceptability, and appropriateness of each consultation phase	Providers will give ratings Intervention Strategy Usability Scale to characterize provider perceptions of the feasibility, acceptability, and appropriateness of consultation strategies. The scale used is: Strongly disagree (1), Disagree (2), Neither disagree or agree (3), Agree (4), and Strongly agree (5). Higher scores indicate higher feasibility, acceptability, and appropriateness of each phase.	23-26 weeks
Primary	Ratings of feasibility, acceptability, and appropriateness of Project ImPACT	Providers will give ratings on the Perceived Characteristics of Intervention Scale to characterize provider perceptions of the feasibility, acceptability, and appropriateness of Project ImPACT. The scale used is: Strongly disagree (1), Disagree (2), Neither disagree or agree (3), Agree (4), and Strongly agree (5). Higher scores indicate higher feasibility, acceptability, and appropriateness of each phase. Higher scores indicate higher feasibility, acceptability, and appropriateness of Project ImPACT.	23-26 weeks
Primary	Child social communication skills	The Autism Impact Measure (AIM) will be used to measure child social communication at baseline, in week 6 and week 12 of the consultation phase, and 8 weeks into post-consultation. The AIM contains five empirically derived subdomain scores: Repetitive Behavior, Atypical Behavior, Communication, Social Reciprocity, and Peer Interaction. Forty-one items are rated based on a 5-point scale ranging from Never (1) to Always (5) for frequency and impact. The minimum value for each scale (frequency and impact) is 41 and the maximum value is 205. Higher values indicate higher frequency of concerns and higher impact of concerns on child functioning.	23-26 weeks