Examining the Active Ingredients of Consultation of a Parent-mediated Intervention for Autism

NCT04654117 | Completed Results

• 1 other identifier: R40MC27705
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder

Keywords

Consultation; Autism Spectrum Disorder; Medicaid; Parent-mediated intervention; Parent Training

Outcome Measures

Primary Outcomes (6)

• Treatment Adherence

  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.

  23-26 weeks

• 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 1 and the maximum is 5. Higher scores indicate higher parent-mediated intervention competence.

  23-26 weeks

• 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

• Ratings of the Usability of Each Consultation Component

  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.

  23-26 weeks

• Ratings of Perceptions of Project ImPACT

  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.

  23-26 weeks

• Child Social Communication Skills

  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.

  23-26 weeks

Study Arms (3)

Baseline

NO INTERVENTION

Following completing the online tutorial, each agency will have a baseline lasting 3-6 weeks (this will be staggered by agency).

Treatment (Consultation)

EXPERIMENTAL

Consultation will be conducted in 4-week phases that correspond to the three consultation components. The phases will occur in a randomized order. During a given phase, no components of any other phases will be provided. Feedback phase. Consultees will submit 5-minute clips of session recordings of their Project ImPACT session with their enrolled family for feedback. Oral feedback will be provided by the consultant and peers. Case support phase. The consultant will lead the group in problem-solving common barriers that providers experience with their cases. Skill rehearsal phase. The consultant will lead skill rehearsal practices in which providers role play elements of a Project ImPACT session.

Other: Consultee-centered administrative consultation

Follow Up

NO INTERVENTION

During the follow-up period, consultation will not occur, and providers will continue implementing Project ImPACT with their cases. Eight weeks post-consultation, providers will submit a recorded Project ImPACT session with their enrolled family. Providers and caregivers will complete a final online questionnaire.

Interventions

Consultee-centered administrative consultation OTHER

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

Treatment (Consultation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Not qualified to bill for ABA services through the Medicaid Autism Benefit.
• Under age 18
• 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.
• Under age 18

Sponsors & Collaborators

• Michigan State University: lead

Study Sites (1)

Michigan State University

East Lansing, Michigan, 48824, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Brooke Ingersoll, Professor
• Organization: Department of Psychology, Michigan State University

ingers19@msu.edu

517-432-8412

Study Officials

• Brooke Ingersoll

  Michigan State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: November 29, 2020
• First Posted: December 4, 2020
• Study Start: October 1, 2021
• Primary Completion: October 14, 2022
• Study Completion: March 30, 2023
• Last Updated: April 3, 2025
• Results First Posted: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)