Clinical trial NCT04654117: Examining the Active Ingredients of Consultation of a Parent-mediated Intervention for Autism
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Consultation
Autism Spectrum Disorder
Medicaid
Parent-mediated intervention
Parent Training
Lead sponsor: Michigan State University
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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 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:

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.

Eligibility criteria: Groups of 3-5 providers will be recruited from four applied behavior analysis (ABA) agencies (\~20 providers in total) that contract with regional community mental health agencies to provide ABA services to Medicaid-enrolled children with autism spectrum disorder (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

Primary outcomes:
measure: Treatment Adherence
timeFrame: 23-26 weeks
measure: Parent-mediated Intervention Competence
timeFrame: 23-26 weeks
measure: Case Penetration
timeFrame: 23-26 weeks
measure: Ratings of the Usability of Each Consultation Component
timeFrame: 23-26 weeks
measure: Ratings of Perceptions of Project ImPACT
timeFrame: 23-26 weeks
measure: Child Social Communication Skills
timeFrame: 23-26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
Study officials:
affiliation: Michigan State University
name: Brooke Ingersoll
role: PRINCIPAL_INVESTIGATOR
References: