Improving the Part C Early Intervention Service Delivery System for Children With ASD

NCT05114538 | Active Not Recruiting DMC

• 2 other identifiers: STUDY000098351R01MH122727-01
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 4

Brief Summary

Despite strong consensus that early, specialized intervention for children with autism spectrum disorder (ASD) can have a dramatic impact on outcomes, the public health system's capacity to provide such services is severely challenged by the rapid rise in ASD prevalence. The goal of this research project is to increase timely and equitable access to ASD-specialized early intervention during the critical first three years of life by capitalizing on the existing infrastructure of the Part C Early Intervention (EI) system, which is publicly funded and available in all states in the United States. This project will train EI providers to use an evidence-based, parent-mediated intervention that can improve child and family outcomes as well as mitigate the long-term substantial economic costs associated with ASD.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Unstructured Imitation

  An adapted version of the UIA coding protocol (Ingersoll, 2012) will be used to measure spontaneous motor imitation within a virtual administration of an adapted version of the Communication Play Protocol (CPP; Adamson et al., 2004, Tagavi et al., 2025).

  Change from baseline to 4 months

Secondary Outcomes (12)

• Parenting Efficacy Scale (PES)

  Change from baseline to 9 months

• MacArthur Bates Communicative Development Inventory (MCDI)

  Change from baseline to 9 months

• CI-RIT Caregiver Fidelity Form

  Change from baseline to 4 months

• The Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO)

  Change from baseline to 4 months

• Weighted Frequency of Intentional Communication

  Change from baseline to 9 months

Other Outcomes (3)

• Parenting Stress Index-Short Form

  Baseline

• Developmental Play Assessment (DPA

  Baseline

• Vineland-3

  Baseline

Study Arms (2)

RIT Training Group

EXPERIMENTAL

Providers in the RIT group (n=80) will receive intensive training (online tutorial, 2-day workshop, and virtual coaching and feedback in the field) in RIT and parent coaching and will be required to achieve fidelity prior to enrolling families from their caseload. They will then be asked to use the intervention with enrolled families for a minimum of 3 months. One intervention session per month for each enrolled family will be videotaped and scored for fidelity. Providers will receive monthly consultation from RIT trainers while these families are in the active treatment phase.

Behavioral: Reciprocal Imitation Training

Treatment as Usual

NO INTERVENTION

Providers in the TAU group (n=80) will have three sessions videotaped and scored for each enrolled family to assess treatment differentiation. To incentivize agency participation, RIT training will be provided to the TAU group and other providers when data collection is complete.

Interventions

Reciprocal Imitation Training BEHAVIORAL

RIT is a relatively straightforward, brief NDBI. It employs four simple strategies to target motor imitation and IJA during play: (1) contingent imitation of the child's verbal and nonverbal behavior, (2) linguistic mapping, (3) direct elicitation of object and gesture imitation following the child's interest, and (4) contingent reinforcement. It has been used at low intensities (e.g., 1-3 hours per week) over short periods of time (e.g., 10-12 weeks) to produce robust changes in pivotal skills. It is easy to learn and can be implemented with fidelity by undergraduate-level therapists with limited backgrounds in ASD, as well as by parents and siblings.

RIT Training Group

Eligibility Criteria

• Age: 16 Months - 33 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child has a diagnosis of ASD or displays early social communication challenges
• Child receives ≥ 1 weekly session with the participating provider (not co-treated with another provider)
• Caregiver is present during EI sessions
• Caregiver is the biological parent or custodial guardian
• Caregiver is at least 18 years of age
• Caregiver speaks either English or Spanish

You may not qualify if:

• \- the child has visual, hearing, or motor conditions that would compromise his/her ability to participate in RIT or assessments

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator
• Michigan State University: collaborator
• University of Massachusetts, Boston: collaborator
• Rush University Medical Center: collaborator

Study Sites (4)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Massachusetts Boston

Boston, Massachusetts, 02125, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Carol A Schubert

Seattle, Washington, 98195, United States

Location

Related Publications (4)

• Nadwodny N, Yoder PJ, Ingersoll BR, Wainer AL, Stone WL, Eisenhower A, Carter AS; RISE Research Network. The Language ENvironment Analysis (LENA) System in Toddlers With Early Indicators of Autism: Test-Retest Reliability and Convergent Validity With Clinical Language Assessments. Autism Res. 2025 Aug;18(8):1568-1579. doi: 10.1002/aur.70062. Epub 2025 Jun 2.

  PMID: 40452405 DERIVED

• Wainer AL, Edmunds SR, Carter AS, Stone WL, Sheldrick RC, Broder-Fingert S, Stern YS, Harrington E, V Ibanez L, Ingersoll B. A hybrid type I randomized effectiveness-implementation trial of a Naturalistic Developmental Behavioral Intervention in the Part C early intervention system: study protocol. BMC Pediatr. 2025 Apr 1;25(1):263. doi: 10.1186/s12887-025-05587-8.

  PMID: 40170032 DERIVED

• Ingersoll B, Howard M, Oosting D, Carter AS, Stone WL, Berger N, Wainer AL, Britsch ER; RISE Research Network. Adapting measures of motor imitation for use by caregivers in virtual contexts: Reliability, validity, and sensitivity to change. Autism Res. 2025 Jan;18(1):122-132. doi: 10.1002/aur.3267. Epub 2024 Nov 21.

  PMID: 39569704 DERIVED

• Ingersoll B, Espinel A, Nauman J, Broder-Fingert S, Carter AS, Sheldrick RC, Stone WL, Wainer AL. Using virtual multiteam systems to conduct a multisite randomized clinical trial in the part C early intervention system: Benefits, challenges, and lessons learned. Contemp Clin Trials. 2024 Aug;143:107585. doi: 10.1016/j.cct.2024.107585. Epub 2024 May 29.

  PMID: 38821261 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Wendy L Stone, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Enrollment: 440 parent-child dyads; 160 providers (anticipated)

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: November 10, 2021
• Study Start: September 27, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)