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

• ClinicalTrials.gov Identifier: NCT05114538
• Recruitment Status: Recruiting
• First Posted: November 10, 2021
• Last Update Posted: January 31, 2023
• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH); Michigan State University; Rush University Medical Center; University of Massachusetts, Boston
• Information provided by (Responsible Party): Wendy Stone, University of Washington

Study Description

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 U.S. States. This project will train EI providers to use an evidence-based, inexpensive, parent-mediated intervention that can improve child and family outcomes as well as mitigate the long-term substantial economic costs associated with ASD.

Condition or disease	Intervention/treatment	Phase
Autism Spectrum Disorder	Behavioral: Reciprocal Imitation Training	Not Applicable

Detailed Description:

The long-term goal of this study is to improve services and outcomes for children with early signs of ASD by increasing the capacity to provide appropriately specialized treatment within an existing infrastructure: the Part C Early Intervention (EI) service delivery system. Part C is publicly funded, available throughout the United States, and serves children under age 3 who have developmental delays or disabilities. Currently, the effectiveness of EI services is limited by high practice variation and infrequent use of evidence-based interventions. We are conducting a randomized controlled trial (RCT) to examine the effectiveness of training EI providers to deliver Reciprocal Imitation Training (RIT) to children showing early signs of ASD. RIT is a naturalistic developmental behavioral intervention (NDBI) that is ideally suited for EI settings because it is low intensity, play-based, easy to learn and implement, and can be taught to families for their independent use, thus increasing intervention dosage. This RCT will employ a hybrid type 1 effectiveness/ implementation design and will use a unique mixed methods approach to gather evidence that will be essential for implementing RIT at scale, pending positive trial results. The sample includes 20 EI agencies across 4 U.S. States and comprises a total of 160 EI providers and 440 families of children with early symptoms of ASD, which not only provides a robust sample size, but also affords the opportunity to assess the generalizability of this approach across regions that vary in their implementation of Part C services. EI providers will be randomly assigned to the RIT training group (n=80) or treatment as usual (TAU; n=80). Providers in both groups will identify 2-5 children in their caseload who are 16-30 months old with early symptoms of ASD (n=220 children per group). Intensive, state-of-the art, multimethod assessment technology will be used to measure the impact of the intervention. Child and family assessments will be conducted at baseline, 4 months after enrollment, and 9 months after enrollment. Importantly, this study will examine putative mechanisms through which RIT improves clinically-relevant outcomes. In sum, this study will generate the evidence necessary to implement RIT at scale, thereby increasing the capacity of the existing EI system to deliver effective, evidence-based intervention to the rapidly growing population of children who show early signs of ASD.

Hypotheses:

1. Compared to TAU, children assigned to the RIT group will show more growth from baseline (T1) to the 9-month follow-up (T3) on language and social communication.
2. The impact of RIT on children's social communication and language outcomes at T3 will be mediated by gains in: (a) child joint attention; (b) child motor imitation; (c) parent contingent responsivity, and (d) caregiver fidelity of RIT strategies from baseline (T1) to the 4-month follow-up (T2).
3. Compared to TAU, caregivers assigned to the RIT group will show more improvement in parenting efficacy and family quality of life from baseline (T1) to the 9-month follow-up (T3).
4. The impact of RIT on parenting efficacy and family quality of life at T3 will be mediated by gains in parent contingent responsivity from baseline (T1) to the 4-month follow-up (T2).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 440 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Enrollement: 440 parent-child dyads; 160 providers (anticipated)
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Improving the Part C Early Intervention Service Delivery System for Children With ASD: A Randomized Clinical Trial
• Actual Study Start Date: September 27, 2021
• Estimated Primary Completion Date: May 31, 2025
• Estimated Study Completion Date: May 31, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: RIT Training Group; 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; 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.
No Intervention: Treatment as Usual; 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.

Outcome Measures

Primary Outcome Measures :

1. Weighted Frequency of Intentional Communication [ Time Frame: Change from baseline to 9 months ]
   The Weighted Frequency of Intentional Communication coding protocol will be used to measure expressive communication during a virtual administration of an adapted version of the Communication Play Protocol (CPP; Adamson et al., 2004). [Hypothesis 1]
2. Vineland-3 [ Time Frame: Change from baseline to 9 months ]
   The Communication and Social Domain standard scores from the Vineland-3 will be used to measure child social communication [Hypothesis 1]
3. Parenting Efficacy Scale (PES) [ Time Frame: Change from baseline to 9 months ]
   The PES Total Score will be used to measure parenting efficacy. [Hypothesis 3]
4. Initiation of Joint Attention [ Time Frame: Change from baseline to 4 months ]
   An adapted version of the ESCS coding protocol (Roos et al., 2008) will be used to measure initiation of joint attention within a virtual administration of an adapted version of the Communication Play Protocol (CPP; Adamson et al., 2004). [Hypotheses 2; Putative Mechanism/Mediator]
5. Unstructured Imitation [ Time Frame: Change from baseline to 4 months ]
   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). [Hypotheses 2; Putative Mechanism/Mediator]
6. Adapted Motor Imitation Scale (MIS) [ Time Frame: Change from baseline to 4 months ]
   Elicited motor imitation will be assessed using a virtually-administered version of the Motor Imitation Scale (MIS). [Hypotheses 2; Putative Mechanism/Mediator]
7. The Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO) [ Time Frame: Change from baseline to 4 months ]
   The PICOOLO coding protocol will be used to measure parent responsivity from parent child interaction videos. [Hypotheses 2 & 4; Putative Mechanism/Mediator]
8. RIT Fidelity Form (RIT-FF) [ Time Frame: Change from baseline to 4 months ]
   The RIT-FF will be used to measure parent fidelity of the RIT strategies from parent child interaction videos. [Hypothesis 2; Putative Mechanism/Mediator]

Secondary Outcome Measures :

1. MacArthur Bates Communicative Development Inventory (MCDI) [ Time Frame: Change from baseline to 9 months ]
   The total number of words said on the MCDI will be used to measure expressive vocabulary. [Hypothesis 1]
2. Language Environment Analysis (LENA) Vocal Complexity [ Time Frame: Change from baseline to 9 months ]
   Child vocal complexity will be based on recorded language using LENA Software. [Hypothesis 1]
3. Language Environment Analysis (LENA) Vocal Contingency [ Time Frame: Change from baseline to 9 months ]
   Child reciprocal vocal contingency will be based on recorded language using the LENA software. [Hypothesis 1]
4. Parent Interview for Autism-Clinical Version (PIA-CV) [ Time Frame: Change from baseline to 9 months ]
   Social Communication domains from the PIA-CV will be used to measure child social communication. [Hypothesis 1]
5. Family Life Impairment Scale (FLIS) [ Time Frame: Change from baseline to 9 months ]
   The FLIS Total Impairment Score will be used to measure family well-being. [Hypothesis 3]

Other Outcome Measures:

1. Parenting Stress Index-Short Form [ Time Frame: Baseline ]
   Parenting stress will be measured using the Parenting Stress Index-Short Form (PSI-SF) [Moderator]
2. Developmental Play Assessment (DPA [ Time Frame: Baseline ]
   Total number of differentiated acts on toys will be assessed using a virtually-administered version of the Developmental Play Assessment (DPA) [Moderator]
3. Vineland-3 [ Time Frame: Baseline ]
   The Adaptive Behavior Composite score will be used to measure child developmental level [Moderator]

Eligibility Criteria

• Ages Eligible for Study: 16 Months to 30 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• parents are biological parents or custodial guardians
• parents are at least 18 years of age
• parents speak either English or Spanish
• the child has a diagnosis of ASD or displays social communication impairments
• The child attends at minimum 1x/week sessions with the enrolled provider

Exclusion Criteria

• the parent or child has previously received RIT or coaching in another NDBI
• the child has visual, hearing, or motor conditions that would compromise his/her ability to participate in RIT or assessments

Contacts and Locations

Contacts

Contact: Carol A Schubert, MPH; 206-543-2823; schubca@uw.edu

Contact: Wendy K Stone, PhD; 206-685-2821; stonew@uw.edu

Locations

United States, Illinois

Rush University Medical Center; Recruiting

Chicago, Illinois, United States, 60612

Contact: Anna Hirshman, BA Anna_Hirshman@rush.edu

Principal Investigator: Allison Wainer, PhD

United States, Massachusetts

University of Massachusetts Boston; Recruiting

Boston, Massachusetts, United States, 02125

Contact: Alice Carter, PhD AliceS.Carter@umb.edu

Principal Investigator: Alice Carter, PhD

United States, Michigan

Michigan State University; Recruiting

East Lansing, Michigan, United States, 48824

Contact: Julia Nauman, BS naumanj@msu.edu

Principal Investigator: Brooke Ingersoll, PhD

United States, Washington

Carol A Schubert; Recruiting

Seattle, Washington, United States, 98195

Contact: Carol A Schubert, MPH 206-543-2823 schubca@uw.edu

Principal Investigator: Wendy Stone, PhD

Sponsors and Collaborators

University of Washington

National Institute of Mental Health (NIMH)

Michigan State University

Rush University Medical Center

University of Massachusetts, Boston

Investigators

• Principal Investigator: Wendy L Stone, PhD; University of Washington

More Information

• Responsible Party: Wendy Stone, Professor, Psychology, University of Washington
• ClinicalTrials.gov Identifier: NCT05114538
• Other Study ID Numbers: STUDY00009835; 1R01MH122727-01 ( U.S. NIH Grant/Contract )
• First Posted: November 10, 2021
• Last Update Posted: January 31, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders