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

Sponsor
University of Washington (Other)
Overall Status
Recruiting
CT.gov ID
NCT05114538
Collaborator
National Institute of Mental Health (NIMH) (NIH), Michigan State University (Other), Rush University Medical Center (Other), University of Massachusetts, Boston (Other)
440
4
2
17.1
110
6.4

Study Details

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
  • Behavioral: Reciprocal Imitation Training
N/A

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 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 on children's language and social communication, as well as parents' self-efficacy and well-being. Child and family assessments will be conducted at baseline, 3 months after enrollment, and 9 months after enrollment. Importantly, this study will examine putative mechanisms through which RIT improves clinically-relevant outcomes (i.e., child gains in imitation and joint attention; parent contingent responsiveness). Data regarding provider-initiated modifications to the intervention and delivery will be analyzed to identify fidelity-consistent vs. fidelity inconsistent changes, which will inform refinement of future RIT training and quality assurance procedures. 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.

  1. 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) in motor imitation, initiating joint attention, 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; and (c) parent contingent responsivity, as measured from baseline to the 3 month follow-up (T2).

  3. Compared to TAU, caregivers assigned to the RIT group will show more improvement in contingent responsivity, parenting efficacy, and family quality of life from baseline to the 9-month follow-up.

  4. The impact of RIT on growth of children's social communication and language outcomes from baseline to the 9-month follow-up will be mediated by: (a) providers' fidelity of use of RIT strategies following training; and (b) caregivers' frequency and fidelity of use of RIT strategies after treatment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
440 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Enrollement: 440 parent-child dyads; 160 providers (anticipated)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 :
Sep 27, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

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. Child Intentional Communication [Change from baseline to 6 months after entry]

    Children's expressive communication during play activities will be coded observationally using the Weighted Frequency of Intentional Communication coding protocol. The primary outcome will be the change in the weighted frequency of intentional communication from baseline to 6 months after entry.

  2. Child Initiation of Joint Attention (IJA) [Change from baseline to 3 months after entry]

    Two scenes from the Communication Play Protocol (CPP; Adamson et al., 2004) will be used to assess IJA and an adapted version of the ESCS coding protocol will be applied to these scenes (Roos et al., 2008). The primary outcome will be the change in child-initiated joint attention from baseline to 3 months after entry.

  3. Child Spontaneous Motor Imitation [Change from baseline to 3 months after entry]

    Change from baseline to 3 months after entry in spontaneous motor imitation will be assessed using a scene from the Communication Play Protocol (CPP; Adamson et al., 2004).

  4. Parent Contingent Responsivity [Change from baseline to 3 months after entry]

    Parent contingent responsivity will be assessed using the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO). The primary outcome will be change in parent contingent responsivity from baseline to 3 months after entry.

Secondary Outcome Measures

  1. Child Elicited Motor Imitation [Change from baseline to 3 months after entry]

    Change from baseline to 3 months after entry in motor imitation will be assessed using an adapted version of the Motor Imitation Scale (MIS) that will be administered virtually in the families' home.

  2. Child Social Communication [Change from baseline to 6 months after entry]

    Change from baseline to 6 months after entry in child language will be assessed using the MacArthur Bates Communicative Development Inventory (MCDI).

  3. Parenting Self-Efficacy [Change from baseline to 6 months after entry]

    Change from baseline to 6 months after entry in parenting self-efficacy will be measured using the Parenting Efficacy Scale (PES). Ten items reflecting perceived competence across several domains of childcare (e.g., understanding what the child wants) are rated on a 4-point Likert scale.

  4. Family Quality of Life [Change from baseline to 6 months after entry]

    Change from baseline to 6 months after entry in family well-being will be measured using the Family Life Impairment Scale (FLIS).

  5. Parenting Stress [Change from baseline to 6 months after entry]

    Change in parenting stress will be measured using the Parenting Stress Index-Short Form (PSI-SF).

  6. Child Total Word Count [Change from baseline to 6 months after entry]

    Change from baseline to 6 months after entry in child total word count will be based on recorded language using the LENA software.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Months to 30 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Rush University Medical Center Chicago Illinois United States 60612
2 University of Massachusetts Boston Boston Massachusetts United States 02125
3 Michigan State University East Lansing Michigan United States 48824
4 University of Washington Seattle Washington United States 98195

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wendy Stone, Professor, Psychology, University of Washington
ClinicalTrials.gov Identifier:
NCT05114538
Other Study ID Numbers:
  • STUDY00009835
  • 1R01MH122727-01
First Posted:
Nov 10, 2021
Last Update Posted:
Nov 22, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
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:

Study Results

No Results Posted as of Nov 22, 2021