Clinical trial NCT05114538: Improving the Part C Early Intervention Service Delivery System for Children with ASD
Official title: Improving the Part C Early Intervention Service Delivery System for Children with ASD: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Michigan State University
name: Rush University Medical Center
name: University of Massachusetts, Boston
First posted: 2021-11-10
Enrollment: 440
Sex: ALL
Minimum age (years): 16
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Enrollment: 440 parent-child dyads; 160 providers (anticipated)
Primary purpose: TREATMENT

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.

Detailed description: The long-term goal of this study is to improve services and outcomes for children with early social communication challenges and/or 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 Caregiver-Implemented Reciprocal Imitation Teaching (CI-RIT) to children showing early social communication challenges. 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 (in the form of CI-RIT), 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 a target of 20 EI agencies (across 4 U.S. States), 160 EI providers and 440 families of children with early social communication challenges, 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 16-33 months old with early social communication delays (target 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 social communication challenges.

The objectives of the RISE study are as follows:

1. To test the effectiveness of CI-RIT as delivered by community-based EI providers for improving child- and caregiver/family-level outcomes. We hypothesize that compared to TAU, children working with CI-RIT providers will demonstrate greater improvements in motor imitation and joint attention at T2 (4-months post-baseline), and language and social communication at T3 (9-months post-baseline). We also hypothesize that compared to TAU, caregivers working with CI-RIT providers will show greater improvements in contingent responsivity, RIT strategy use, parenting efficacy, and family quality of life.
2. To analyze the mechanisms by which CI-RIT improves outcomes. We hypothesize that changes in children's social communication and language outcomes will be serially mediated by gains in: (a) caregiver contingent responsivity and caregiver RIT strategy use, and (b) children's motor imitation and joint attention. We hypothesize that changes in caregiver/family outcomes will be mediated by gains in caregiver contingent responsivity, caregiver RIT strategy use, child motor imitation, and child joint attention.
3. To prepare for implementation at scale by identifying potential sources of practice variation to inform refinement of RIT training and development of quality assurance protocols. Triangulating evidence from video observations of EI sessions, EI provider self-reports, and qualitative interviews, we will use the Model for Adaptation Design (MADI) framework (32) to characterize the modifications to RIT that providers make (MADI domain 1), to identify potential mediating or moderating factors of these modifications (e.g., relationship to fidelity, rationale) (MADI domain 2), and to explore whether all or certain modifications influence implementation outcomes (e.g., ongoing fidelity, treatment acceptability) (MADI domain 3). This robust implementation evaluation will provide relevant information for improving the delivery of all NDBIs in the Part C system.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria

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

Primary outcomes:
measure: Weighted Frequency of Intentional Communication
timeFrame: Change from baseline to 9 months
measure: Vineland-3
timeFrame: Change from baseline to 9 months
measure: Parenting Efficacy Scale (PES)
timeFrame: Change from baseline to 9 months
measure: Initiation of Joint Attention
timeFrame: Change from baseline to 4 months
measure: Unstructured Imitation
timeFrame: Change from baseline to 4 months
measure: Adapted Motor Imitation Scale (MIS)
timeFrame: Change from baseline to 4 months
measure: The Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO)
timeFrame: Change from baseline to 4 months
measure: CI-RIT Caregiver Fidelity Form
timeFrame: Change from baseline to 4 months
Secondary outcomes:
measure: MacArthur Bates Communicative Development Inventory (MCDI)
timeFrame: Change from baseline to 9 months
measure: Language Environment Analysis (LENA) Vocal Complexity
timeFrame: Change from baseline to 9 months
measure: Language Environment Analysis (LENA) Vocal Contingency
timeFrame: Change from baseline to 9 months
measure: Parent Interview for Autism-Clinical Version (PIA-CV)
timeFrame: Change from baseline to 9 months
measure: Family Life Impairment Scale (FLIS)
timeFrame: Change from baseline to 9 months
Other outcomes:
measure: Parenting Stress Index-Short Form
timeFrame: Baseline
measure: Developmental Play Assessment (DPA
timeFrame: Baseline
measure: Vineland-3
timeFrame: Baseline
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Boston
country: United States
facility: University of Massachusetts Boston
state: Massachusetts
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Seattle
country: United States
facility: Carol A Schubert
state: Washington
Study officials:
affiliation: University of Washington
name: Wendy L Stone, PhD
role: PRINCIPAL_INVESTIGATOR
References: