Saturday, November 23, 2024 11/23/2024

4/4: Improving the Part C Early Intervention Service Delivery System for Children with ASD: A Randomized Clinical Trial

Award Number: R01MH122728
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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PROJECT SUMMARY Despite strong consensus that early, specialized intervention for children with Autism Spectrum Disorder (ASD) can have a dramatic impact on outcomes, the U.S. health system’s capacity to provide such services is severely challenged by the rapid rise in ASD prevalence. The long-term goal is to improve 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 in all areas, 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. The study objective is to improve services and outcomes for children with early signs of ASD by conducting a randomized controlled trial (RCT) testing the effectiveness of training EI providers to deliver Reciprocal Imitation Training (RIT). 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, multi- method 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. Importantly, this study will examine putative mechanisms (i.e., child gains in imitation and joint attention; parent contingent responsiveness) through which the intervention improves clinically-relevant outcomes. 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $978,711 )
2024	2024	UNIVERSITY OF MASS AT BOSTON	100 WILLIAM T MORRISSEY BLVD	DORCHESTER	MA	02125	SUFFOLK	USA	Mental Health Research Grants	001	5	6/5/2024	NON-COMPETING CONTINUATION	$860,660
2024	2024	UNIVERSITY OF MASS AT BOSTON	100 WILLIAM T MORRISSEY BLVD	DORCHESTER	MA	02125	SUFFOLK	USA	Mental Health Research Grants	002	5	6/12/2024	SUPPLEMENT FOR EXPANSION	$77,027
2024	2024	UNIVERSITY OF MASS AT BOSTON	100 WILLIAM T MORRISSEY BLVD	DORCHESTER	MA	02125	SUFFOLK	USA	Mental Health Research Grants	000	4	4/18/2024	SUPPLEMENT FOR EXPANSION	$41,024
														Subtotal = $978,711

Issue Date FY: 2023 ( Subtotal = $933,510 )
2023	2023	UNIVERSITY OF MASSACHUSETTS	100 MORRISSEY BLVD RM 80	BOSTON	MA	02125	SUFFOLK	USA	Mental Health Research Grants	000	4	5/30/2023	NON-COMPETING CONTINUATION	$933,510
														Subtotal = $933,510

Issue Date FY: 2022 ( Subtotal = $967,959 )
2022	2022	UNIVERSITY OF MASSACHUSETTS	100 MORRISSEY BLVD RM 80	BOSTON	MA	02125	SUFFOLK	USA	Mental Health Research Grants	001	3	6/16/2022	SUPPLEMENT FOR EXPANSION	$9,653
2022	2022	UNIVERSITY OF MASSACHUSETTS	100 MORRISSEY BLVD RM 80	BOSTON	MA	02125	SUFFOLK	USA	Mental Health Research Grants	000	3	6/15/2022	NON-COMPETING CONTINUATION	$958,306
														Subtotal = $967,959

Issue Date FY: 2021 ( Subtotal = $1,091,642 )
2021	2021	UNIVERSITY OF MASSACHUSETTS	100 MORRISSEY BLVD RM 80	BOSTON	MA	02125	SUFFOLK	USA	Mental Health Research Grants	001	1	1/13/2021	SUPPLEMENT FOR EXPANSION	-$44,024
2021	2021	UNIVERSITY OF MASSACHUSETTS	100 MORRISSEY BLVD RM 80	BOSTON	MA	02125	SUFFOLK	USA	Mental Health Research Grants	000	1	1/11/2021	SUPPLEMENT FOR EXPANSION	$44,024
2021	2021	UNIVERSITY OF MASSACHUSETTS	100 MORRISSEY BLVD RM 80	BOSTON	MA	02125	SUFFOLK	USA	Mental Health Research Grants	003	2	5/14/2021	NON-COMPETING CONTINUATION	$1,047,618
2021	2021	UNIVERSITY OF MASSACHUSETTS	100 MORRISSEY BLVD RM 80	BOSTON	MA	02125	SUFFOLK	USA	Mental Health Research Grants	002	1	1/29/2021	SUPPLEMENT FOR EXPANSION	$44,024
														Subtotal = $1,091,642

Issue Date FY: 2020 ( Subtotal = $982,512 )
2020	2020	UNIVERSITY OF MASSACHUSETTS	100 MORRISSEY BLVD RM 80	BOSTON	MA	02125	SUFFOLK	USA	Mental Health Research Grants	000	1	4/27/2020	NEW	$982,512
2020	2020	UNIVERSITY OF MASSACHUSETTS	100 MORRISSEY BLVD RM 80	BOSTON	MA	02125	SUFFOLK	USA	Mental Health Research Grants	001	1	5/14/2020	NEW	$0
														Subtotal = $982,512

Grand Total All Awards = $4,954,334

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4/4: Improving the Part C Early Intervention Service Delivery System for Children with ASD: A Randomized Clinical Trial

Award Number: R01MH122728

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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