Evidence map›Paper›PMID 40170032›Full record

ArticleBMC pediatrics2025

A hybrid type I randomized effectiveness-implementation trial of a Naturalistic Developmental Behavioral Intervention in the Part C early intervention system: study protocol.

Allison L Wainer, Sarah R Edmunds, Alice S Carter, Wendy L Stone, R Christopher Sheldrick, Sarabeth Broder-Fingert, Yael S Stern, Ellie Harrington, Lisa V Ibanez, Brooke Ingersoll

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC pediatrics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05114538 (Improving the Part C Early Intervention Service Delivery System for Children With ASD), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05114538 naactive not recruitingnot on this map

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

TypeinterventionalSponsorRush University Medical CenterRan2021 to 2027Enrolled440ConditionsAutism Spectrum DisorderArmsReciprocal Imitation Training
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Allison L WainerDepartment of Psychiatry and Behavioral Sciences, Rush University Medical Center, 1645 W. Jackson Blvd., Suite 603, Chicago, IL, 60612, USA. allison_wainer@rush.edu.
Sarah R EdmundsDepartment of Psychology, University of South Carolina, Barnwell College, 1512 Pendleton St, Columbia, SC, 29208, USA.
Alice S CarterDepartment of Psychology, University of Massachusetts Boston, 100 Morrissey Boulevard, Boston, MA, 02125, USA.
Wendy L StoneDepartment of Psychology, University of Washington, Guthrie Hall Box 351525, Seattle, WA, 98195, USA.
R Christopher SheldrickDepartment of Psychiatry, UMass Chan Medical School, 55 Lake Avenue North, Worcester, MA, 01655, USA.
Sarabeth Broder-FingertDepartment of Pediatrics, UMass Chan Medical School, 55 Lake Avenue North, Worcester, MA, 01655, USA.
Yael S SternANNA Autism Care, 490 Boston Post Road, Sudbury, MA, 01776, USA.
Ellie HarringtonANNA Autism Care, 490 Boston Post Road, Sudbury, MA, 01776, USA.
Lisa V IbanezDepartment of Psychology, University of Washington, Guthrie Hall Box 351525, Seattle, WA, 98195, USA.
Brooke IngersollDepartment of Psychology, Michigan State University, 316 Physics Rd., Room 105B, East Lansing, MI, 48824, USA.

Funding

3/4: Improving the Part C Early Intervention Service Delivery System for Children with ASD: A Randomized Clinical TrialR01MH122726 · NIMH · RUSH UNIVERSITY MEDICAL CENTER · PI WAINER, ALLISON LEIGH · 2020 to 2024
$3.3M
NIMH NIH HHS R01 MH122726
6 · The paper itself

Abstract

backgroundParticipation in Naturalistic Developmental Behavioral Interventions (NDBI) is associated with significant improvements in functioning for toddlers with, and showing early signs of, autism spectrum disorder. The Part C Early Intervention (EI) system, which is publicly funded and available in all U.S. states, offers an optimal infrastructure through which toddlers can receive NDBIs. This study seeks to assess the effectiveness and fit of one NDBI, Caregiver Implemented Reciprocal Imitation Teaching (CI-RIT), within the Part C EI system.

methodsThis hybrid type 1 effectiveness/implementation trial uses a multi-site randomized control design to simultaneously test effectiveness and collect implementation data on CI-RIT in the Part C EI system across four states: Illinois, Massachusetts, Michigan and Washington. Participants include EI providers (target n = 160) who are randomized to either CI-RIT or treatment as usual (TAU), and child/caregiver dyads on their caseloads (target n = 440). Primary effectiveness outcomes focus on (1) child social communication, joint attention, motor imitation; and (2) caregiver responsivity, implementation fidelity of RIT, and self-efficacy, which are all measured at baseline and then 4-months and 9-months after baseline. Implementation outcomes include CI-RIT modifications, treatment acceptability, fidelity of CI-RIT coaching, and RIT session completion. DISCUSSION: This study represents a critical effort to transport an evidence-based NDBI, CI-RIT, into a national service delivery setting, the Part C EI system. The large, multi-site nature of the trial provides the opportunity to address critical questions about training and intervention effectiveness, which will, in turn, optimize and support CI-RIT implementation at scale.

trial registrationThe trial protocol is registered at ClinicalTrials.gov (NCT05114538; Registration date: 10/28/2021).

Indexed as

Autism Spectrum DisorderBehavior TherapyEarly Intervention, EducationalCaregiversChild, PreschoolHumansInfantMulticenter Studies as TopicRandomized Controlled Trials as TopicAutism spectrum disorderNaturalistic Developmental Behavioral InterventionPart C Early InterventionReciprocal Imitation Teaching

Identifiers

PMID40170032
PMCPMC11959790

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.