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Twitter/X Essai clinique clinicaltrials.gov Extrait cité dans le billet Question posée par Dawson dans le billet Lien intégré au billet Termes sur l’autisme

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Essai clinique Récupéré Publication clinicaltrials.gov

Florida State University, National Institute of Mental Health (NIMH) (2023). Effectiveness Trial of Mobile ESI for Toddlers With Autism Identified by Early Screening in Primary Care. ClinicalTrials.gov. Florida State University.

Date de publication
15/03/2023
Identifiant
NCT05456139
Auteurs
Florida State University, National Institute of Mental Health (NIMH)
Source
ClinicalTrials.gov
Type de référence
clinical_trial
Éditeur
Florida State University
Source de métadonnées
clinicaltrials.gov

Résumé

The goal of this collaborative R01 is to demonstrate the therapeutic value and community-wide implementability of an early intervention (EI) platform for toddlers with autism spectrum disorder (ASD) that is completely virtual, from recruitment through intervention. This platform-Early Social Interaction Mobile Coaching (ESI-MC) deploys individual telehealth sessions with coaching and feedback to help families embed intervention in everyday activities. Specifically, the investigators will conduct an effectiveness trial of ESI-MC to address the important question of whether starting evidence-based intervention earlier leads to better outcomes than starting later. The investigators will address this question by using a modified stepped wedge design and blended implementation research to analyze data obtained with ESI-MC start at 18, 24, or 30 months. The investigators will diagnostically ascertain 240 children from a pool of 360 18-month-olds with early signs of autism, 30 in each of 8 US regions (Central and SW Florida; Atlanta, GA; suburbs of Philadelphia, PA; New York City, NY; Cincinnati, OH; Chicago, IL; Seattle, WA; and Los Angeles, CA). Research participants will be recruited using a new virtual platform-My Baby Navigator-linking a new surveillance and screening tool, an app to upload video-recorded home observations and telehealth intervention sessions, and a package of educational resources. The 240 children will be randomly assigned to one of three ESI-MC timing groups. ESI-MC will be delivered by community-based early intervention providers (EIPs) currently working within the the early intervention system in the recruitment regions. The investigators will measure child active engagement and social communication change every 6 months as the primary outcome variables. Outcome measures of developmental level, autism symptoms, and adaptive behavior will be examined to measure differential treatment effects. Maximizing the use of mobile technology, ESI-MC offers the prospect of a community-viable, scalable and sustainable treatment to improve EI services for toddlers with ASD, particularly among minority and low-resource communities.