Promoting Transactional Supports to Optimize Social Communication Outcomes for Infants and Their Families

Completed · Not applicable

Conditions studied: Autism Spectrum Disorder

In brief

This early treatment project is designed to address two significant public health challenges - the need for validated, manualized, treatments for young children with Autism Spectrum Disorder (ASD) that are cost-efficient and feasible for community-based implementation, and the need to reduce the age of entry into early intervention to optimize outcomes. This study will use a 2-stage sequential multiple assignment randomized trial (SMART) design to develop an adaptive intervention by comparing individual and combined effects of preventative parent education and autism treatment starting in infancy. All parent-infant dyads from the pool of 250 high and low risk siblings in the Emory Autism Center of Excellence (ACE) will be invited at 6 months of age and randomly assigned at Stage 1 to the Social Communication Growth Charts (SCGC) that use an innovative web-based technology to teach parents early social communication milestones and how to support their child's development very early or Usual Care (UC), in order to compare the efficacy on developmental trajectories from 9 to 30 months. Families of children who show early signs of ASD at 12 months of age based on tailoring variables using parent report and observational measures will be re-randomized at Stage 2 to compare efficacy of a parent-implemented (P-I) condition of a naturalistic developmental behavioral intervention (NDBI) based on the Early Social Interaction (ESI)1 model to a clinician-implemented (C-I) condition of NDBI based on a hybrid model from 12 to 21 months of age. The investigators anticipate that 80 children will show early signs of ASD and that 56 families (70%) will agree to participate in the Stage 2 treatment. Growth trajectories of parent contingent responsiveness and child social communication will be collected longitudinally with repeated measures at 9, 12, 16, 21, and 30 months. Outcome measures of autism symptoms, developmental level, and adaptive behavior will be examined at 21 and 30 months to measure differential treatment effects.

Key facts

Study ID
NCT03307057
Run by
Emory University
People needed
269
Starts
2018-02-01
Expected to finish
2024-10-08
Last updated by the study team
2025-12-19

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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