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.
Age range
6 Months – 6 Months
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Measure of Active Engagement and Transactional Supports (MAETS) Score
Timeframe: 9, 12, 16, 21, and 30 months of age
Communication and Symbolic Behavior Scales (CSBS) Score
Timeframe: 9, 12, 16, 21, and 30 months of age
Autism Diagnostic Observation Schedule Score
Timeframe: 9, 12, 16, 21, and 30 months of age
Mullen Scales of Early Learning Score
Timeframe: 9, 12, 16, 21, and 30 months of age
Vineland-3 Adaptive Behavior Scales Score
Timeframe: 9, 12, 16, 21, and 30 months of age
Measure of Active Engagement and Transactional Supports (MAETS) in Parents of Children Showing Signs of ASD
Timeframe: 12 months of age to 21 months of age
Communication and Symbolic Behavior Scales (CSBS) Score in Children Showing Signs of ASD
Timeframe: 12 months of age to 21 months of age
Autism Diagnostic Observation Schedule Score in Children Showing Signs of ASD
Timeframe: 12 months of age to 21 months of age
Mullen Scales of Early Learning Score in Children Showing Signs of ASD
Timeframe: 12 months of age to 21 months of age
Vineland-3 Adaptive Behavior Scales Score in Children Showing Signs of ASD
Timeframe: 12 months of age to 21 months of age