NCT01985022

Changing Developmental Trajectories Through Early Treatment

Autism Center of Excellence: Project 3 - Changing Developmental Trajectories Through Early Treatment

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 9 Months – 24 Months
• Healthy volunteers: Not accepted

Summary

The major objective of this research protocol is to directly compare two parent intervention conditions of Early Social Interaction (ESI) for 9 months on developmental trajectories of infants showing early risk for Autism Spectrum Disorder (ASD). Participants will be randomized to receive an information, education and support group (Group) ESI intervention offered weekly, or a parent-implemented intervention (Individual) ESI intervention offered in twice-weekly, in combination with the Group ESI intervention.

Detailed description

Mounting evidence exists of the effectiveness of intensive early intervention for a substantial proportion of children with autism spectrum disorders (ASD). Furthermore, age of entry into intervention may be predictive of outcome. Children with ASD in intensive interventions beginning by 3.5 years of age had significantly better outcomes than those beginning after age 5. These findings support the importance of early identification and intervention for improving outcomes. There is very limited research on children with ASD under 3 years of age primarily because the median age for diagnosis in the US is 5.5 years. With advances in earlier screening and diagnosis, there is a pressing need to develop early intervention programs that are appropriate and effective with very young children with ASD. The Early Social Interaction (ESI) Project is an intervention program developed for toddlers at risk for ASD and their families as a model demonstration project funded by the United States Department of Education. ESI was designed to incorporate the National Research Council (NRC) recommendations within the context of a family-centered, natural-environments approach. The major components of ESI are: 1. routines-based intervention in natural environments 2. individualized curriculum 3. parent-implemented intervention The Emory Autism Center of Excellence (ACE) will recruit parent-infant dyads at 12 months of infant's age from a pool of "High-Risk for Developing ASD" younger siblings and from a pool of low risk infants being studied at the Emory ACE. Parents are involved in the intervention itself while the study outcome measures are focused on the infants that are receiving the different interventions (demographic and outcome data are not collected on the parents of the infants). Infant participants will be randomized to receive an ESI intervention delivered in a group setting, or an individual ESI intervention combined with the group ESI. The intervention will last 9 months and infants will be followed until they reach 36 months of age.

Conditions

• Autism Spectrum Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Group-ESI	The Group-ESI intervention consists of weekly small group meetings where families receive information about social communication, emotional regulation, play development, and behavioral challenges in toddler playgroups in a relaxed, supportive, child-friendly setting that provides the opportunity to talk with a professional and meet other parents.
BEHAVIORAL	Individual-ESI	The Individual-ESI intervention consists of twice-weekly home-based individualized coaching sessions. Parents learn how to support their child's communication, social, and play skills in everyday routines, activities, and places. Individual-ESI begins with an initial home visit, followed by a month of program planning, 6 months of intervention implementation, and 2 months of generalization. During generalization, the clinician meets with the family in a variety of community settings to teach the parent how to implement strategies in new settings.

Timeline

• Start date: 2013-05-01
• Primary completion: 2019-11-26
• Completion: 2019-11-26
• First posted: 2013-11-15
• Last updated: 2023-06-09
• Results posted: 2023-06-09

Locations

1 site across 1 country: United States