Clinical trial NCT01985022: Changing Developmental Trajectories Through Early Treatment
Official title: Autism Center of Excellence: Project 3 - Changing Developmental Trajectories Through Early Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Autism Spectrum Disorders
Keywords: autism
pervasive developmental disorders
toddlers
behavioral intervention
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2013-11-15
Enrollment: 33
Sex: ALL
Minimum age (years): 9
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Participants are recruited from the Emory Autism Center of Excellence Center from a pool of younger siblings who are at high or low risk of developing ASD
* For high-risk infants, a positive screen on 2 of 4 screening measures indicating the presence of diagnostic features of ASD by 12 months of age
* For low-risk infants will be a positive screen on 3 of 4 screening measures
* Families agree to twice monthly play group sessions for 9 months and 2-3 intervention sessions per week for 9 months (usually within work-day hours)

Exclusion Criteria:

* none

Primary outcomes:
measure: Communication and Symbolic Behavior Scales (CSBS) Score
timeFrame: Baseline (12 months of age, prior to treatment), 15, 21, and 24 months of age
measure: Autism Diagnostic Observation Schedule (ADOS) Score
timeFrame: 15, 24, and 36 months of age
measure: Mullen Scales of Early Learning (MSEL) Score
timeFrame: Baseline (12 months of age, prior to treatment), 24, and 36 months of age
measure: Vineland Adaptive Behavior Scales, Second Edition (Vineland II) Score
timeFrame: Baseline (12 months of age, prior to treatment), 24, and 36 months of age
Secondary outcomes:
Other outcomes:
measure: Expressive Language Phase
timeFrame: Baseline (12 months of age, prior to treatment), 15, 21, 24, and 36 months of age
Locations:
city: Atlanta
country: United States
facility: Marcus Autism Center
state: Georgia
Study officials:
affiliation: Emory University, Marcus Autism Center, Children's Healthcare of Atlanta
name: Nathan Call, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida State University
name: Amy Wetherby, Ph.D.
role: STUDY_DIRECTOR
References: