Changing Developmental Trajectories Through Early Treatment

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

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.

Study Overview

• Status: Terminated
• Conditions: Autism Spectrum Disorders
• Intervention / Treatment: Behavioral: Group-ESI; Behavioral: Individual-ESI

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Marcus Autism Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 2 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group-ESI; Infants 12 months of age at risk of developing ASD who are randomized to receive the Group-ESI intervention for 9 months.	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.
Experimental: Individual-ESI plus Group-ESI; Infants 12 months of age at risk of developing ASD who are randomized to receive Individual-ESI intervention in addition to the Group-ESI intervention for 9 months.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Communication and Symbolic Behavior Scales (CSBS) Score	Social communication skills were measured with the Communication and Symbolic Behavior Scales (CSBS) Behavior Sample. Interactions between the child and caregiver were videotaped and later converted to scores. The standardized total score has a mean of 100 and standard deviation of 15. Scores below 100 indicate below average performance with the social, speech, and symbolic composites.	Baseline (12 months of age, prior to treatment), 15, 21, and 24 months of age
Autism Diagnostic Observation Schedule (ADOS) Score	Autism symptoms were measured with the Autism Diagnostic Observation Schedule, Second Edition which is the best gold standard diagnostic measure of ASD. The revised algorithms forming Social-Affect and Restricted Repetitive Behavior ratings of autism symptoms were used. A total of score of 1 to 3 indicates no signs of autism, a score of 4 or 5 suggests that the child may have autism spectrum disorder, while a score of 6 to 10 is indicative of autism.	15, 24, and 36 months of age
Mullen Scales of Early Learning (MSEL) Score	The Mullen Scales of Early Learning (MSEL) measures developmental level with standardized scores in five domains: Visual Reception, Receptive Language, Expressive Language, Fine Motor Skills, and Gross Motor Skills. Domain scores are represented in T-scores, with a mean of 50 and standard deviation of 10. A Verbal Composite score is calculated by averaging T-scores of the domains for Receptive and Expressive Language. A Nonverbal Composite score is calculated by averaging T-scores for Visual Reception and Fine Motor domains. Scores below 50 indicate below average performance.	Baseline (12 months of age, prior to treatment), 24, and 36 months of age
Vineland Adaptive Behavior Scales, Second Edition (Vineland II) Score	The Vineland II assesses adaptive behavior by providing a standard score in four domains of Communication, Daily Living Skills, Socialization, and Motor Skills. Domain scores and the Adaptive Behavior Composite score are standardized with a mean of 100 with a standard deviation of 15. Scores less than 100 indicate below average performance.	Baseline (12 months of age, prior to treatment), 24, and 36 months of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent Report	Parent measures of family functioning, daily hassles, and treatment satisfaction.	End of treatment (9 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expressive Language Phase	The child's expressive language phase will be determined at each assessment based on the benchmarks delineated by Tager-Flusberg and colleagues and recommended for evaluating the efficacy and comparing outcomes across NIH-funded intervention studies. Based on multiple sources of information about language benchmarks, the language will be categorized as: Preverbal Communication, First Words, Word Combinations, or Sentences, to provide a clinically meaningful measure of language outcome.	Baseline (12 months of age, prior to treatment), 15, 21, 24, and 36 months of age

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Nathan Call, PhD, Emory University, Marcus Autism Center, Children's Healthcare of Atlanta; Study Director: Amy Wetherby, Ph.D., Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): November 26, 2019
• Study Completion (Actual): November 26, 2019

Study Registration Dates

• First Submitted: November 5, 2013
• First Submitted That Met QC Criteria: November 8, 2013
• First Posted (Estimated): November 15, 2013

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: behavioral intervention; autism; toddlers; pervasive developmental disorders
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: IRB00064779; P50MH100029 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No