Changing Developmental Trajectories Through Early Treatment

Autism Spectrum Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01985022
• Other study ID #: IRB00064779
• Secondary ID: P50MH100029
• Status: Terminated
• Phase: N/A
• Start date: May 2013
• Est. completion date: November 26, 2019

Study information

• Verified date: May 2023
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: November 26, 2019
• Est. primary completion date: November 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Months to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autism Spectrum Disorders
• Autistic Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Marcus Autism Center	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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
Primary	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