Changing Developmental Trajectories Through Early Treatment

NCT01985022 | Terminated Results DMC

• 2 other identifiers: IRB00064779P50MH100029
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorders

Keywords

autism; pervasive developmental disorders; toddlers; behavioral intervention

Outcome Measures

Primary Outcomes (4)

• 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

Other Outcomes (1)

• Expressive Language Phase

  Baseline (12 months of age, prior to treatment), 15, 21, 24, and 36 months of age

Study Arms (2)

Group-ESI

ACTIVE COMPARATOR

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

Individual-ESI plus Group-ESI

EXPERIMENTAL

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; Behavioral: Individual-ESI

Interventions

Group-ESI BEHAVIORAL

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.

Group-ESI; Individual-ESI plus Group-ESI

Individual-ESI BEHAVIORAL

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.

Individual-ESI plus Group-ESI

Eligibility Criteria

• Age: 9 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• none

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Marcus Autism Center

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Child Development Disorders, Pervasive

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Nathan Call, PhD
• Organization: Emory University

nathan.call@choa.org

404-785-9400

Study Officials

• Nathan Call, PhD

  Emory University, Marcus Autism Center, Children's Healthcare of Atlanta

  PRINCIPAL INVESTIGATOR

• Amy Wetherby, Ph.D.

  Florida State University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 15, 2013
• Study Start: May 1, 2013
• Primary Completion: November 26, 2019
• Study Completion: November 26, 2019
• Last Updated: June 9, 2023
• Results First Posted: June 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)