This trial is active, not recruiting.

Condition autism spectrum disorders
Treatment infant toddler years prt
Sponsor Yale University
Collaborator National Institute of Mental Health (NIMH)
Start date September 2012
End date September 2014
Trial size 30 participants
Trial identifier NCT01691066, 1110009256, R03MH092617


The purpose of this study aims to investigate the utility of Pivotal Response Treatment (PRT), a behaviorally derived intervention, to improve the quality and frequency of communication and social engagement of toddlers with siblings who have an autism spectrum disorder (SIBS - ASD) and who demonstrate developmental delays and impairments in social interaction between 12 and 15 months of age.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Infant Toddler PRT in an evidence-based, manualized treatment for children with autism spectrum disorder that involves specific motivational behavioral procedures adapted to be developmentally appropriate for 12-15 month old infants who present with developmental delays.
infant toddler years prt Pivotal Response Treatment
(No Intervention)
Community Treatment includes the treatments offered by early intervention services (e.g., speech-language therapy, special education instruction).

Primary Outcomes

Feasibility of a novel behavioral treatment
time frame: 24 months
Acceptability of a novel behavioral treatment
time frame: 24 months

Eligibility Criteria

Male or female participants from 12 months up to 15 months old.

Inclusion Criteria: - toddlers, age 12 - 15 months, who have an older sibling with ASD - delays of at least 1.5 standard deviations in communication (receptive/expressive language) based on developmental testing - scores that exceed the ASD cutoff on standardized measures of social-communicative behavior Exclusion Criteria: - physical or neurological disorder (e.g., seizures, cerebral palsy)

Additional Information

Official title Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder
Principal investigator Katarzyna Chawarska, PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Yale University.