Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder
2 other identifiers
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 19, 2012
CompletedFirst Posted
Study publicly available on registry
September 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2017
CompletedJune 26, 2020
June 1, 2020
4.5 years
September 19, 2012
June 24, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Feasibility of a novel behavioral treatment
Assessment of Outcome: Attendance. Attendance to parent education sessions will be recorded by the therapist. Parent utilization. To assess the acceptability of the PRT approach, parents will be asked to keep a weekly log of procedure use, including overall estimated duration and choice of activities.
24 months
Acceptability of a novel behavioral treatment
Assessment of Outcome: Parent satisfaction. At post-treatment, parents will be asked to complete a Likert-scale and short response questionnaire rating their satisfaction with various aspects of the program
24 months
Study Arms (2)
Infant Toddler Years PRT
EXPERIMENTALInfant 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.
Community Treatment
NO INTERVENTIONCommunity Treatment includes the treatments offered by early intervention services (e.g., speech-language therapy, special education instruction).
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- physical or neurological disorder (e.g., seizures, cerebral palsy)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Yale Child Study Center
New Haven, Connecticut, 06510, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katarzyna Chawarska, PhD
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2012
First Posted
September 24, 2012
Study Start
September 1, 2012
Primary Completion
February 27, 2017
Study Completion
February 27, 2017
Last Updated
June 26, 2020
Record last verified: 2020-06