Back to resultsPivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder
Primary Purpose
Autism Spectrum Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Infant Toddler Years PRT
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorders
Eligibility Criteria
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)
Sites / Locations
- Yale Child Study Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Infant Toddler Years PRT
Community Treatment
Arm Description
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.
Community Treatment includes the treatments offered by early intervention services (e.g., speech-language therapy, special education instruction).
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01691066
First Posted
September 19, 2012
Last Updated
June 24, 2020
Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01691066
Brief Title
Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder
Official Title
Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
February 27, 2017 (Actual)
Study Completion Date
February 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Infant Toddler Years PRT
Arm Type
Experimental
Arm Description
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.
Arm Title
Community Treatment
Arm Type
No Intervention
Arm Description
Community Treatment includes the treatments offered by early intervention services (e.g., speech-language therapy, special education instruction).
Intervention Type
Behavioral
Intervention Name(s)
Infant Toddler Years PRT
Other Intervention Name(s)
Pivotal Response Treatment
Primary Outcome Measure Information:
Title
Feasibility of a novel behavioral treatment
Description
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.
Time Frame
24 months
Title
Acceptability of a novel behavioral treatment
Description
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
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
15 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katarzyna Chawarska, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Child Study Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder
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