Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder
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ClinicalTrials.gov Identifier: NCT01691066 |
Recruitment Status
: Unknown
Verified July 2015 by Yale University.
Recruitment status was: Active, not recruiting
First Posted
: September 24, 2012
Last Update Posted
: July 2, 2015
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Condition or disease | Intervention/treatment | Phase |
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Autism Spectrum Disorders | Behavioral: Infant Toddler Years PRT | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder |
Study Start Date : | September 2012 |
Actual Primary Completion Date : | September 2014 |
Estimated Study Completion Date : | September 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Infant Toddler Years PRT
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.
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Behavioral: Infant Toddler Years PRT
Other Name: Pivotal Response Treatment
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No Intervention: Community Treatment
Community Treatment includes the treatments offered by early intervention services (e.g., speech-language therapy, special education instruction).
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- Feasibility of a novel behavioral treatment [ Time Frame: 24 months ]
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 [ Time Frame: 24 months ]
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

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Ages Eligible for Study: | 12 Months to 15 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691066
United States, Connecticut | |
Yale Child Study Center | |
New Haven, Connecticut, United States, 06510 |
Principal Investigator: | Katarzyna Chawarska, PhD | Yale University |
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT01691066 History of Changes |
Other Study ID Numbers: |
1110009256 R03MH092617 ( U.S. NIH Grant/Contract ) |
First Posted: | September 24, 2012 Key Record Dates |
Last Update Posted: | July 2, 2015 |
Last Verified: | July 2015 |
Additional relevant MeSH terms:
Disease Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive |
Pathologic Processes Neurodevelopmental Disorders Mental Disorders |