Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Autism Spectrum Disorders |
Behavioral: Infant Toddler Years PRT |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder |
- Feasibility of a novel behavioral treatment [ Time Frame: 24 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Behavioral: Infant Toddler Years PRT
Other Name: Pivotal Response Treatment
|
|
No Intervention: Community Treatment
Community Treatment includes the treatments offered by early intervention services (e.g., speech-language therapy, special education instruction).
|
Eligibility| Ages Eligible for Study: | 12 Months to 15 Months |
| Genders Eligible for Study: | Both |
| 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)
Contacts and Locations| United States, Connecticut | |
| Yale Child Study Center | |
| New Haven, Connecticut, United States, 06510 | |
| Principal Investigator: | Katarzyna Chawarska, PhD | Yale University |
More Information
No publications provided
| Responsible Party: | Yale University |
| ClinicalTrials.gov Identifier: | NCT01691066 History of Changes |
| Other Study ID Numbers: | 1110009256, R03MH092617 |
| Study First Received: | September 19, 2012 |
| Last Updated: | September 21, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013