Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01691066
First received: September 19, 2012
Last updated: September 21, 2012
Last verified: September 2012
  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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01691066

Locations
United States, Connecticut
Yale Child Study Center
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
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 April 16, 2014