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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014