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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
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Yale University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorders Behavioral: Infant Toddler Years PRT Not Applicable

Study Design
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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

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Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
 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).


Outcome Measures
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Primary Outcome Measures :
  1. 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.


  2. 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



Eligibility Criteria
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Ages Eligible for Study:   12 Months to 15 Months   (Child)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
United States, Connecticut
Yale Child Study Center
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Katarzyna Chawarska, PhD Yale University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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