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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party):

Yale University

ClinicalTrials.gov Identifier:

NCT01691066

First received: September 19, 2012

Last updated: July 1, 2015

Last verified: July 2015

History of Changes

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:

MedlinePlus related topics: Autism Spectrum Disorder

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

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


Estimated Enrollment:	30
Study Start Date:	September 2012
Estimated Study Completion Date:	September 2015
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 (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

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

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	Katarzyna Chawarska, PhD	Yale University

More Information


Responsible Party:	Yale University
ClinicalTrials.gov Identifier:	NCT01691066 History of Changes
Other Study ID Numbers:	1110009256 R03MH092617 ( US NIH Grant/Contract Award Number )
Study First Received:	September 19, 2012
Last Updated:	July 1, 2015

Additional relevant MeSH terms:


Disease Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive	Pathologic Processes Neurodevelopmental Disorders Mental Disorders

ClinicalTrials.gov processed this record on June 28, 2017

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