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

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01691066
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 53.9
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Sep 1, 2012
• Actual Primary Completion Date: Feb 27, 2017
• Actual Study Completion Date: Feb 27, 2017

Arms and Interventions

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 Names: 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

Primary Outcome Measures

1. Feasibility of a novel behavioral treatment [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 [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

Criteria

• Ages Eligible for Study: 12 Months to 15 Months
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT01691066
• Other Study ID Numbers: 1110009256; R03MH092617
• First Posted: Sep 24, 2012
• Last Update Posted: Jun 26, 2020
• Last Verified: Jun 1, 2020

• Additional relevant MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive

Study Results

No Results Posted as of Jun 26, 2020