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

Autism Spectrum Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01691066
• Other study ID #: 1110009256
• Secondary ID: R03MH092617
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: February 27, 2017

Study information

• Verified date: June 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 27, 2017
• Est. primary completion date: February 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 15 Months

Eligibility

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)

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autism Spectrum Disorders
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Behavioral:
• Infant Toddler Years PRT

Locations

Country	Name	City	State
United States	Yale Child Study Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of a novel behavioral treatment	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.	24 months
Primary	Acceptability of a novel behavioral treatment	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	24 months