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

Not Applicable

Completed

• Conditions: Autism Spectrum Disorders
• Interventions: Behavioral: Infant Toddler Years PRT

• Registration Number: NCT01691066
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-19
• Study First Submitted QC: 2012-09-19
• Study First Posted: 2012-09-24
• Primary Completion: 2017-02-27
• Study Completion: 2017-02-27
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-24
• Last Update Posted: 2020-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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Exclusion Criteria

• physical or neurological disorder (e.g., seizures, cerebral palsy)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infant Toddler Years PRT	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.

Primary Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

Yale Child Study Center; 🇺🇸 New Haven, Connecticut, United States