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

NCT ID: NCT01691066

Last Updated: 2020-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2017-02-27

Brief Summary

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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

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Conditions

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Autism Spectrum Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Infant Toddler Years PRT

Intervention Type BEHAVIORAL

Community Treatment

Community Treatment includes the treatments offered by early intervention services (e.g., speech-language therapy, special education instruction).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Infant Toddler Years PRT

Intervention Type BEHAVIORAL

Other Intervention Names

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Pivotal Response Treatment

Eligibility Criteria

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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)
Minimum Eligible Age

12 Months

Maximum Eligible Age

15 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katarzyna Chawarska, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale Child Study Center

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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R03MH092617

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1110009256

Identifier Type: -

Identifier Source: org_study_id

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