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Completed

NCT Number: NCT01691066

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

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.

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Key information

Conditions

Autism Spectrum Disorders Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

12 month–15 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale Child Study Center

New Haven, Connecticut, 06510, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Infant Toddler Years PRT

Behavioral

Other names: Pivotal Response Treatment

Primary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Sep 24, 2012
Registry last updated
Jun 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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