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Completed

NCT Number: NCT01908686

Pivotal Response Treatment for Children With Autism Spectrum Disorders

The purpose of this study is to evaluate the application of an evidence-based, manualized treatment for children with Autism Spectrum Disorder (ASD) (Pivotal Response Treatment, PRT) to children ages four through six years of age with ASD. Specifically, children will be randomly assigned to receive either (1) 10 hours per week of intervention services, including two hours per week of parent education, and eight hours per week of direct clinician-delivered services, or (2) a treatment as usual control. Intervention will focus on enhancing the following developmental skills: expressive and receptive language, play, and social interaction. Outcome measures will address changes in the aforementioned domains during structured observation and standardized assessment.

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Key information

Conditions

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

Age range

4 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale Child Study Center - Autism Program

New Haven, Connecticut, 06512, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Inclusion Criteria:

Participants will:

  • Fit the age requirement: age 4-35
  • Have been diagnosed previously with an ASD and meet criteria for ASD when characterized by research team.
  • Be in good medical health
  • Be cooperative with testing
  • English is a language spoken in the family
  • Successfully complete an fMRI and EEG scan
  • Full-scale IQ>50

Exclusion criteria

  • Exclusion Criteria:

Participants may not have:

  • Any metal or electromagnetic implants, including:
  • Cardiac pacemaker
  • Defibrillator
  • Artificial heart valve
  • Aneurysm clip
  • Cochlear implants
  • Shrapnel
  • Neurostimulators
  • History of metal fragments in eyes or skin
  • Significant hearing loss or other severe sensory impairment
  • A fragile health status.
  • Current use of prescription medications that may affect cognitive processes under study.
  • A history of significant head trauma or serious brain or psychiatric illness

Treatment and study plan

Pivotal Response Training

Behavioral

Behavioral intervention for autism

Other names: Pivotal Response Treatment

Primary outcomes

  1. Social Responsiveness Scale (SRS) Total Score

    Time frame: 16 weeks

Secondary outcomes

  1. Clinical Global Impressions Scale (CGI-I)

    Time frame: 16 weeks

  2. Autism Diagnostic Observation Schedule (ADOS) Comparison Score

    Time frame: 16 weeks

  3. Aberrant Behavior Checklist (ABC)

    Time frame: 16 weeks

  4. Vineland Domain Scores

    Time frame: 16 weeks

  5. Change in Eye Tracking (ET) patterns

    Time frame: 16 weeks

  6. Change in neural response to social stimuli using fMRI

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Acronym: PRT

Important dates

Study start
2012
Primary completion
2019
Study completion
2020
First posted
Jul 26, 2013
Registry last updated
Aug 14, 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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