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Pivotal Response Treatment for Children With Autism Spectrum Disorders (PRT)

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ClinicalTrials.gov Identifier: NCT01908686
Recruitment Status : Recruiting
First Posted : July 26, 2013
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorders Behavioral: Pivotal Response Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : May 2012
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pivotal Response Training
Pivotal Response Training with children ages 4-35 years of age with an Autism Spectrum Disorder diagnosis
Behavioral: Pivotal Response Training
Behavioral intervention for autism
Other Name: Pivotal Response Treatment

No Intervention: Waitlist Control
Children in WL will be offered treatment following WL condition.



Primary Outcome Measures :
  1. Social Responsiveness Scale (SRS) Total Score [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion Criteria:

Participants will:

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

Exclusion Criteria:

  • Exclusion Criteria:

Participants may not have:

  1. Any metal or electromagnetic implants, including:

    1. Cardiac pacemaker
    2. Defibrillator
    3. Artificial heart valve
    4. Aneurysm clip
    5. Cochlear implants
    6. Shrapnel
    7. Neurostimulators
    8. History of metal fragments in eyes or skin
  2. Significant hearing loss or other severe sensory impairment
  3. A fragile health status.
  4. Current use of prescription medications that may affect cognitive processes under study.
  5. A history of significant head trauma or serious brain or psychiatric illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01908686


Contacts
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Contact: Jiedi Lei 203 737 4378 jiedi.lei@yale.edu

Locations
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United States, Connecticut
Yale Child Study Center - Autism Program Recruiting
New Haven, Connecticut, United States, 06512
Contact: Pamela Ventola, Ph.D       Pamela.Ventola@yale.edu   
Principal Investigator: Kevin Pelphrey, Ph.D         
Sub-Investigator: Pamela Ventola, Ph.D         
Sponsors and Collaborators
Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01908686     History of Changes
Other Study ID Numbers: 1106008625
First Posted: July 26, 2013    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018

Keywords provided by Yale University:
ASD

Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders