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Pivotal Response Treatment Package for Young Children With Autism (PRT-P)

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ClinicalTrials.gov Identifier: NCT02037022
Recruitment Status : Completed
First Posted : January 15, 2014
Last Update Posted : July 15, 2019
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Antonio Hardan, Stanford University

Brief Summary:
This is a research study examining the effectiveness of a pivotal response treatment package (PRT-P) in targeting language skills in young children with autism.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder (ASD) Autism Behavioral: Pivotal Response Treatment Package (PRT-P) Not Applicable

Detailed Description:
Researchers at the Stanford University School of Medicine are seeking participants for a research study examining the effectiveness of a pivotal response treatment package (PRT-P) in targeting language skills in young children with autism. Research has demonstrated that behavioral interventions, such as Pivotal Response Training (PRT), lead to improvements in the core symptoms of autism. Researchers have begun to develop strategies to investigate the effectiveness of combining a parent training program teaching parents how to implement PRT with in-home, therapist-implemented treatment. To determine the effectiveness of a PRT-P, it will be compared to a delayed treatment group (DTG) by conducting a randomized controlled 24-week trial. This research will allow us to help in the development of therapeutic approaches that can meet the increasing service demands for families. We hope that investigating interventions that aim to improve core deficits will aid clinicians in providing better care for children with autism.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pivotal Response Treatment Package for Young Children With Autism
Actual Study Start Date : December 4, 2013
Actual Primary Completion Date : July 28, 2017
Actual Study Completion Date : July 28, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pivotal Response Treatment Package
Pivotal Response Treatment Package (PRT-P)
Behavioral: Pivotal Response Treatment Package (PRT-P)
No Intervention: Delayed Treatment Group
Delayed Treatment Group (DTG)



Primary Outcome Measures :
  1. Change from Baseline in communication during parent-child and clinician-child interactions at 6, 12, and 24 weeks [ Time Frame: 6, 12 and 24 weeks ]

Secondary Outcome Measures :
  1. Change from Baseline on the Preschool Language Scale, 5th Edition (PLS-5) at 12, and 24 weeks [ Time Frame: 12 and 24 weeks ]
  2. Change from Baseline on the Sensory Profile Questionnaire at 6, 12, and 24 weeks [ Time Frame: 6, 12 and 24 weeks ]
  3. Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks [ Time Frame: 6, 12 and 24 weeks ]
  4. Change from Baseline on the MacArthur-Bates Communication Development Inventory at 6, 12, and 24 weeks [ Time Frame: 6, 12 and 24 weeks ]
  5. Change from Baseline on the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at 6, 12, and 24 weeks [ Time Frame: 6, 12 and 24 weeks ]
  6. Change from Baseline on the Behavior Rating Inventory of Executive Function, Preschool (BRIEF-P) at 6, 12, and 24 weeks [ Time Frame: 6, 12 and 24 weeks ]
  7. Change from Baseline on the Parenting Stress Index (PSI) at 6, 12, and 24 weeks [ Time Frame: 6, 12, and 24 weeks ]
  8. Change from Baseline on the Family Empowerment Scale (FES) at 6, 12, and 24 weeks [ Time Frame: 6, 12, and 24 weeks ]
  9. Change from Baseline on the Clinical Global Impression Scale at 6, 12, and 24 weeks [ Time Frame: 6, 12, and 24 weeks ]
  10. Change from Baseline on the Social attention and word-learning eye tracking task at 12, and 24 weeks [ Time Frame: 12, and 24 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Autism Spectrum Disorder (ASD) based on Autism Diagnostic Interview- Revised (ADI-R), Autism Diagnostic Observation Schedule (ADOS-2), and expert clinical opinion
  • Males and females in good medical health between 2.0 and 5.11 years
  • Ability to participate in the testing procedures to the extent that valid standard scores can be obtained
  • Language delay as measured by the Preschool Language Scale: Standard score at least 1 Standard Deviation below average for expressive language ability
  • Stable treatment, speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation
  • No more than 60 minutes of individual 1:1 speech therapy per week
  • Availability of at least one parent who can consistently participate in parent training and research measures
  • Parents intend on continuing Pivotal Response Treatment Package (PRT-P) for a minimum of 12 weeks
  • Parents must be 18 years of age or older

Exclusion Criteria:

  • Current or lifetime diagnosis of severe psychiatric disorder, such as bipolar disorder
  • Receiving in-home Applied Behavior Analysis (ABA) of 10 hours or more
  • A genetic abnormality, such as Fragile X
  • Presence of active medical problem, such as unstable seizure disorder or heart disease
  • Previous adequate PRT trial
  • Participants living more than 50 miles from Stanford University
  • At least one room of the house must be available to be dedicated to treatment during session times
  • There must be no serious health and safety risks present in the home environment
  • The research team has the right to refuse to perform sessions in-home even if the criteria above are met

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): NCT02037022


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305-5719
Sponsors and Collaborators
Stanford University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Antonio Hardan, M.D. Stanford University

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Responsible Party: Antonio Hardan, Professor of Psychiatry and Behavioral Sciences, Stanford University
ClinicalTrials.gov Identifier: NCT02037022     History of Changes
Other Study ID Numbers: IRB-28314
R21DC013689 ( U.S. NIH Grant/Contract )
First Posted: January 15, 2014    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Keywords provided by Antonio Hardan, Stanford University:
Autism Spectrum Disorder (ASD)
Autism
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders