Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism (PRT-I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03583684
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Antonio Hardan, Stanford University

Brief Summary:
Autism spectrum disorder (ASD) is a very heterogeneous disorder with limited empirically validated behavioral and biological interventions. The goal of this pilot investigation is to apply a biologically-based approach to identify predictors of treatment response in children with ASD who are receiving Pivotal Response Treatment (PRT), an evidence-based behavioral intervention. Specifically, the investigators propose to identify neuroimaging biomarkers of treatment response to a PRT program (PRT-P) targeting language deficits in young children with ASD who will be randomized to either PRT-P or to a delayed treatment group (DTG).

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism
Actual Study Start Date : December 7, 2018
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pivotal Response Treatment Program (PRT-P)
The Pivotal Response Treatment Program (PRT-P) will consist of 3 parent-only sessions (60-90 min) and 13 family sessions with the parent and child (60-90 min). These 16 sessions are once per week over a 16 week period.
Behavioral: Pivotal Response Treatment Program (PRT-P)
The Pivotal Response Treatment Program (PRT-P) will consist of 3 parent-only sessions (60-90 min) and 13 family sessions with the parent and child (60-90 min). These 16 sessions are once per week over a 16 week period.
Other Name: Pivotal Response Treatment

No Intervention: Delayed Treatment Group (DTG)
Child continues stable treatments as usual in the community.



Primary Outcome Measures :
  1. Change in Number of Child Utterances During a Structured Lab Observation (SLO) [ Time Frame: Baseline, 16 Weeks ]

Secondary Outcome Measures :
  1. Change on MacArthur-Bates Communication Development Inventory (CDI) [ Time Frame: Baseline, 16 Weeks ]

Other Outcome Measures:
  1. Change on Preschool Language Scale, 5th Edition (PLS-5) [ Time Frame: Baseline, 16 Weeks ]
  2. Change on Mullen Scales of Early Learning [ Time Frame: Baseline, 16 Weeks ]
  3. Change on Vineland Adaptive Behaviors Scales, 3rd Edition [ Time Frame: Baseline, 16 Weeks ]
  4. Change on Clinical Global Impressions Scale (CGI) [ Time Frame: Baseline, 16 Weeks ]
  5. Change on the Brief Observation of Social Communication Change (BOSCC) direct child observation assessment [ Time Frame: Baseline, 16 Weeks ]
  6. Change on Parent Stress Index (PSI) [ Time Frame: Baseline, 16 Weeks ]
  7. Change on Family Empowerment Scale (FES) [ Time Frame: Baseline, 16 Weeks ]
  8. Change on General Self Efficacy Scale (GSES) [ Time Frame: Baseline, 16 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.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Autism Spectrum Spectrum Disorder (ASD) based on clinical interview and Diagnostic and Statistical Manual, 5th edition (DSM-5) and confirmed using the Autism Diagnostic Interview Revised (ADI-R) and the Autism Diagnostic Observation Schedule (ADOS),
  • Outpatients between 2.0 and 4.11 years of age of either gender,
  • Children of all cognitive levels will be included as long as they are able 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, 5th Edition (PLS-5) [at least 1 standard deviation behind for children age 2 and 3 years; and 2 standard deviations behind for children age 4],
  • Stable psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation,
  • Stable treatment [Applied Behavior Analysis (ABA), Floortime, or other interventions], speech therapy, and school placement for at least 1 month prior to baseline measurements with no expected changes during study participation,
  • No more than 60 minutes of 1:1 speech therapy per week,
  • The child's exposure to the English language must be sufficient that administration of standardized tests in English is appropriate for measuring progress,
  • The availability of at least one parent who can consistently participate in the training sessions and related activities, and
  • Successful completion of baseline brain scan.

Exclusion Criteria:

  • Current or life-time diagnosis of severe psychiatric disorder (e.g., bipolar disorder),
  • Genetic abnormality (e.g., Fragile X)
  • Presence of active medical problem (e.g., unstable seizure disorder),
  • Receiving more than 15 hours of in home 1:1 Applied Behavior Analysis (ABA) per week
  • Magnetic Resonance (MR) contraindication (e.g., the presence of ferrous metal), or
  • Previous adequate Pivotal Response Treatment (PRT) trial.

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): NCT03583684


Contacts
Layout table for location contacts
Contact: Jaelyn Edwards, BS (650) 736-1235 jedwrds@stanford.edu
Contact: John Hegarty, PhD (650) 736-1235 hegartyj@stanford.edu

Locations
Layout table for location information
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305-5719
Contact: Jaelyn Edwards, BS    650-736-1235    jedwrds@stanford.edu   
Contact: Robin Libove, BS    (650) 736-1235    rlibove@stanford.edu   
Principal Investigator: Antonio Y. Hardan, MD         
Sponsors and Collaborators
Stanford University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Layout table for investigator information
Principal Investigator: Antonio Hardan, MD Stanford University

Layout table for additonal information
Responsible Party: Antonio Hardan, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT03583684     History of Changes
Other Study ID Numbers: IRB-46131
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antonio Hardan, Stanford University:
Pivotal Response Treatment
Imaging
Additional relevant MeSH terms:
Layout table for MeSH terms
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders