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

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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

Tracking Information
First Submitted Date  ICMJE June 13, 2018
First Posted Date  ICMJE July 11, 2018
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE December 7, 2018
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2018)
Change in Number of Child Utterances During a Structured Lab Observation (SLO) [ Time Frame: Baseline, 16 Weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03583684 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2018)
Change on MacArthur-Bates Communication Development Inventory (CDI) [ Time Frame: Baseline, 16 Weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 10, 2018)
  • Change on Preschool Language Scale, 5th Edition (PLS-5) [ Time Frame: Baseline, 16 Weeks ]
  • Change on Mullen Scales of Early Learning [ Time Frame: Baseline, 16 Weeks ]
  • Change on Vineland Adaptive Behaviors Scales, 3rd Edition [ Time Frame: Baseline, 16 Weeks ]
  • Change on Clinical Global Impressions Scale (CGI) [ Time Frame: Baseline, 16 Weeks ]
  • Change on the Brief Observation of Social Communication Change (BOSCC) direct child observation assessment [ Time Frame: Baseline, 16 Weeks ]
  • Change on Parent Stress Index (PSI) [ Time Frame: Baseline, 16 Weeks ]
  • Change on Family Empowerment Scale (FES) [ Time Frame: Baseline, 16 Weeks ]
  • Change on General Self Efficacy Scale (GSES) [ Time Frame: Baseline, 16 Weeks ]
Original Other Pre-specified Outcome Measures
 (submitted: June 28, 2018)
  • Change on Preschool Language Scale, 5th Edition (PLS-5) [ Time Frame: Baseline, 16 Weeks ]
  • Change on Mullen Scales of Early Learning [ Time Frame: Baseline, 16 Weeks ]
  • Change on Vineland Adaptive Behaviors Scales, 3rd Edition [ Time Frame: Baseline, 16 Weeks ]
  • Change on Clinical Global Impressions Scale (CGI) [ Time Frame: Baseline, 16 Weeks ]
  • Change on Brief Observation of Social Communication Change (BOSCC) [ Time Frame: Baseline, 16 Weeks ]
 
Descriptive Information
Brief Title  ICMJE Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism
Official Title  ICMJE Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Autism Spectrum Disorder
  • Autism
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Pivotal Response Treatment Program (PRT-P)
  • No Intervention: Delayed Treatment Group (DTG)
    Child continues stable treatments as usual in the community.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 28, 2018)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 4 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jaelyn Edwards, BS (650) 736-1235 jedwrds@stanford.edu
Contact: John Hegarty, PhD (650) 736-1235 hegartyj@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03583684
Other Study ID Numbers  ICMJE IRB-46131
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Antonio Hardan, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators  ICMJE
Principal Investigator: Antonio Hardan, MD Stanford University
PRS Account Stanford University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP