Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism (PRT-I)
Primary Purpose
Autism Spectrum Disorder, Autism
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pivotal Response Treatment Program (PRT-P)
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Pivotal Response Treatment, Imaging
Eligibility 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) and/or Brief Observation of Symptoms of Autism (BOSA) and/or Childhood Autism Rating Scale- Second Edition (CARS-2).
- 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.
Sites / Locations
- Stanford UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pivotal Response Treatment Program (PRT-P)
Delayed Treatment Group (DTG)
Arm Description
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.
Child continues stable treatments as usual in the community.
Outcomes
Primary Outcome Measures
Change in Number of Child Utterances During a Structured Lab Observation (SLO)
Secondary Outcome Measures
Change on MacArthur-Bates Communication Development Inventory (CDI)
Full Information
NCT ID
NCT03583684
First Posted
June 13, 2018
Last Updated
December 16, 2022
Sponsor
Stanford University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT03583684
Brief Title
Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism
Acronym
PRT-I
Official Title
Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 7, 2018 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Autism
Keywords
Pivotal Response Treatment, Imaging
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pivotal Response Treatment Program (PRT-P)
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed Treatment Group (DTG)
Arm Type
No Intervention
Arm Description
Child continues stable treatments as usual in the community.
Intervention Type
Behavioral
Intervention Name(s)
Pivotal Response Treatment Program (PRT-P)
Other Intervention Name(s)
Pivotal Response Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Number of Child Utterances During a Structured Lab Observation (SLO)
Time Frame
Baseline, 16 Weeks
Secondary Outcome Measure Information:
Title
Change on MacArthur-Bates Communication Development Inventory (CDI)
Time Frame
Baseline, 16 Weeks
Other Pre-specified Outcome Measures:
Title
Change on Preschool Language Scale, 5th Edition (PLS-5)
Time Frame
Baseline, 16 Weeks
Title
Change on Mullen Scales of Early Learning
Time Frame
Baseline, 16 Weeks
Title
Change on Vineland Adaptive Behaviors Scales, 3rd Edition
Time Frame
Baseline, 16 Weeks
Title
Change on Clinical Global Impressions Scale (CGI)
Time Frame
Baseline, 16 Weeks
Title
Change on the Brief Observation of Social Communication Change (BOSCC) direct child observation assessment
Time Frame
Baseline, 16 Weeks
Title
Change on Parent Stress Index (PSI)
Time Frame
Baseline, 16 Weeks
Title
Change on Family Empowerment Scale (FES)
Time Frame
Baseline, 16 Weeks
Title
Change on General Self Efficacy Scale (GSES)
Time Frame
Baseline, 16 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility 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) and/or Brief Observation of Symptoms of Autism (BOSA) and/or Childhood Autism Rating Scale- Second Edition (CARS-2).
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Estefania Millan, MA
Phone
(650) 736-1235
Email
mmillan2@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
John Hegarty, PhD
Phone
(650) 736-1235
Email
hegartyj@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Hardan, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5719
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Estefania Millan, MA
Phone
650-736-1235
Email
mmillan2@stanford.edu
First Name & Middle Initial & Last Name & Degree
Robin Libove, BS
Phone
(650) 736-1235
Email
rlibove@stanford.edu
First Name & Middle Initial & Last Name & Degree
Antonio Y. Hardan, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
We will submit de-identified clinical data to the NIMH Data Archive (NDA) data repository.
IPD Sharing URL
https://nda.nih.gov/contribute/sharing-regimen.html
Learn more about this trial
Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism
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