Clinical trial NCT03583684: Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children with Autism
Official title: Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children with Autism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Autism
Keywords: Pivotal Response Treatment
Imaging
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2018-07-11
Enrollment: 36
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Change in Number of Child Utterances During a Structured Lab Observation (SLO)
timeFrame: Baseline, 16 Weeks
Secondary outcomes:
measure: Change on MacArthur-Bates Communication Development Inventory (CDI)
timeFrame: Baseline, 16 Weeks
Other outcomes:
measure: Change on Preschool Language Scale, 5th Edition (PLS-5)
timeFrame: Baseline, 16 Weeks
measure: Change on Mullen Scales of Early Learning
timeFrame: Baseline, 16 Weeks
measure: Change on Vineland Adaptive Behaviors Scales, 3rd Edition
timeFrame: Baseline, 16 Weeks
measure: Change on Clinical Global Impressions Scale (CGI)
timeFrame: Baseline, 16 Weeks
measure: Change on the Brief Observation of Social Communication Change (BOSCC) direct child observation assessment
timeFrame: Baseline, 16 Weeks
measure: Change on Parent Stress Index (PSI)
timeFrame: Baseline, 16 Weeks
measure: Change on Family Empowerment Scale (FES)
timeFrame: Baseline, 16 Weeks
measure: Change on General Self Efficacy Scale (GSES)
timeFrame: Baseline, 16 Weeks
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Antonio Hardan, MD
role: PRINCIPAL_INVESTIGATOR
References: