Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children with Autism

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 4
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Stanford University
RECRUITING
Stanford
Contact Information
Primary
Estefania Millan, MA
mmillan2@stanford.edu
(650) 736-1235
Backup
John Hegarty, PhD
hegartyj@stanford.edu
(650) 736-1235
Time Frame
Start Date: 2018-12-07
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 36
Treatments
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.
No_intervention: Delayed Treatment Group (DTG)
Child continues stable treatments as usual in the community.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
Leads: Stanford University

This content was sourced from clinicaltrials.gov