Autism, Autism Spectrum Disorder
Conditions
Keywords
Pivotal Response Treatment, Imaging
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).
Interventions
BEHAVIORALPivotal 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.
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 4 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Number of Child Utterances During a Structured Lab Observation (SLO) | Baseline, 16 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change on MacArthur-Bates Communication Development Inventory (CDI) | Baseline, 16 Weeks |
Other
| Measure | Time frame |
|---|---|
| Change on Vineland Adaptive Behaviors Scales, 3rd Edition | Baseline, 16 Weeks |
| Change on Clinical Global Impressions Scale (CGI) | Baseline, 16 Weeks |
| Change on the Brief Observation of Social Communication Change (BOSCC) direct child observation assessment | Baseline, 16 Weeks |
| Change on Preschool Language Scale, 5th Edition (PLS-5) | Baseline, 16 Weeks |
| Change on Family Empowerment Scale (FES) | Baseline, 16 Weeks |
| Change on General Self Efficacy Scale (GSES) | Baseline, 16 Weeks |
| Change on Parent Stress Index (PSI) | Baseline, 16 Weeks |
| Change on Mullen Scales of Early Learning | Baseline, 16 Weeks |
Countries
United States
Contacts
Primary ContactEstefania Millan, MA
Backup ContactJohn Hegarty, PhD
Outcome results
None listed