ASD, Autism, Autism Spectrum Disorder
Conditions
Keywords
pivotal response treatment, PRT, center based, social and communication
Brief summary
The aim of this clinical trial is to compare the efficacy of a 16-week center-based Pivotal Response Treatment (PRT-C) versus home-based Pivotal Response Treatment (PRT-H) in targeting social communication deficits in young children with autism spectrum disorder (ASD) with significant language delay. The two groups will also be compared to a control group that consists of children who are receiving treatment as usual (TAU).
Interventions
BEHAVIORALCenter-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)
Pivotal Response Treatment in autism center.
BEHAVIORALHome-Based Pivotal Response Treatment (PRT Intervention (PRT-H)
Pivotal Response Treatment in home environment.
Sponsors
Stanford University
Anonymous Donor
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome raters and video coding rating are blinded to group.
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Autism Spectrum Disorder (ASD) based on Autism Diagnostic Interview Revised (ADI-R), Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) or Childhood Autism Rating Scale, Second Edition (CARS-2), Diagnostic and Statistical Manual 5th Edition (DSM-5), and expert clinical opinion; * Boys and girls between 2.0 and 5.11 years; * Ability 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): Standard score at least 1 standard deviation below average for expressive language ability for 2 and 3 year olds; 2 standard deviations for 4 year olds, and 3 standard deviations for 5 year olds; * Stable treatment (e.g., Applied Behavior Analysis - ABA), speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements; * No anticipated changes on treatment during study participation for Center-Based Pivotal Response Treatment (PRT-C) and In-Home Pivotal Response Treatment (PRT-H); * No more than 60 minutes of individual 1:1 speech therapy per week; * Availability of at least one parent or primary caregiver who can consistently participate in parent training and research measures.
Exclusion criteria
* Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.); * Receiving ABA of 15 hours or more; * Presence of active medical problem (e.g., unstable seizure disorder or heart disease); * Previous adequate Pivotal Response Treatment (PRT) trial; * Participants living more than 30 miles from Stanford University; * Child's primary language other than English.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Number of Child Utterances during the Parent-Child portion of the Structured Lab Observation (SLO). | Baseline,16 Weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change on MacArthur-Bates Communication Development Inventory (CDI) Scores | Baseline,16 Weeks. | — |
| Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores | Baseline,16 Weeks. | — |
| Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) Scores | Baseline,16 Weeks. | Social Responsiveness Scale, 2nd Edition (SRS-2) scores measure social abilities with lower scores meaning better social abilities. |
| Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores | Baseline,16 Weeks. | Higher Scores on the Stanford Social Dimension Scale mean better social functioning and lower scores mean worse social functioning (Range: 58-290). |
| Change on the Brief Observation of Social Communication Change (BOSCC) direct child observation assessment. | Baseline,16 Weeks. | — |
| Change on the Clinical Global Impressions (CGI) Scale. | Baseline,16 Weeks. | — |
Countries
United States
Contacts
CONTACTMaddy Clark
CONTACTBeatrice Begley
PRINCIPAL_INVESTIGATORAntonio Y. Hardan, MD
Stanford University
Outcome results
None listed