Comparing center-based and home-based treatment for young children with autism
Randomized Controlled Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism
This study tests whether treatment for young children with autism works better when done at a center or at home, focusing on improving their language and social skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 2 Years to 5 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT04899544 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of two different approaches to Pivotal Response Treatment (PRT) for young children with autism spectrum disorder (ASD) who have significant language delays. Participants will be divided into two groups: one receiving center-based PRT and the other receiving home-based PRT, with a control group receiving treatment as usual. The study will last for 16 weeks and will assess improvements in social communication skills. The trial will utilize standardized assessments to measure language abilities and social communication outcomes.
Who should consider this trial
Good fit: Ideal candidates are children aged 2 to 5 years diagnosed with autism spectrum disorder and experiencing significant language delays.
Not a fit: Patients who do not have a diagnosis of autism spectrum disorder or who are not experiencing language delays may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment settings for improving communication skills in young children with autism.
How similar studies have performed: Previous studies have shown varying success with Pivotal Response Treatment, but this specific comparison of center-based versus home-based approaches is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Stanford, California
- Stanford University School of Medicine — Stanford, California, United States (Recruiting)
Study contacts
- Principal investigator: Antonio Y. Hardan, MD — Stanford University
- Study coordinator: Maddy Clark
- Email: mclark11@stanford.edu
- Phone: (650)736-1235
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.