Intensive treatment for preschoolers with autism using pivotal response training
A Center Based Randomized Controlled Trial of Pivotal Response Treatment for Preschoolers with Autism
This study tests whether a special training program for parents and preschoolers with autism can improve social communication skills better than waiting for treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 2 Years to 3 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT03778827 on ClinicalTrials.gov |
What this trial studies
This study examines the effectiveness of pivotal response training (PRT) in a center-based preschool environment to address social communication deficits in children with autism spectrum disorder (ASD). It compares the outcomes of children receiving PRT combined with parent training to those in a delayed treatment group. The study will involve 44 children aged 2 to 3.11 years diagnosed with ASD, utilizing established diagnostic tools to confirm eligibility. The intervention aims to provide a naturalistic behavioral approach based on applied behavior analysis principles.
Who should consider this trial
Good fit: Ideal candidates are children aged 2 to 3.11 years diagnosed with autism spectrum disorder and exhibiting social communication deficits.
Not a fit: Patients who are not within the specified age range or do not have a diagnosis of autism spectrum disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve social communication skills in young children with autism.
How similar studies have performed: Previous studies have shown promising results for pivotal response training in improving outcomes for children with autism, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Autism 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 Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2) or Childhood Autism Rating Scale (CARS-2); Diagnostic and Statistical Manual, 5th edition (DSM-5), and expert clinical opinion * Boys and girls between 2 years and 3 years and 11 months * Ability to participate in the testing procedures to the extent that valid standard scores can be obtained * Stable treatment (e.g., applied behavior analysis (ABA), speech therapy, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation * Developmentally delayed with Mullen Scales of Early Learning (MSEL) or Developmental Profile (DP-4) composite score below 85 (1 Standard Deviation below the mean) * Availability of at least one English-speaking parent 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.) * Presence of active medical problem (e.g., unstable seizure disorder or heart disease) * Child primary language other than English * Previous adequate trial of Pivotal Response Treatment * More than 15 hours per week of in-home applied behavior analysis (ABA).
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: Anna Oft, BS
- Email: aoft@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.