A Center Based Study of Pivotal Response Treatment for Preschoolers With Autism (NCT03778827) | Clinical Trial Compass
CompletedNot Applicable
A Center Based Study of Pivotal Response Treatment for Preschoolers With Autism
United States75 participantsStarted 2019-05-13
Plain-language summary
The purpose of this study is to examine the effectiveness of pivotal response training (PRT) in an intensive center-based environment to treat social communication deficits in children with autism spectrum disorder (ASD).
Who can participate
Age range2 Years – 3 Years
SexALL
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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).
What they're measuring
1
Mean Change from baseline on the Social Responsiveness Scale-2 Total Score at 12 Weeks
Timeframe: Baseline and Week 12
2
Mean change from baseline on the Brief Observation of Communication Change (BOSCC) total score at 12 Weeks
Timeframe: Baseline and Week 12
3
Mean change from baseline on the frequency if the child's functional utterances on the structured lab observation at 12 Weeks