Clinical trial NCT06523387: Online Pivotal Response Treatment Training in Autism Spectrum Disorder
Official title: Randomized Controlled Trial of an Online Pivotal Response Treatment Training in Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Autism
Keywords: Pivotal Response Treatment
Parent Training
Online Course
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 44
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a research study that will assess the effects of a Pivotal Response Treatment Online Training Course (PRT-O) for training parents of children with Autism Spectrum Disorder (ASD). The study will specifically investigate whether participants can learn to deliver PRT effectively following participation in the Online training.


Eligibility criteria: Inclusion Criteria:

* 2:0 to 5:11 years at the time of consent,
* diagnosed with ASD (based on history, review of available medical records including diagnostic testing, e.g., Autism Diagnostic Observation Schedule) or suspicion of Autism Spectrum Disorder diagnosis, and confirmed with Autism Diagnostic Interview-Revised (ADI-R),
* with significant adaptive communication deficits (i.e., either a Vineland-3 Communication subscale 2 Standard Deviations below average for 2 and 3 year olds and 3 Standard Deviations below for 4 and 5 year olds or a Vineland-3 Expressive V-scale Score 2 Standard Deviations below average for 2 and 3 year olds, or 3 Standard Deviations below for 4 and 5 year old, and at least moderate severity on the Clinical Global Impressions Severity (CGI-S) language subscale),
* an English-speaking parent able to consistently participate in study procedures and conduct treatment in English,
* 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 (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

Exclusion Criteria:

* Children who have a primary language other than English
* parent or child diagnosed with severe psychiatric disorder or unstable medical problem
* previous adequate trial of pivotal response treatment resulting in parent meeting Pivotal Response Treatment fidelity of implementation at baseline
* Receiving more than 15 hours of in home 1:1 ABA per week

Primary outcomes:
measure: Change from Baseline on Parent Fidelity of Pivotal Response Treatment Implementation as measured on the Home Video Observation (HVO)
timeFrame: 6 Weeks and 12 Weeks
measure: Change from Baseline on Child Functional Verbal Utterances as measures on the Home Video Observation (HVO)
timeFrame: 6 Weeks and 12 Weeks
Secondary outcomes:
measure: Change from Baseline on the Clinical Global Impression Scales (CGI)
timeFrame: 6 Weeks and 12 Weeks
measure: Change from Baseline on the Vineland Adaptive Behavior Scales -3 (VABS-3) Communication Domain
timeFrame: 12 Weeks
measure: Change from Baseline on the MacArthur-Bates Communication Scales (CDI)
timeFrame: 12 Weeks
Other outcomes:
measure: Change from Baseline on the Stanford Social Dimension Scale (SSDS)
timeFrame: 12 Weeks
measure: Change from Baseline on the Parent Stress Index (PSI)
timeFrame: 12 Weeks
measure: Change from Baseline on the Dimensional Assessment of Repetitive Behavior Scale (DARB)
timeFrame: 12 Weeks
measure: Change from Baseline on the Neurobehavioral Evaluation (NET) Tool
timeFrame: 12 Weeks
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Grace Gengoux, PhD
role: PRINCIPAL_INVESTIGATOR
References: