Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism

Autism Spectrum Disorder Clinical Trial

— PRT-HvC  

Official title:

Randomized Controlled Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04899544
• Other study ID #: IRB-61427
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2022
• Est. completion date: September 15, 2026

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: Maddy Clark
• Phone: (650)736-1235
• Email: mclark11[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 15, 2026
• Est. primary completion date: September 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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 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.

Related Conditions & MeSH terms

• ASD
• Autism
• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Behavioral:
• Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)
Pivotal Response Treatment in autism center.
• Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H)
Pivotal Response Treatment in home environment.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Anonymous Donor

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in the Parent Rated Emotion Dysregulation Inventory-Young Child (EDI-YC) Scores		Baseline,16 Weeks.
Other	Change From Baseline in the Parent Rated General Self Efficacy Scale (GSES) Scores		Baseline,16 Weeks.
Other	Change From Baseline in the Parent Rated Sensory Experiences Questionnaire (SEQ) Scores		Baseline,16 Weeks.
Other	Change From Baseline in the Parent Rated Child and Family Quality of Life - 2 (CFQL-2) Scores		Baseline,16 Weeks.
Other	Change From Baseline in the Parent Rated Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P) Scores		Baseline,16 Weeks.
Other	Change From Baseline in the Parent Rated Family Empowerment Scale (FES) Scores		Baseline,16 Weeks.
Other	Change From Baseline in the Parent Rated Parent Motivation Inventory (PMI) Scores		Baseline,16 Weeks.
Other	Change From Baseline in the Parent Rated Parent Stress Index, Short Form (PSI/SF) Scores		Baseline,16 Weeks.
Other	Change From Baseline in the Parent Rated Dimensional Assessment of Repetitive Behaviors (DARB) Scores		Baseline,16 Weeks.
Primary	Change in Number of Child Utterances during the Parent-Child portion of the Structured Lab Observation (SLO).		Baseline,16 Weeks.
Secondary	Change on MacArthur-Bates Communication Development Inventory (CDI) Scores		Baseline,16 Weeks.
Secondary	Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores		Baseline,16 Weeks.
Secondary	Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) Scores	Social Responsiveness Scale, 2nd Edition (SRS-2) scores measure social abilities with lower scores meaning better social abilities.	Baseline,16 Weeks.
Secondary	Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores	Higher Scores on the Stanford Social Dimension Scale mean better social functioning and lower scores mean worse social functioning (Range: 58-290).	Baseline,16 Weeks.
Secondary	Change on the Brief Observation of Social Communication Change (BOSCC) direct child observation assessment.		Baseline,16 Weeks.
Secondary	Change on the Clinical Global Impressions (CGI) Scale.		Baseline,16 Weeks.