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

Stanford University

Status: Enrolling

Conditions: Autism Spectrum Disorder; ASD; Autism

Treatments: Behavioral: Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C); Behavioral: Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H)

Study type: Interventional

Funder types: Other

Identifiers

NCT04899544

IRB-61427

Details and patient eligibility

About

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).

Enrollment: 120 estimated patients

Sex: All

Ages: 2 to 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)

Experimental group

Description:

A 16-week center-based PRT intervention (PRT-C) consisting of 12 hours per week including 1 hour of parent training. This intervention targets social communication deficits.

Treatment:

Behavioral: Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)

Home-Based Pivotal Response Treatment (PRT) Intervention (PRT-H)

Experimental group

Description:

A 16-week home-based PRT intervention (PRT-H) consisting of 12 hours per week including 1 hour of parent training. This intervention targets social communication deficits.

Treatment:

Behavioral: Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H)

Treatment As Usual (TAU)

No Intervention group

Description:

This is a control group that consists of children who are receiving treatment as usual (TAU) for a 16-week period. These families will be invited to participate in PRT after completing the 16-week TAU phase.