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

NCT ID: NCT04899544

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-18
• Study Completion Date: 2028-09-15

Brief 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).

Conditions

Autism; Autism Spectrum Disorder; ASD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

Pivotal Response Treatment in autism center.

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

Pivotal Response Treatment in home environment.

Treatment As Usual (TAU)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Pivotal Response Treatment in autism center.

Intervention Type: BEHAVIORAL

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

Pivotal Response Treatment in home environment.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anonymous Donor

UNKNOWN

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Antonio Hardan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Y. Hardan, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Maddy Clark

Role: CONTACT

mclark11@stanford.edu

(650)736-1235

Robin Libove

Role: CONTACT

rlibove@stanford.edu

(650)736-1235

Facility Contacts

Maddy Clark

Role: primary

mclark11@stanford.edu

650-736-1235

Anna Oft

Role: backup

autismdd@stanford.edu

650-736-1235

Other Identifiers

IRB-61427

Identifier Type: -

Identifier Source: org_study_id