NCT04899544

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
27mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Oct 2022Sep 2028

First Submitted

Initial submission to the registry

May 19, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 24, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

October 18, 2022

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2028

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

5.9 years

First QC Date

May 19, 2021

Last Update Submit

January 10, 2026

Conditions

AutismAutism Spectrum DisorderASD

Keywords

pivotal response treatmentPRTcenter basedsocial and communication

Outcome Measures

Primary Outcomes (1)

  • Change in Number of Child Utterances during the Parent-Child portion of the Structured Lab Observation (SLO).

    Baseline,16 Weeks.

Secondary Outcomes (6)

  • Change on MacArthur-Bates Communication Development Inventory (CDI) Scores

    Baseline,16 Weeks.

  • Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores

    Baseline,16 Weeks.

  • Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) Scores

    Baseline,16 Weeks.

  • Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores

    Baseline,16 Weeks.

  • Change on the Brief Observation of Social Communication Change (BOSCC) direct child observation assessment.

    Baseline,16 Weeks.

  • +1 more secondary outcomes

Other Outcomes (9)

  • Change From Baseline in the Parent Rated Emotion Dysregulation Inventory-Young Child (EDI-YC) Scores

    Baseline,16 Weeks.

  • Change From Baseline in the Parent Rated General Self Efficacy Scale (GSES) Scores

    Baseline,16 Weeks.

  • Change From Baseline in the Parent Rated Sensory Experiences Questionnaire (SEQ) Scores

    Baseline,16 Weeks.

  • +6 more other outcomes

Study Arms (3)

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

Treatment As Usual (TAU)

NO INTERVENTION

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.

Interventions

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

Pivotal Response Treatment in home environment.

Home-Based Pivotal Response Treatment (PRT) Intervention (PRT-H)
Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)BEHAVIORAL

Pivotal Response Treatment in autism center.

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

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Autistic DisorderAutism Spectrum DisorderCommunication

Interventions

Hypoxanthine PhosphoribosyltransferaseMethods

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

PentosyltransferasesGlycosyltransferasesTransferasesEnzymesEnzymes and CoenzymesInvestigative Techniques

Study Officials

  • Antonio Y. Hardan, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maddy Clark

CONTACT

(650)736-1235mclark11@stanford.edu

Robin Libove

CONTACT

(650)736-1235rlibove@stanford.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome raters and video coding rating are blinded to group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 19, 2021

First Posted

May 24, 2021

Study Start

October 18, 2022

Primary Completion (Estimated)

September 15, 2028

Study Completion (Estimated)

September 15, 2028

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)