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NCT Number: NCT04899544

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

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).

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Key information

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral

Pivotal Response Treatment in autism center.

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

Behavioral

Pivotal Response Treatment in home environment.

Primary outcomes

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

    Time frame: Baseline,16 Weeks.

Secondary outcomes

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

    Time frame: Baseline,16 Weeks.

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

    Time frame: Baseline,16 Weeks.

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

    Time frame: Baseline,16 Weeks.

    Social Responsiveness Scale, 2nd Edition (SRS-2) scores measure social abilities with lower scores meaning better social abilities.

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

    Time frame: Baseline,16 Weeks.

    Higher Scores on the Stanford Social Dimension Scale mean better social functioning and lower scores mean worse social functioning (Range: 58-290).

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

    Time frame: Baseline,16 Weeks.

  6. Change on the Clinical Global Impressions (CGI) Scale.

    Time frame: Baseline,16 Weeks.

Other outcomes

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

    Time frame: Baseline,16 Weeks.

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

    Time frame: Baseline,16 Weeks.

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

    Time frame: Baseline,16 Weeks.

  4. Change From Baseline in the Parent Rated Child and Family Quality of Life - 2 (CFQL-2) Scores

    Time frame: Baseline,16 Weeks.

  5. Change From Baseline in the Parent Rated Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P) Scores

    Time frame: Baseline,16 Weeks.

  6. Change From Baseline in the Parent Rated Family Empowerment Scale (FES) Scores

    Time frame: Baseline,16 Weeks.

  7. Change From Baseline in the Parent Rated Parent Motivation Inventory (PMI) Scores

    Time frame: Baseline,16 Weeks.

  8. Change From Baseline in the Parent Rated Parent Stress Index, Short Form (PSI/SF) Scores

    Time frame: Baseline,16 Weeks.

  9. Change From Baseline in the Parent Rated Dimensional Assessment of Repetitive Behaviors (DARB) Scores

    Time frame: Baseline,16 Weeks.

Study contacts

Contact information is provided by the study sponsor or research team.

Beatrice Begley

CONTACT

[email protected]

(650)736-1235

Maddy Clark

CONTACT

[email protected]

(650)736-1235

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Anonymous Donor

Registry information

Official study title

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

Acronym: PRT-HvC

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
May 24, 2021
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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