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

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT04899544
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 5 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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).

Key Dates

Start date
Oct 18, 2022
Status verified
Jan 2026
Primary completion
Sep 15, 2028
Completion
Sep 15, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.
  • No Intervention: 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.

Primary Outcome Measure

Change in Number of Child Utterances during the Parent-Child portion of the Structured Lab Observation (SLO). [ Time Frame: Baseline,16 Weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicineStanfordCalifornia94305
Maddy Clark
[email protected]
650-736-1235
Anna Oft
[email protected]
650-736-1235
Antonio Y Hardan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Stanford, CA

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Stanford University School of Medicine· Stanford, CA

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