Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT03583684
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 4 Years
Healthy Volunteers
Not accepted

Interventions

  • Pivotal Response Treatment Program (PRT-P) — BEHAVIORAL
    The Pivotal Response Treatment Program (PRT-P) will consist of 3 parent-only sessions (60-90 min) and 13 family sessions with the parent and child (60-90 min). These 16 sessions are once per week over a 16 week period.

Study Details

Autism spectrum disorder (ASD) is a very heterogeneous disorder with limited empirically validated behavioral and biological interventions. The goal of this pilot investigation is to apply a biologically-based approach to identify predictors of treatment response in children with ASD who are receiving Pivotal Response Treatment (PRT), an evidence-based behavioral intervention. Specifically, the investigators propose to identify neuroimaging biomarkers of treatment response to a PRT program (PRT-P) targeting language deficits in young children with ASD who will be randomized to either PRT-P or to a delayed treatment group (DTG).

Key Dates

Start date
Dec 7, 2018
Status verified
Nov 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

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

Arms

  • Experimental: Pivotal Response Treatment Program (PRT-P)
    The Pivotal Response Treatment Program (PRT-P) will consist of 3 parent-only sessions (60-90 min) and 13 family sessions with the parent and child (60-90 min). These 16 sessions are once per week over a 16 week period.
  • No Intervention: Delayed Treatment Group (DTG)
    Child continues stable treatments as usual in the community.

Primary Outcome Measure

Change in Number of Child Utterances During a Structured Lab Observation (SLO) [ Time Frame: Baseline, 16 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305-5719
Estefania Millan, MA
(650) 736-1235
Robin Libove, BS
(650) 736-1235
Antonio Y. Hardan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Stanford, CA

By specialty

Related Studies