Pivotal Response Treatment Package for Young Children With Autism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-04

Study Completion Date

2017-07-28

Brief Summary

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This is a research study examining the effectiveness of a pivotal response treatment package (PRT-P) in targeting language skills in young children with autism.

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Detailed Description

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Researchers at the Stanford University School of Medicine are seeking participants for a research study examining the effectiveness of a pivotal response treatment package (PRT-P) in targeting language skills in young children with autism. Research has demonstrated that behavioral interventions, such as Pivotal Response Training (PRT), lead to improvements in the core symptoms of autism. Researchers have begun to develop strategies to investigate the effectiveness of combining a parent training program teaching parents how to implement PRT with in-home, therapist-implemented treatment. To determine the effectiveness of a PRT-P, it will be compared to a delayed treatment group (DTG) by conducting a randomized controlled 24-week trial. This research will allow us to help in the development of therapeutic approaches that can meet the increasing service demands for families. We hope that investigating interventions that aim to improve core deficits will aid clinicians in providing better care for children with autism.

Conditions

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Autism Spectrum Disorder (ASD) Autism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pivotal Response Treatment Package

Pivotal Response Treatment Package (PRT-P)

Group Type EXPERIMENTAL

Pivotal Response Treatment Package (PRT-P)

Intervention Type BEHAVIORAL

Delayed Treatment Group

Delayed Treatment Group (DTG)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pivotal Response Treatment Package (PRT-P)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Autism Spectrum Disorder (ASD) based on Autism Diagnostic Interview- Revised (ADI-R), Autism Diagnostic Observation Schedule (ADOS-2), and expert clinical opinion
* Males and females in good medical health 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: Standard score at least 1 Standard Deviation below average for expressive language ability
* Stable treatment, speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation
* No more than 60 minutes of individual 1:1 speech therapy per week
* Availability of at least one parent who can consistently participate in parent training and research measures
* Parents intend on continuing Pivotal Response Treatment Package (PRT-P) for a minimum of 12 weeks
* Parents must be 18 years of age or older

Exclusion Criteria

* Current or lifetime diagnosis of severe psychiatric disorder, such as bipolar disorder
* Receiving in-home Applied Behavior Analysis (ABA) of 10 hours or more
* A genetic abnormality, such as Fragile X
* Presence of active medical problem, such as unstable seizure disorder or heart disease
* Previous adequate PRT trial
* Participants living more than 50 miles from Stanford University
* At least one room of the house must be available to be dedicated to treatment during session times
* There must be no serious health and safety risks present in the home environment
* The research team has the right to refuse to perform sessions in-home even if the criteria above are met

Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No