Pivotal Response Treatment for Children With Autism Spectrum Disorders

NCT ID: NCT01908686

Last Updated: 2020-08-14

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2020-03-01

Brief Summary

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The purpose of this study is to evaluate the application of an evidence-based, manualized treatment for children with Autism Spectrum Disorder (ASD) (Pivotal Response Treatment, PRT) to children ages four through six years of age with ASD. Specifically, children will be randomly assigned to receive either (1) 10 hours per week of intervention services, including two hours per week of parent education, and eight hours per week of direct clinician-delivered services, or (2) a treatment as usual control. Intervention will focus on enhancing the following developmental skills: expressive and receptive language, play, and social interaction. Outcome measures will address changes in the aforementioned domains during structured observation and standardized assessment.

Detailed Description

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Conditions

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Autism Spectrum Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Pivotal Response Training

Pivotal Response Training with children ages 4-35 years of age with an Autism Spectrum Disorder diagnosis

Group Type ACTIVE_COMPARATOR

Pivotal Response Training

Intervention Type BEHAVIORAL

Behavioral intervention for autism

Waitlist Control

Children in WL will be offered treatment following WL condition.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pivotal Response Training

Behavioral intervention for autism

Intervention Type BEHAVIORAL

Other Intervention Names

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Pivotal Response Treatment

Eligibility Criteria

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Inclusion Criteria

Participants will:

1. Fit the age requirement: age 4-35
2. Have been diagnosed previously with an ASD and meet criteria for ASD when characterized by research team.
3. Be in good medical health
4. Be cooperative with testing
5. English is a language spoken in the family
6. Successfully complete an fMRI and EEG scan
7. Full-scale IQ\>50

Exclusion Criteria

Participants may not have:

1. Any metal or electromagnetic implants, including:

1. Cardiac pacemaker
2. Defibrillator
3. Artificial heart valve
4. Aneurysm clip
5. Cochlear implants
6. Shrapnel
7. Neurostimulators
8. History of metal fragments in eyes or skin
2. Significant hearing loss or other severe sensory impairment
3. A fragile health status.
4. Current use of prescription medications that may affect cognitive processes under study.
5. A history of significant head trauma or serious brain or psychiatric illness
Minimum Eligible Age

4 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yale Child Study Center - Autism Program

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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2R01NS035193-18

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1106008625

Identifier Type: -

Identifier Source: org_study_id

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