Autism Spectrum DisordersPRTNCT01908686
Pivotal Response Treatment for Children With Autism Spectrum Disorders
A study testing Pivotal Response Training in people with Autism Spectrum Disorders, run by Yale University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 35 years
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- Pivotal Response Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants will:
- Fit the age requirement: age 4-35
- Have been diagnosed previously with an ASD and meet criteria for ASD when characterized by research team.
- Be in good medical health
- Be cooperative with testing
- English is a language spoken in the family
- Successfully complete an fMRI and EEG scan
- Full-scale IQ>50
Who cannot join
- Participants may not have:
- Any metal or electromagnetic implants, including:
- Cardiac pacemaker
- Defibrillator
- Artificial heart valve
- Aneurysm clip
Show all 14Show fewer
- Cochlear implants
- Shrapnel
- Neurostimulators
- History of metal fragments in eyes or skin
- Significant hearing loss or other severe sensory impairment
- A fragile health status.
- Current use of prescription medications that may affect cognitive processes under study.
- A history of significant head trauma or serious brain or psychiatric illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Child Study Center - Autism Program
New Haven, Connecticut, 06512
About this study
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.
- Conditions
- Autism Spectrum Disorders
- Being tested
- Pivotal Response Training
- Keywords
- ASD
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pivotal Response TrainingBehavioural
Also called Pivotal Response Treatment
Behavioral intervention for autism
| Study group | Role | What they receive |
|---|---|---|
| Pivotal Response Training | Active comparator | Pivotal Response Training with children ages 4-35 years of age with an Autism Spectrum Disorder diagnosis Receives: Behavioral: Pivotal Response Training |
| Waitlist Control | No intervention | Children in WL will be offered treatment following WL condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Responsiveness Scale (SRS) Total Score
Measured: 16 weeks
Secondary outcomes (6)
Clinical Global Impressions Scale (CGI-I)
Measured: 16 weeks
Autism Diagnostic Observation Schedule (ADOS) Comparison Score
Measured: 16 weeks
Aberrant Behavior Checklist (ABC)
Measured: 16 weeks
Vineland Domain Scores
Measured: 16 weeks
Change in Eye Tracking (ET) patterns
Measured: 16 weeks
Change in neural response to social stimuli using fMRI
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startMay 2012
- Primary completion1 Dec 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908686
- Sponsor's protocol ID
- 1106008625
- Other IDs
- 2R01NS035193-18
- Acronym
- PRT
- Status last verified
- Aug 2020
- First submitted
- 22 Jul 2013
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Response Treatment for Children With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT01908686
- Acronym / sponsor ID
- PRT / 1106008625
- Conditions
- Autism Spectrum Disorders
- Keywords
- ASD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- May 2012
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 26 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pivotal Response Training | Active comparator | Behavioral: Pivotal Response TrainingPivotal Response Training with children ages 4-35 years of age with an Autism Spectrum Disorder diagnosis |
| Waitlist Control | No intervention | –Children in WL will be offered treatment following WL condition. |
Who may qualify
- Ages
- 4 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Fit the age requirement: age 4-35
- Have been diagnosed previously with an ASD and meet criteria for ASD when characterized by research team.
- Be in good medical health
- Be cooperative with testing
- English is a language spoken in the family
Key exclusion criteria (14 listed)
- Any metal or electromagnetic implants, including:
- Significant hearing loss or other severe sensory impairment
- A fragile health status.
- Current use of prescription medications that may affect cognitive processes under study.
- A history of significant head trauma or serious brain or psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pivotal Response TrainingAlso: Pivotal Response TreatmentBehavioral intervention for autism | Behavioural | Pivotal Response Training |
Primary outcome
Social Responsiveness Scale (SRS) Total Score
Time frame: 16 weeks
6 secondary outcomes
Clinical Global Impressions Scale (CGI-I)
Time frame: 16 weeks
Autism Diagnostic Observation Schedule (ADOS) Comparison Score
Time frame: 16 weeks
Aberrant Behavior Checklist (ABC)
Time frame: 16 weeks
Vineland Domain Scores
Time frame: 16 weeks
Change in Eye Tracking (ET) patterns
Time frame: 16 weeks
Change in neural response to social stimuli using fMRI
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pivotal Response Training in people with Autism Spectrum Disorders, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Responsiveness Scale (SRS) Total Score (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.