Autism Spectrum DisorderPhase 2NCT03370510
Translating Neuroprediction Into Precision Medicine Via Brain Priming
A Phase 2 study testing Oxytocin and Pivotal Response Treatment in people with Autism Spectrum Disorder, run by Yale University at 1 site in United States.
Trial summary
The present study examines the impact of oxytocin (OXT) and Pivotal Response Treatment (PRT) on the development of language, social, and play skills in young children with Autism Spectrum Disorder (ASD). The purpose of this study is to examine the impact of OXT as an enhancer of response to PRT. Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Oxytocin and Pivotal Response Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2018to 28 Jul 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Fit the age requirement: age 5-9
- 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
- Speak English in the family
- Successfully complete an fMRI scan
- Full-scale intelligence quotient (IQ)>70
Who cannot join
- Any metal or electromagnetic implants, including:
- Cardiac pacemaker
- Defibrillator
- Artificial heart valve
- Aneurysm clip
- Cochlear implants
Show all 13Show fewer
- 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 psychotropic 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 School of Medicine
New Haven, Connecticut, 06520
About this study
The present study examines the impact of oxytocin (OXT) and Pivotal Response Treatment (PRT) on the development of language, social, and play skills in young children with Autism Spectrum Disorder (ASD). The purpose of this study is to examine the impact of OXT as an enhancer of response to PRT. Participants will be randomly assigned to either an intranasal OXT group or a placebo group. Neither the research team nor the participants will know or choose which group the participant is assigned to. Children in both groups will participate in a 16-week trial of PRT. The trial will test the hypothesis that children with lower levels of activity in and functional connectivity among certain PRT-response brain regions will benefit more from the administration of OXT vs. placebo as an enhancer to a 16-week trial of PRT.
Read the detailed description
This project investigates the effectiveness of a new intervention approach for Autism Spectrum Disorder (ASD) to optimize the effects of an evidence-based behavioral intervention, Pivotal Response Treatment (PRT) by attempting to enhance it with oxytocin (OXT). We will integrate fMRI, eye tracking, and behavioral outcomes to measure how OXT may create a neural background for individuals with ASD to bolster their motivation to interact socially and facilitate their biological preparedness for learning social communication skills during behavioral treatments.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Oxytocin, Pivotal Response Treatment, Placebo
- 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.
OxytocinDrug
Oxytocin nasal spray.
Pivotal Response TreatmentBehavioural
An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication.
PlaceboDrug
Placebo nasal spray.
| Study group | Role | What they receive |
|---|---|---|
| Pivotal Response Treatment (PRT)/oxytocin (OXT) nasal spray | Experimental | Participants will receive oxytocin nasal spray 45 minutes prior to each PRT session. Receives: Drug: Oxytocin; Behavioral: Pivotal Response Treatment |
| Pivotal Response Treatment (PRT)/placebo nasal spray | Placebo comparator | Participants will receive a placebo nasal spray 45 minutes prior to each PRT session. Receives: Behavioral: Pivotal Response Treatment; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Responsiveness Scale, 2nd Edition (SRS-2)
The SRS-2 is a 65-item measure of social responsiveness. The SRS-2 is filled out by a parent. The SRS-2 has a minimum raw score of 0 and a maximum raw score of 195. Higher raw scores on the SRS-2 mean a worse outcome.
Measured: Change from Baseline to post-treatment, 16 weeks
Secondary outcomes (1)
Vineland Adaptive Behavior Scale, 3rd Edition (Vineland-III)
The Vineland-III is a parent interview administered by a member of the research team. The interview lasts approximately one hour and measures four domains of the child's adaptive behavior.
Measured: Change from Baseline to post-treatment, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start7 Dec 2018
- Primary completion28 Jul 2021
- Study completion28 Jul 2021
Why it stopped: Covid-19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autism Spectrum DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eighty children will be randomly assigned to receive PRT with either oxytocin (forty children) or a placebo (forty children).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis Sukhodolsky, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370510
- Sponsor's protocol ID
- 2000021581
- Status last verified
- Aug 2022
- First submitted
- 7 Dec 2017
- Last updated
- 9 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating Neuroprediction Into Precision Medicine Via Brain Priming
- ClinicalTrials.gov ID
- NCT03370510
- Acronym / sponsor ID
- 2000021581
- Conditions
- Autism Spectrum Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid-19 Pandemic
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 28 Jul 2021 (actual)
- First posted
- 12 Dec 2017 (actual)
- Results
- Posted 9 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study examines the impact of oxytocin (OXT) and Pivotal Response Treatment (PRT) on the development of language, social, and play skills in young children with Autism Spectrum Disorder (ASD). The purpose of this study is to examine the impact of OXT as an enhancer of response to PRT. Participants will be randomly assigned to either an intranasal OXT group or a placebo group. Neither the research team nor the participants will know or choose which group the participant is assigned to. Children in both groups will participate in a 16-week trial of PRT. The trial will test the hypothesis that children with lower levels of activity in and functional connectivity among certain PRT-response brain regions will benefit more from the administration of OXT vs. placebo as an enhancer to a 16-week trial of PRT.
Detailed description
This project investigates the effectiveness of a new intervention approach for Autism Spectrum Disorder (ASD) to optimize the effects of an evidence-based behavioral intervention, Pivotal Response Treatment (PRT) by attempting to enhance it with oxytocin (OXT). We will integrate fMRI, eye tracking, and behavioral outcomes to measure how OXT may create a neural background for individuals with ASD to bolster their motivation to interact socially and facilitate their biological preparedness for learning social communication skills during behavioral treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Eighty children will be randomly assigned to receive PRT with either oxytocin (forty children) or a placebo (forty children).
| Arm | Type | Receives |
|---|---|---|
| Pivotal Response Treatment (PRT)/oxytocin (OXT) nasal spray | Experimental | Drug: Oxytocin, Behavioral: Pivotal Response TreatmentParticipants will receive oxytocin nasal spray 45 minutes prior to each PRT session. |
| Pivotal Response Treatment (PRT)/placebo nasal spray | Placebo comparator | Behavioral: Pivotal Response Treatment, Drug: PlaceboParticipants will receive a placebo nasal spray 45 minutes prior to each PRT session. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Fit the age requirement: age 5-9
- 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
- Speak English in the family
Key exclusion criteria (13 listed)
- Any metal or electromagnetic implants, including:
- Significant hearing loss or other severe sensory impairment
- A fragile health status.
- Current use of prescription psychotropic 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 |
|---|---|---|
| OxytocinOxytocin nasal spray. | Drug | Pivotal Response Treatment (PRT)/oxytocin (OXT) nasal spray |
| Pivotal Response TreatmentAn evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication. | Behavioural | Pivotal Response Treatment (PRT)/oxytocin (OXT) nasal spray, Pivotal Response Treatment (PRT)/placebo nasal spray |
| PlaceboPlacebo nasal spray. | Drug | Pivotal Response Treatment (PRT)/placebo nasal spray |
Primary outcome
Social Responsiveness Scale, 2nd Edition (SRS-2)
Time frame: Change from Baseline to post-treatment, 16 weeks
The SRS-2 is a 65-item measure of social responsiveness. The SRS-2 is filled out by a parent. The SRS-2 has a minimum raw score of 0 and a maximum raw score of 195. Higher raw scores on the SRS-2 mean a worse outcome.
1 secondary outcome
Vineland Adaptive Behavior Scale, 3rd Edition (Vineland-III)
Time frame: Change from Baseline to post-treatment, 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Denis Sukhodolsky, Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxytocin and Pivotal Response Treatment in people with Autism Spectrum Disorder, 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 7 inclusion and 13 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: stopped early, as of the sponsor's last update on 9 Aug 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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, 2nd Edition (SRS-2) (time frame: Change from Baseline to post-treatment, 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 9 Aug 2022.