Autism Spectrum DisordersNCT01691066
Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder
A study testing Infant Toddler Years PRT in people with Autism Spectrum Disorders, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study aims to investigate the utility of Pivotal Response Treatment (PRT), a behaviorally derived intervention, to improve the quality and frequency of communication and social engagement of toddlers with siblings who have an autism spectrum disorder (SIBS - ASD) and who demonstrate developmental… Read more about this study
- Who is it for?
- Ages 12 to 15 months
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- Infant Toddler Years PRT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to 27 Feb 2017
- 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 12 to 15 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- toddlers, age 12 - 15 months, who have an older sibling with ASD
- delays of at least 1.5 standard deviations in communication (receptive/expressive language) based on developmental testing
- scores that exceed the ASD cutoff on standardized measures of social-communicative behavior
Who cannot join
- physical or neurological disorder (e.g., seizures, cerebral palsy)
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Child Study Center
New Haven, Connecticut, 06510
About this study
The purpose of this study aims to investigate the utility of Pivotal Response Treatment (PRT), a behaviorally derived intervention, to improve the quality and frequency of communication and social engagement of toddlers with siblings who have an autism spectrum disorder (SIBS - ASD) and who demonstrate developmental delays and impairments in social interaction between 12 and 15 months of age.
- Conditions
- Autism Spectrum Disorders
- Being tested
- Infant Toddler Years PRT
- 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.
Infant Toddler Years PRTBehavioural
Also called Pivotal Response Treatment
| Study group | Role | What they receive |
|---|---|---|
| Infant Toddler Years PRT | Experimental | Infant Toddler PRT in an evidence-based, manualized treatment for children with autism spectrum disorder that involves specific motivational behavioral procedures adapted to be developmentally appropriate for 12-15 month old infants who present with developmental delays. Receives: Behavioral: Infant Toddler Years PRT |
| Community Treatment | No intervention | Community Treatment includes the treatments offered by early intervention services (e.g., speech-language therapy, special education instruction). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of a novel behavioral treatment
Assessment of Outcome:
Attendance. Attendance to parent education sessions will be recorded by the therapist.
Parent utilization. To assess the acceptability of the PRT approach, parents will be asked to keep a weekly log of procedure use, including overall estimated duration and choice of activities.
Measured: 24 months
Acceptability of a novel behavioral treatment
Assessment of Outcome:
Parent satisfaction. At post-treatment, parents will be asked to complete a Likert-scale and short response questionnaire rating their satisfaction with various aspects of the program
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startSep 2012
- Primary completion27 Feb 2017
- Study completion27 Feb 2017
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Katarzyna Chawarska, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691066
- Sponsor's protocol ID
- 1110009256
- Other IDs
- R03MH092617
- Status last verified
- Jun 2020
- First submitted
- 19 Sep 2012
- Last updated
- 26 Jun 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT01691066
- Acronym / sponsor ID
- 1110009256
- Conditions
- Autism Spectrum Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2012
- Primary completion
- 27 Feb 2017 (actual)
- Study completion
- 27 Feb 2017 (actual)
- First posted
- 24 Sep 2012 (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 aims to investigate the utility of Pivotal Response Treatment (PRT), a behaviorally derived intervention, to improve the quality and frequency of communication and social engagement of toddlers with siblings who have an autism spectrum disorder (SIBS - ASD) and who demonstrate developmental delays and impairments in social interaction between 12 and 15 months of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infant Toddler Years PRT | Experimental | Behavioral: Infant Toddler Years PRTInfant Toddler PRT in an evidence-based, manualized treatment for children with autism spectrum disorder that involves specific motivational behavioral procedures adapted to be developmentally appropriate for 12-15 month old infants who present with developmental delays. |
| Community Treatment | No intervention | –Community Treatment includes the treatments offered by early intervention services (e.g., speech-language therapy, special education instruction). |
Who may qualify
- Ages
- 12 to 15 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- toddlers, age 12 - 15 months, who have an older sibling with ASD
- delays of at least 1.5 standard deviations in communication (receptive/expressive language) based on developmental testing
- scores that exceed the ASD cutoff on standardized measures of social-communicative behavior
Key exclusion criteria (1 listed)
- physical or neurological disorder (e.g., seizures, cerebral palsy)
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 |
|---|---|---|
| Infant Toddler Years PRTAlso: Pivotal Response Treatment | Behavioural | Infant Toddler Years PRT |
Primary outcome
Feasibility of a novel behavioral treatment
Time frame: 24 months
Assessment of Outcome: Attendance. Attendance to parent education sessions will be recorded by the therapist. Parent utilization. To assess the acceptability of the PRT approach, parents will be asked to keep a weekly log of procedure use, including overall estimated duration and choice of activities.
Acceptability of a novel behavioral treatment
Time frame: 24 months
Assessment of Outcome: Parent satisfaction. At post-treatment, parents will be asked to complete a Likert-scale and short response questionnaire rating their satisfaction with various aspects of the program
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 26 Jun 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.
Katarzyna Chawarska, PhD 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 study testing Infant Toddler Years PRT 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 3 inclusion and 1 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 26 Jun 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?
Feasibility of a novel behavioral treatment (time frame: 24 months). The study lists 2 primary outcomes in all. 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 26 Jun 2020.