Intellectual DisabilitiesNCT01988623
Pivotal Response Treatment for Individuals With Intellectual Disabilities
A study testing Pivotal Response Treatment (PRT) in people with Intellectual Disabilities and Speech Delay, run by Stanford University at 1 site in United States.
Trial summary
The investigators will assess the efficacy of Pivotal Response Treatment (PRT) in the treatment of communication deficits in children with intellectual disabilities. By collecting information about parent and child functioning before and after PRT, The investigators will be able to determine whether the intervention… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Intellectual Disabilities, Speech Delay, Language Disorder
- What is being tested?
- Pivotal Response Treatment (PRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2012to 30 Sep 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- medically unstable (such as having unstable seizures)
- primary diagnosis of Autism Spectrum Disorder (ASD) is exclusionary as determined by the investigators
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305-5719
About this study
The investigators will assess the efficacy of Pivotal Response Treatment (PRT) in the treatment of communication deficits in children with intellectual disabilities. By collecting information about parent and child functioning before and after PRT, The investigators will be able to determine whether the intervention is effective in improving child communication and reducing parent stress.
- Conditions
- Intellectual Disabilities, Speech Delay, Language Disorder
- Being tested
- Pivotal Response Treatment (PRT)
- Keywords
- Intellectual Disabilities, Speech Delay, Language Disorder
- Medical subject headings
- Intellectual Disability, Language Development Disorders, Language Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pivotal Response Treatment (PRT)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Pivotal Response Treatment (PRT) | Experimental | Not described Receives: Behavioral: Pivotal Response Treatment (PRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline on the MacArthur-Bates Communication Development Inventory at 6, 12, and 24 weeks
Measured: 6, 12 and 24 weeks
Change from Baseline in communication during parent-child and clinician-child interactions at 6, 12, and 24 weeks
Measured: 6, 12 and 24 weeks
Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks
Measured: 6, 12 and 24 weeks
Change from Baseline on the Clinical Global Impression Scale at 6, 12, and 24 weeks
Measured: 6, 12, and 24 weeks
Secondary outcomes (3)
Change from Baseline on the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at 6, 12, and 24 weeks
Measured: 6, 12 and 24 weeks
Change from Baseline on the Parenting Stress Index (PSI) at 6, 12, and 24 weeks
Measured: 6, 12, and 24 weeks
Change from Baseline on the Family Empowerment Scale (FES) at 6, 12, and 24 weeks
Measured: 6, 12, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study start11 Sep 2012
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilitiesStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Hardan, Stanford University
- Investigators
- Antonio Y. Hardan, M.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988623
- Sponsor's protocol ID
- IRB-25229
- Status last verified
- Jan 2021
- First submitted
- 13 Nov 2013
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Response Treatment for Individuals With Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT01988623
- Acronym / sponsor ID
- IRB-25229
- Conditions
- Intellectual Disabilities, Speech Delay, Language Disorder
- Keywords
- Intellectual Disabilities, Speech Delay, Language Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 11 Sep 2012
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 20 Nov 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 investigators will assess the efficacy of Pivotal Response Treatment (PRT) in the treatment of communication deficits in children with intellectual disabilities. By collecting information about parent and child functioning before and after PRT, The investigators will be able to determine whether the intervention is effective in improving child communication and reducing parent stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pivotal Response Treatment (PRT) | Experimental | Behavioral: Pivotal Response Treatment (PRT) |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- medically unstable (such as having unstable seizures)
- primary diagnosis of Autism Spectrum Disorder (ASD) is exclusionary as determined by the investigators
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 Treatment (PRT) | Behavioural | Pivotal Response Treatment (PRT) |
Primary outcome
Change from Baseline on the MacArthur-Bates Communication Development Inventory at 6, 12, and 24 weeks
Time frame: 6, 12 and 24 weeks
Change from Baseline in communication during parent-child and clinician-child interactions at 6, 12, and 24 weeks
Time frame: 6, 12 and 24 weeks
Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks
Time frame: 6, 12 and 24 weeks
Change from Baseline on the Clinical Global Impression Scale at 6, 12, and 24 weeks
Time frame: 6, 12, and 24 weeks
3 secondary outcomes
Change from Baseline on the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at 6, 12, and 24 weeks
Time frame: 6, 12 and 24 weeks
Change from Baseline on the Parenting Stress Index (PSI) at 6, 12, and 24 weeks
Time frame: 6, 12, and 24 weeks
Change from Baseline on the Family Empowerment Scale (FES) at 6, 12, and 24 weeks
Time frame: 6, 12, and 24 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 12 Jan 2021.
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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.
Antonio Y. Hardan, M.D. principal investigator
Stanford 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 Pivotal Response Treatment (PRT) in people with Intellectual Disabilities and Speech Delay, run by Stanford 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 0 inclusion and 2 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 12 Jan 2021. 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?
Change from Baseline on the MacArthur-Bates Communication Development Inventory at 6, 12, and 24 weeks (time frame: 6, 12 and 24 weeks). The study lists 4 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 12 Jan 2021.