Fragile X SyndromePhase 1/2NCT02616796
Effects of Social Gaze Training on Brain and Behavior in Fragile X Syndrome
A Phase 1/2 study testing Social gaze training in people with Fragile X Syndrome and Intellectual Disability, run by Stanford University at 1 site in United States.
Trial summary
The purpose of the study is to evaluate a 2-3 day treatment probe targeted to improving social gaze behavior in children with fragile X syndrome (FXS). The investigators will use the principles of Applied Behavior Analysis (ABA) to shape appropriate social skills. Read more about this study
- Who is it for?
- Ages 8 to 18 years, men only
- Conditions the study is for
- Fragile X Syndrome, Intellectual Disability
- What is being tested?
- Social gaze training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Dec 2020
- Phase
- Phase 1/2
- 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 8 to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Boys diagnosed with fragile X syndrome
- Boys with intellectual disability who do not have FXS or other known genetic disorder associated with intellectual disability
- Age 8 to 18 years inclusive
- Ability to travel to Stanford
- Vineland Adaptive Behavior Scales standard score between 50 and 75 points
Who cannot join
- Sensory impairments, or any other serious medical or neurological condition that affects growth or development (e.g., seizure disorder, diabetes, congenital heart disease).
- Materials in body that would preclude an MRI scan (e.g., dental braces).
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
The purpose of the study is to evaluate a 2-3 day treatment probe targeted to improving social gaze behavior in children with fragile X syndrome (FXS). The investigators will use the principles of Applied Behavior Analysis (ABA) to shape appropriate social skills. Importantly, the investigators propose to examine the effects of this treatment probe on brain and behavior.
- Conditions
- Fragile X Syndrome, Intellectual Disability
- Being tested
- Social gaze training
- Medical subject headings
- Fragile X Syndrome, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social gaze trainingBehavioural
Appropriate social gaze behavior will be shaped using the principles of Applied Behavior Analysis.
| Study group | Role | What they receive |
|---|---|---|
| Social gaze training | Experimental | Appropriate social gaze behavior will be reinforced using the principles of Applied Behavior Analysis. Receives: Behavioral: Social gaze training |
| No Training | No intervention | Appropriate social gaze behavior will not be reinforced. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of social gaze aversion recorded during the social challenge
Measured: 3 days
Heart rate recorded during the social challenge
Measured: 3 days
Total t-score on the Social Responsiveness Scale (SRS)
Measured: 4 weeks
Secondary outcomes (2)
Verbal responses and pauses in conversation observed during the social challenge
Measured: 3 days
Fractional Amplitude of Low Frequency fluctuations (fALLF) measured in the insular cortex
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fragile X SyndromeStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Hall, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616796
- Sponsor's protocol ID
- 31648
- Status last verified
- Nov 2023
- First submitted
- 25 Nov 2015
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gannon CE, Britton TC, Wilkinson EH, Hall SS. Improving social gaze behavior in fragile X syndrome using a behavioral skills training approach: a proof of concept study. J Neurodev Disord. 2018 Aug 28;10(1):25. doi: 10.1186/s11689-018-9243-z.
PubMed 30153790
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Social Gaze Training on Brain and Behavior in Fragile X Syndrome
- ClinicalTrials.gov ID
- NCT02616796
- Acronym / sponsor ID
- 31648
- Conditions
- Fragile X Syndrome, Intellectual Disability
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 30 Nov 2015 (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 the study is to evaluate a 2-3 day treatment probe targeted to improving social gaze behavior in children with fragile X syndrome (FXS). The investigators will use the principles of Applied Behavior Analysis (ABA) to shape appropriate social skills. Importantly, the investigators propose to examine the effects of this treatment probe on brain and behavior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social gaze training | Experimental | Behavioral: Social gaze trainingAppropriate social gaze behavior will be reinforced using the principles of Applied Behavior Analysis. |
| No Training | No intervention | –Appropriate social gaze behavior will not be reinforced. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Boys diagnosed with fragile X syndrome
- Boys with intellectual disability who do not have FXS or other known genetic disorder associated with intellectual disability
- Age 8 to 18 years inclusive
- Ability to travel to Stanford
- Vineland Adaptive Behavior Scales standard score between 50 and 75 points
Key exclusion criteria (2 listed)
- Sensory impairments, or any other serious medical or neurological condition that affects growth or development (e.g., seizure disorder, diabetes, congenital heart disease).
- Materials in body that would preclude an MRI scan (e.g., dental braces).
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 |
|---|---|---|
| Social gaze trainingAppropriate social gaze behavior will be shaped using the principles of Applied Behavior Analysis. | Behavioural | Social gaze training |
Primary outcome
Percentage of social gaze aversion recorded during the social challenge
Time frame: 3 days
Heart rate recorded during the social challenge
Time frame: 3 days
Total t-score on the Social Responsiveness Scale (SRS)
Time frame: 4 weeks
2 secondary outcomes
Verbal responses and pauses in conversation observed during the social challenge
Time frame: 3 days
Fractional Amplitude of Low Frequency fluctuations (fALLF) measured in the insular cortex
Time frame: 3 days
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 9 Nov 2023.
- Derived from this study: PubMed 30153790Gannon CE, Britton TC, Wilkinson EH, Hall SS. Improving social gaze behavior in fragile X syndrome using a behavioral skills training approach: a proof of concept study. J Neurodev Disord. 2018 Aug 28;10(1):25. doi: 10.1186/s11689-018-9243-z.
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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 Phase 1/2 study testing Social gaze training in people with Fragile X Syndrome and Intellectual Disability, 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 5 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 9 Nov 2023. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Percentage of social gaze aversion recorded during the social challenge (time frame: 3 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02616796, which also lists 1 linked publication.
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 Nov 2023.