Developmental DisabilitiesNCT01204151
Teaching Math Skills to Individuals With Fragile X Syndrome
A study testing discrete-trial training in people with Developmental Disabilities and Fragile X Syndrome, run by Stanford University at 1 site in United States.
Trial summary
Children with FXS are predisposed to manifesting a particular profile of intellectual strengths and weaknesses, including specific deficits in math, visual-spatial skills, executive functioning, and social skills. Until now, intensive behavioral interventions have not been targeted to syndrome-specific weaknesses. Read more about this study
- Who is it for?
- Ages 10 to 23 years
- Conditions the study is for
- Developmental Disabilities, Fragile X Syndrome
- What is being tested?
- discrete-trial training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jul 2013
- 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 10 to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- (a) 10 to 23 years of age (this age range was chosen to maximize the probability that subjects will cooperate with the imaging procedures as well as benefit from the interventions),
- (b) in good physical health,
- (c) able to participate in the imaging component of the project,
- (d) IQ between 50 and 80. We have found that individuals with IQ's less than 50 points are generally unable to comply with the scanning procedures.
- (e) diagnosis of FXS (for FXS group) and non-specific developmental disorder (for control group).
Who cannot join
- contraindications for MRI (e.g., pacemaker, braces),
- the presence of neurological or sensory problems not associated with the conditions of interest (e.g., head trauma, blindness), or inability to discontinue psychotropic medication for 4 weeks prior to the scan.
- Additional exclusion criteria for the control group include the presence of any known identifiable syndrome (e.g., fragile X syndrome, Down syndrome, Prader-Willi syndrome, Turner syndrome, PKU, fetal alcohol syndrome, Williams syndrome).
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Evaluating a Brief Intensive Intervention for Individuals With Fragile X Syndrome
Children with FXS are predisposed to manifesting a particular profile of intellectual strengths and weaknesses, including specific deficits in math, visual-spatial skills, executive functioning, and social skills. Until now, intensive behavioral interventions have not been targeted to syndrome-specific weaknesses. In the present study we will develop and evaluate behavioral strategies to aid skill acquisition in children with FXS.
Read the detailed description
There are no experimental data of skill acquisition using matching-to-sample techniques (or any other specific cognitive intervention) conducted with individuals with FXS. Further, no studies have been conducted to examine the possible underlying or mediating brain processes involved during matching-to-sample skill acquisition in children with FXS or any other neurodevelopmental disorder.
Previous pilot data have indicated that the computerized match-to-sample procedure, even when conducted in time-limited sessions, may significantly help individuals with FXS learn new skills. We plan to utilize brain imaging methodology to compare functional connectivity networks for those who pass and those who fail the equivalence test. 30 subjects with FXS and 30 control subjects with idiopathic developmental disability will be enrolled in the study. All subjects will be enrolled at Stanford.
- Conditions
- Developmental Disabilities, Fragile X Syndrome
- Being tested
- discrete-trial training
- Medical subject headings
- Developmental Disabilities, Fragile X Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
discrete-trial trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Math intervention | Experimental | Not described Receives: Behavioral: discrete-trial training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent correct
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startSep 2008
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Hall, Stanford University
- Investigators
- Scott Hall, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204151
- Sponsor's protocol ID
- SU-09132010-6849
- Status last verified
- May 2019
- First submitted
- 15 Sep 2010
- Last updated
- 9 May 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Brief Intensive Intervention for Individuals With Fragile X Syndrome
- ClinicalTrials.gov ID
- NCT01204151
- Acronym / sponsor ID
- SU-09132010-6849
- Conditions
- Developmental Disabilities, Fragile X Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 17 Sep 2010 (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.
Children with FXS are predisposed to manifesting a particular profile of intellectual strengths and weaknesses, including specific deficits in math, visual-spatial skills, executive functioning, and social skills. Until now, intensive behavioral interventions have not been targeted to syndrome-specific weaknesses. In the present study we will develop and evaluate behavioral strategies to aid skill acquisition in children with FXS.
Detailed description
There are no experimental data of skill acquisition using matching-to-sample techniques (or any other specific cognitive intervention) conducted with individuals with FXS. Further, no studies have been conducted to examine the possible underlying or mediating brain processes involved during matching-to-sample skill acquisition in children with FXS or any other neurodevelopmental disorder.
Previous pilot data have indicated that the computerized match-to-sample procedure, even when conducted in time-limited sessions, may significantly help individuals with FXS learn new skills. We plan to utilize brain imaging methodology to compare functional connectivity networks for those who pass and those who fail the equivalence test. 30 subjects with FXS and 30 control subjects with idiopathic developmental disability will be enrolled in the study. All subjects will be enrolled at Stanford.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Math intervention | Experimental | Behavioral: discrete-trial training |
Who may qualify
- Ages
- 10 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- (a) 10 to 23 years of age (this age range was chosen to maximize the probability that subjects will cooperate with the imaging procedures as well as benefit from the interventions),
- (b) in good physical health,
- (c) able to participate in the imaging component of the project,
- (d) IQ between 50 and 80. We have found that individuals with IQ's less than 50 points are generally unable to comply with the scanning procedures.
- (e) diagnosis of FXS (for FXS group) and non-specific developmental disorder (for control group).
Key exclusion criteria (3 listed)
- contraindications for MRI (e.g., pacemaker, braces),
- the presence of neurological or sensory problems not associated with the conditions of interest (e.g., head trauma, blindness), or inability to discontinue psychotropic medication for 4 weeks prior to the scan.
- Additional exclusion criteria for the control group include the presence of any known identifiable syndrome (e.g., fragile X syndrome, Down syndrome, Prader-Willi syndrome, Turner syndrome, PKU, fetal alcohol syndrome, Williams syndrome).
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 |
|---|---|---|
| discrete-trial training | Behavioural | Math intervention |
Primary outcome
Percent correct
Time frame: 2 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 May 2019.
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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.
Scott Hall 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 discrete-trial training in people with Developmental Disabilities and Fragile X Syndrome, 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 3 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 May 2019. 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?
Percent correct (time frame: 2 days). 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 May 2019.