Teaching Math Skills to Individuals With Fragile X Syndrome

NCT ID: NCT01204151

Last Updated: 2019-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2013-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Developmental Disabilities Fragile X Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Math intervention

Group Type EXPERIMENTAL

discrete-trial training

Intervention Type BEHAVIORAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

discrete-trial training

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* (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).

Exclusion Criteria

* 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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

23 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stanford University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Scott Hall

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Scott Hall

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SU-09132010-6849

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cognitive Control and Metacognition Training
NCT06885684 NOT_YET_RECRUITING NA