Trial Search Results

Treatment of Disruptive Behaviors in Fragile X Syndrome

Disruptive behaviors such as self-injury, aggression, and property destruction pose significant health-related issues to children diagnosed with fragile X syndrome (FXS), impacting the child's quality of life and causing significant distress to families.

Access to appropriate treatment for families is severely limited by factors such as cost of care, shortages of qualified treatment providers, and geographic spread of children with FXS across the country. To address these potential issues, the effectiveness of administering a standardized function-based behavioral treatment for problem behaviors in FXS will be evaluated using telemedicine. The proposed study intervention therefore offers a tremendous step forward in clinical research both in the field of FXS and in the field of developmental disabilities more broadly, and thus will have a significant impact on public health.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: The John Merck Fund

Stanford Investigator(s):

Intervention(s):

  • Behavioral: Behavior analytic treatment

Phase:

N/A

Eligibility


Inclusion Criteria:

   1. Child has a confirmed diagnosis of FXS (>200 CGG repeats on the FMR1 gene with
   evidence of aberrant methylation)

   2. Child is male, between the ages of 3-10 years old

   3. Child is reported to show self-injury, property destruction and/or aggression on at
   least a daily basis

   4. The caregiver agrees to keep any therapies that the child receives (i.e., medications
   or other treatments) as stable as possible throughout involvement in the study

   5. The family has a high-speed internet connection at home or lives in an area with 4G
   network coverage

   6. Availability for one-hour daily telemedicine treatment sessions

   7. Availability for in-home assessment totaling 8 hours across two consecutive days

Exclusion Criteria:

   1. The child or caregiver has significant sensory impairments (e.g., blindness or
   deafness)

   2. Non-English speaking

   3. The child receives Applied Behavior Analysis services in excess of five hours per week

   4. The child has a significant neurological condition (e.g., frequent seizures, brain
   injury, Tourette's syndrome) that would preclude participation

   5. The child or caregiver has significant mobility issues

   6. The child is currently participating in another research study that would preclude
   participation in the study

Ages Eligible for Study

3 Years - 10 Years

Genders Eligible for Study

Male

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Katerina Monlux, MA
650-422-1032
Recruiting