Treatment of Disruptive Behaviors in Fragile X Syndrome

Fragile X Syndrome Clinical Trial

Official title:

Treatment of Disruptive Behaviors in Fragile X Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03510156
• Other study ID #: 36394
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: March 2022

Study information

• Verified date: May 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 3 Years to 10 Years

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

Related Conditions & MeSH terms

• Disruptive Behavior
• Fragile X Syndrome
• Problem Behavior
• Syndrome

Intervention

Behavioral:
• Behavior analytic treatment
Function-based treatment

Locations

Country	Name	City	State
United States	Department of Psychiatry and Behavioral Sciences	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	The John Merck Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline level of problem behavior at 4, 8, 12 and 16 weeks	Aberrant Behavior Checklist - Community (ABC-C)	0, 4, 8, 12, 16 weeks
Secondary	Change from baseline level of treatment acceptability at 4, 8, 12 and 16 weeks	Treatment Acceptability Rating Form - Revised (TARF-R)	0, 4, 8, 12, 16 weeks