Treatment of Disruptive Behaviors in Fragile X Syndrome

Not Applicable

Completed

• Conditions: Disruptive Behavior; Fragile X Syndrome
• Interventions: Behavioral: Behavior analytic treatment

• Registration Number: NCT03510156
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2018-04-17
• Study First Submitted QC: 2018-04-25
• Study First Posted: 2018-04-27
• Primary Completion: 2022-03
• Study Completion: 2022-03
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Behavior analytic treatment	-

Primary Outcome Measures

Name	Time	Method
Change from baseline level of problem behavior at 4, 8, 12 and 16 weeks	0, 4, 8, 12, 16 weeks	Aberrant Behavior Checklist - Community (ABC-C)

Secondary Outcome Measures

Name	Time	Method
Change from baseline level of treatment acceptability at 4, 8, 12 and 16 weeks	0, 4, 8, 12, 16 weeks	Treatment Acceptability Rating Form - Revised (TARF-R)

Trial Locations

Locations (1)

Department of Psychiatry and Behavioral Sciences; 🇺🇸 Stanford, California, United States