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OpenTrials
Completed

NCT Number: NCT03510156

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.

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Key information

Conditions

Fragile X Syndrome Behavior Behavioral Symptoms Child Behavior Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disruptive Behavior Genetic Diseases, Inborn Genetic Diseases, X-Linked Heredodegenerative Disorders, Nervous System Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Problem Behavior Sex Chromosome Disorders X-Linked Intellectual Disability

Age range

3 year–10 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry and Behavioral Sciences

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Child has a confirmed diagnosis of FXS (>200 CGG repeats on the FMR1 gene with evidence of aberrant methylation)
  • Child is male, between the ages of 3-10 years old
  • Child is reported to show self-injury, property destruction and/or aggression on at least a daily basis
  • 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
  • The family has a high-speed internet connection at home or lives in an area with 4G network coverage
  • Availability for one-hour daily telemedicine treatment sessions
  • Availability for in-home assessment totaling 8 hours across two consecutive days

Exclusion criteria

  • The child or caregiver has significant sensory impairments (e.g., blindness or deafness)
  • Non-English speaking
  • The child receives Applied Behavior Analysis services in excess of five hours per week
  • The child has a significant neurological condition (e.g., frequent seizures, brain injury, Tourette's syndrome) that would preclude participation
  • The child or caregiver has significant mobility issues
  • The child is currently participating in another research study that would preclude participation in the study

Treatment and study plan

Behavior analytic treatment

Behavioral

Function-based treatment

Primary outcomes

  1. Change from baseline level of problem behavior at 4, 8, 12 and 16 weeks

    Time frame: 0, 4, 8, 12, 16 weeks

    Aberrant Behavior Checklist - Community (ABC-C)

Secondary outcomes

  1. Change from baseline level of treatment acceptability at 4, 8, 12 and 16 weeks

    Time frame: 0, 4, 8, 12, 16 weeks

    Treatment Acceptability Rating Form - Revised (TARF-R)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • The John Merck Fund

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Apr 27, 2018
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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