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Treatment of Disruptive Behaviors in Fragile X Syndrome

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ClinicalTrials.gov Identifier: NCT03510156
Recruitment Status : Recruiting
First Posted : April 27, 2018
Last Update Posted : April 27, 2018
Sponsor:
Collaborator:
The John Merck Fund
Information provided by (Responsible Party):
Scott Hall, 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.


Condition or disease Intervention/treatment Phase
Fragile X Syndrome Disruptive Behavior Behavioral: Behavior analytic treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Disruptive Behaviors in Fragile X Syndrome
Actual Study Start Date : July 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Behavioral: Behavior analytic treatment
Function-based treatment

No Intervention: Observation



Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03510156


Contacts
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Contact: Katerina Monlux, MA 650-422-1032 kmonlux@stanford.edu

Locations
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United States, California
Department of Psychiatry and Behavioral Sciences Recruiting
Stanford, California, United States, 94305
Contact: Scott Hall, PhD    650-498-4799    hallss@stanford.edu   
Sponsors and Collaborators
Stanford University
The John Merck Fund
Investigators
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Principal Investigator: Scott S Hall, PhD Stanford University

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Responsible Party: Scott Hall, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03510156     History of Changes
Other Study ID Numbers: 36394
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fragile X Syndrome
Mental Retardation, X-Linked
Genetic Diseases, X-Linked
Syndrome
Problem Behavior
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Behavioral Symptoms