Treatment of Disruptive Behaviors in Fragile X Syndrome
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|ClinicalTrials.gov Identifier: NCT03510156|
Recruitment Status : Unknown
Verified May 2019 by Scott Hall, Stanford University.
Recruitment status was: Recruiting
First Posted : April 27, 2018
Last Update Posted : May 9, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Behavioral: Behavior analytic treatment
|No Intervention: Observation|
- 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)
- 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)
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
|Contact: Katerina Monlux, MAemail@example.com|
|United States, California|
|Department of Psychiatry and Behavioral Sciences||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Scott Hall, PhD 650-498-4799 firstname.lastname@example.org|
|Principal Investigator:||Scott S Hall, PhD||Stanford University|