Treatment of Disruptive Behaviors in Fragile X Syndrome | NCT03510156

Studies
Treatment of Disruptive Behaviors in Fragile X Syndrome

NCT03510156

Sponsor

Stanford University

Status

Completed

Last Update Posted

May 4, 2022Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Fragile X Syndrome
Disruptive Behavior

Interventions

Behavior analytic treatment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016Actual

Primary Completion Date

Mar 2022Actual

Completion Date

Mar 2022Actual

First Submitted Date

Apr 17, 2018

First Submission Date that Met QC Criteria

Apr 25, 2018

First Posted Date

Apr 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2022

Last Update Posted Date

May 4, 2022Actual

Name	Class
The John Merck Fund	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Label	Type	Description	Intervention Names
Treatment	Experimental		Behavioral: Behavior analytic treatment
Observation	No Intervention

Name	Type	Description	Arm Group Labels	Other Names
Behavior analytic treatment	Behavioral	Function-based treatment	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Scott S Hall, PhD	Stanford University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Department of Psychiatry and Behavioral Sciences		Stanford	California	94305	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36180840	Derived	Hall SS, Rodriguez AB, Jo B, Pollard JS. Long-term follow-up of telehealth-enabled behavioral treatment for challenging behaviors in boys with fragile X syndrome. J Neurodev Disord. 2022 Sep 30;14(1):53. doi: 10.1186/s11689-022-09463-9.
33218305	Derived	Hall SS, Monlux KD, Rodriguez AB, Jo B, Pollard JS. Telehealth-enabled behavioral treatment for problem behaviors in boys with fragile X syndrome: a randomized controlled trial. J Neurodev Disord. 2020 Nov 20;12(1):31. doi: 10.1186/s11689-020-09331-4.

ID	Term
D005600	Fragile X Syndrome
D000066553	Problem Behavior

ID	Term
D038901	X-Linked Intellectual Disability
D008607	Intellectual Disability
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations