Mobile Attentional Bias Modification Training in Pediatric MS
NCT ID: NCT04441229
Last Updated: 2022-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2020-06-12
2021-03-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Group
Patients age 12-24 diagnosed with pediatric-onset Multiple Sclerosis
ABMT mobile application
After consent/assent, participants will complete 1 hour-long, in-person or remote, baseline study visit at the Multiple Sclerosis Comprehensive Care Center. During this visit, participants will complete baseline study surveys and a brief computerized attention bias assessment and be trained on the use of the ABMT mobile application. Participants will then complete at-home game play 4 days a week, for 30 days, using an iOS mobile device, approximately 10-15 minutes each day. Subjects will complete weekly online study surveys via REDCap or MyCap (Mobile REDCap Application). At the conclusion of participation, participants will complete online end of study surveys via REDCap or MyCap.
Parents of participants will complete surveys at the baseline visit, followed by online surveys at Week 2 and at the end of study. For participants who are 18 years old or older, parental participation will not be required.
Interventions
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ABMT mobile application
After consent/assent, participants will complete 1 hour-long, in-person or remote, baseline study visit at the Multiple Sclerosis Comprehensive Care Center. During this visit, participants will complete baseline study surveys and a brief computerized attention bias assessment and be trained on the use of the ABMT mobile application. Participants will then complete at-home game play 4 days a week, for 30 days, using an iOS mobile device, approximately 10-15 minutes each day. Subjects will complete weekly online study surveys via REDCap or MyCap (Mobile REDCap Application). At the conclusion of participation, participants will complete online end of study surveys via REDCap or MyCap.
Parents of participants will complete surveys at the baseline visit, followed by online surveys at Week 2 and at the end of study. For participants who are 18 years old or older, parental participation will not be required.
Eligibility Criteria
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Inclusion Criteria
* Confirmed Diagnosis of Multiple Sclerosis with onset \< 17 years and 11 months (defined by the 2013 International Pediatric MS Study Group (IPMSSG) criteria (Krupp, Tardieu, Amato, Banwell, Chitnis, Dale, Ghezzi, Hintzen, Kornberg, Pohl, Rostasy, Tenembaum, Wassmer, \& Sclerosis, 2013) and the 2010 McDonald criteria (Polman et al., 2011).)
* Followed at NYU Multiple Sclerosis Comprehensive Care Center
* Access to a mobile device with iOS (devices will be provided to subjects if this criteria is not met, see section 4.4)
* Active or concurrently enrolled in the ongoing US Network of Pediatric MS Centers Study Consortium
Exclusion Criteria
* Wide-Range Achievement Test-Fourth Edition (Wilkerson, 2006) Reading Subtest standard score \<85
* Non-English speaking, learned English in the past three years, or learned English after the age of 12 years
* Not willing to comply with all study procedures
* Insufficient visual and motor ability to operate the intervention and assessments
12 Years
24 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Leigh Charvet
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Other Identifiers
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19-00810
Identifier Type: -
Identifier Source: org_study_id
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