A Prospective, Observational Study of Mobile Attentional Bias Modification Training (ABMT) in the Pediatric Multiple Sclerosis (MS) Population
Sponsor study identifier
interventional
37
1 country
1
Study Start
June 12, 2020
Actual (reported)Primary Completion
March 25, 2021
Actual (reported)Study Completion
March 26, 2021
Actual (reported)This study will examine the feasibility of using a mobile ABMT application as a treatment modality in the Pediatric Multiple Sclerosis population. Participants will be asked to undergo one hour-long baseline evaluation, followed by at-home ABMT application sessions. Subjects will complete online REDCap or MyCap surveys weekly and at the end of the study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 26, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 12, 2020
Actual (reported)June 19, 2020
Actual (reported)June 22, 2020
Actual (reported)March 25, 2021
Actual (reported)March 26, 2021
Actual (reported)Proportion of "compliant" participants
Individuals will be categorized as "compliant" if they interact with the mobile ABMT a minimum of 3 times per week for a minimum of three of the four weeks across the study period of 30 days. We will consider reaching 50% of compliant participants to indicate that the intervention is feasible for continued study. Descriptive analyses will be completed to identify any trends in predicting those participants who are most likely to be compliant (ie. age, gender, baseline function).
30 days
Preliminary efficacy composite score
3 months
Patients age 12-24 diagnosed with pediatric-onset Multiple Sclerosis
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
NYU Langone Health
New York, New York, 10016, United States
Leigh Charvet
NYU Langone Health
37 participants (actual enrollment reported by the registry).
First Submitted
June 19, 2020
First Posted
June 22, 2020
Study Start
June 12, 2020
Actual (reported)Primary Completion
Sleep, Physical Activity and Multiple Sclerosis Symptoms in Pediatric Multiple Sclerosis
Contact the study team to confirm eligibility.
March 25, 2021
Actual (reported)Study Completion
March 26, 2021
Actual (reported)Last Updated
March 4, 2022
Record last verified: 2022-03
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: leigh.charvet@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Source: ClinicalTrials.gov.
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