Mobile Attentional Bias Modification Training in Pediatric MS

A Prospective, Observational Study of Mobile Attentional Bias Modification Training (ABMT) in the Pediatric Multiple Sclerosis (MS) Population

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Multiple Sclerosis
• Intervention / Treatment: Behavioral: ABMT mobile application

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 12-24 years
• 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:

• Previous report of an IQ < 70
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment Group; Patients age 12-24 diagnosed with pediatric-onset Multiple Sclerosis

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preliminary efficacy composite score	Investigators convert performance at baseline and study end across study measures SCARED P/C,CDI-II, MASC-2, BDI-II, BAI, and PANAS to scaled age normative scores. Differences in scaled scores, indicating change following intervention, will be calculated for each compliant participant (defined as above) and averaged for group metrics. Descriptive analyses will be completed to identify any trends in predicting those participants who are most likely to have improvement in anxiety and mood at study end (ie., age, gender, baseline function) as well as corresponding degree of use of the mobile ABMT with magnitude of benefit.	3 months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Leigh Charvet, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2020
• Primary Completion (Actual): March 25, 2021
• Study Completion (Actual): March 26, 2021

Study Registration Dates

• First Submitted: June 19, 2020
• First Submitted That Met QC Criteria: June 19, 2020
• First Posted (Actual): June 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 19-00810

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: Requests should be directed to leigh.charvet@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No