Mobile Attentional Bias Modification Training in Pediatric MS

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT04441229
• Collaborator: (none)
• Enrollment: 37
• Location: 1
• Arm: 1
• Actual Duration (Months): 9.4
• Patients Per Site Per Month: 3.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Multiple Sclerosis	Behavioral: ABMT mobile application	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Observational Study of Mobile Attentional Bias Modification Training (ABMT) in the Pediatric Multiple Sclerosis (MS) Population
• Actual Study Start Date: Jun 12, 2020
• Actual Primary Completion Date: Mar 25, 2021
• Actual Study Completion Date: Mar 26, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Proportion of "compliant" participants [30 days]

   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).

Secondary Outcome Measures

1. Preliminary efficacy composite score [3 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 24 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Health	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Leigh Charvet, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT04441229
• Other Study ID Numbers: 19-00810
• First Posted: Jun 22, 2020
• Last Update Posted: Mar 4, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Multiple Sclerosis; Sclerosis

Study Results

No Results Posted as of Mar 4, 2022