Mobile Attentional Bias Modification Training in Pediatric MS

Pediatric Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04441229
• Other study ID #: 19-00810
• Status: Completed
• Phase: N/A
• Start date: June 12, 2020
• Est. completion date: March 26, 2021

Study information

• Verified date: March 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: March 26, 2021
• Est. primary completion date: March 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Pediatric Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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