Mobile Attentional Bias Modification Training in Pediatric MS

Not Applicable

Completed

• Conditions: Pediatric Multiple Sclerosis
• Interventions: Behavioral: ABMT mobile application

• Registration Number: NCT04441229
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2020-06-12
• Study First Submitted: 2020-06-19
• Study First Submitted QC: 2020-06-19
• Study First Posted: 2020-06-22
• Primary Completion: 2021-03-25
• Study Completion: 2021-03-26
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	ABMT mobile application	Patients age 12-24 diagnosed with pediatric-onset Multiple Sclerosis

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States