Back to resultsMobile Attentional Bias Modification Training in Pediatric MS
Primary Purpose
Pediatric Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ABMT mobile application
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Multiple Sclerosis
Eligibility Criteria
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
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Group
Arm Description
Patients age 12-24 diagnosed with pediatric-onset Multiple Sclerosis
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04441229
Brief Title
Mobile Attentional Bias Modification Training in Pediatric MS
Official Title
A Prospective, Observational Study of Mobile Attentional Bias Modification Training (ABMT) in the Pediatric Multiple Sclerosis (MS) Population
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 12, 2020 (Actual)
Primary Completion Date
March 25, 2021 (Actual)
Study Completion Date
March 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Patients age 12-24 diagnosed with pediatric-onset Multiple Sclerosis
Intervention Type
Behavioral
Intervention Name(s)
ABMT mobile application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of "compliant" participants
Description
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).
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Preliminary efficacy composite score
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leigh Charvet
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Mobile Attentional Bias Modification Training in Pediatric MS
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