A Prospective, Observational Study of Mobile Attentional Bias Modification Training (ABMT) in the Pediatric Multiple Sclerosis (MS) Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Proportion of "compliant" participants
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Proportion of "compliant" participants
时间窗: 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).
次要结局
- Preliminary efficacy composite score(3 months)