跳至主要内容
临床试验/NCT04732806
NCT04732806已完成不适用

A Mightier Healthcare System: Introducing a Game-based Pediatric Mental Health Intervention Into Payor-sponsored Care to Evaluate Financial and Clinical Outcomes

Neuromotion Labs1 个研究点 分布在 1 个国家目标入组 183 人开始时间: 2021年3月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
183
试验地点
1
主要终点
Behavioral healthcare utilization cost

研究概览

简要总结

Access to effective pediatric mental health treatment is a major public health concern in the United States as paucity of pediatric providers leading to long wait times, financial burden, and stigma pose significant barriers to treatment. Digital mental health promises to remedy many chronic problems faced in providing timely and accessible mental health interventions to children. With that in mind, the investigators and Neuromotion Inc. created Mightier, an app-based heart rate biofeedback videogame platform designed to teach and facilitate practice of emotional regulation skills. The technology behind Mightier is backed by three trials showing clinical efficacy and since commercial launch 75% of families who have engaged with the product report improvement. However, Neuromotion's core mission remains increasing access to care, and the direct-to-consumer distribution of digital health also faces access challenges. The investigators propose that access to effective digital mental health interventions can be increased by meeting families where they already know to seek care: the traditional healthcare system. The investigators have partnered with a nationwide behavioral health insurance provider to pilot the integration of Mightier with traditional healthcare. Families will be recruited via direct outreach, social media, or healthcare provider referral. Participating children will be randomized into Mightier or treatment as usual control groups for 6 months. Behavioral healthcare utilization will be observed for 12 months. Through this work the investigators will demonstrate the value of Mightier to various stakeholders via decreased long-term healthcare utilization, confirm that Mightier use results in decreased symptoms of emotional dysregulation, irritability, and parent stress, and explore relationships among Mightier use, healthcare utilization, and symptoms. Ultimately this work will pave the way forward for large scale integration of digital healthcare and more traditional healthcare avenues while simultaneously increasing Mightier's ability to reach children in need.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Insurance provided by Magellan Healthcare OR participant is covered by insurance in Massachusetts and has access to Explanation of Benefits information via online portal
  • Has made a behavioral health claim in the past year
  • MOAS score of greater than or equal to 2
  • Evidence of ADHD, ODD, CD, DMDD, IED, or ASD by MINI-KID
  • Parent or guardian is fluent in English
  • WiFi at home (for Mightier tablet connection)
  • Access to a computer or tablet in the home

排除标准

  • IQ < 70 (by medical record or clinician judgment)
  • Extremely limited verbal capacity
  • Change in medication or medication dosage in the past month or planned change in medication or medication dosage in the next month
  • Active suicidal ideation
  • History of suicide attempt and current depression
  • Physical limitations that preclude the use of Mightier
  • Sensory sensitivities that would preclude wearing an arm (or leg) heart rate monitor
  • Evidence of psychosis, mania, alcohol use disorder, substance use disorder, or PTSD by MINI-Kid
  • Ongoing or within the month prior to baseline visit placement in foster care or residential facility

研究组 & 干预措施

Treatment as usual

No Intervention

Intervention

Experimental

Six months of ad lib Mightier play in home

干预措施: Mightier video games (Behavioral)

结局指标

主要结局

Behavioral healthcare utilization cost

时间窗: 12 Months

Dollars spent on behavioral healthcare over the study period.

Change in Modified Overt Aggression Scale (MOAS) from baseline to 3 Months

时间窗: Baseline, 3 months

The MOAS is a 5-point parent rated scale that rates the severity of four types of aggression: verbal, against property, against self (auto-aggression), and physical towards others. Scores range from 0-100 with lower scores representing less aggression (better outcome).

次要结局

  • Change in Parent Stress Index - Short Form (PSI-SF) from baseline to 3 Months(Baseline, 3 months)
  • Clinical Global Impression - Improvement, Irritability/Anger (CGI-I Irritability/Anger)(3 months)
  • Clinical Global Impression - Improvement, Aggression (CGI-I Aggression)(3 months)
  • Clinical Global Impression - Improvement, Oppositional/Defiant Behavior (CGI-I Oppositional/Defiant Behavior)(3 months)
  • Change in Disruptive Behavior Disorder Rating Scale (DBDRS) - Oppositional/Defiant Factor Score from baseline to 3 Months(Baseline, 3 months)
  • Change in Affective Reactivity Index - Parent (ARI-P) from baseline to 3 Months(Baseline, 3 months)
  • Clinical Global Impression - Improvement, Disruptive Behavior (CGI-I Disruptive Behavior)(3 months)
  • Change in Parent Confidence and Resources from baseline to 3 Months(Baseline, 3 months)
  • Change in NIH-Emotion Toolbox from baseline to 3 Months(Baseline, 3 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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