PISTACHIO (Preemption Of Disruptive Behavior In Children) Real-Time Monitoring Of Sleep And Behavior Of Children 3-7-Year-Old Receiving Parent Child Interaction Therapy Augmented With Artificial Intelligence Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Frequency of Garmin use
研究概览
简要总结
The purpose of this study is to develop an innovative wearable tracking protocol that will use Artificial Intelligence (AI) technology to monitor sleep and behavior of 3-7 year old children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 3 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children:
- •Outpatients or Inpatients.
- •Any gender, race or ethnicity.
- •Able to provide developmentally appropriate informed assent, and legal guardians able to provide informed consent .
- •EBP Severity rated above the clinically significant range (≥120; T-score ≥ 60) (Eyberg Child Behavior Inventory- ECBI; Eyberg & Pincus, 1999).
- •Need for more intensive behavioral treatments such as ER visit for behavioral dyscontrol or hospitalization will not be exclusionary or exit criteria.
- •Families approached for participation will be asked to commit to complete the treatment.
- •At least one primary caregiver and the identified child will have to be able to speak and understand English.
排除标准
- •Children:
- •Formal diagnosis of Severe Intellectual disability, Autistic Spectrum Disorder Level 3, or a psychotic disorder for the child.
- •Parents not consenting to the study.
- •Parents or child is not able to adhere to the study protocol.
- •A Child who is reasonable expected to be unable to tolerate wearing the Garmin device for at least 70% of the time during the day and night 70% of the days during the treatment (12 weeks). This is based on the principal investigator's discretion.
- •Unable to speak and understand English.
- •Refusal or withdrawal of consent, inability, or unwillingness to adhere to study procedures.
- •Children in foster care.
- •Inclusion Criteria - Adults:
- •Agree to wear Garmin watch.
- •Any gender, race, ethnicity.
- •Able to provide informed consent.
- •Exclusion Criteria - Adults:
- •Unable to speak and understand English.
- •Refusal or withdrawal of consent, inability, or unwillingness to adhere to study procedures.
研究组 & 干预措施
AI Parent Child Interaction Therapy
Subjects enrolled in Parent Child Interaction Therapy (PCIT) will wear a Garmin smartwatch that will provided targeted messages during tantrums picked up by the Garmin devices that will instruct them on how to deescalate their child.
干预措施: Garmin (Device)
Sham Biometric - Parent Child Interaction Therapy
Subjects enrolled in Parent Child Interaction Therapy will wear Garmin smartwatch and will receive only random messages throughout the day with various relaxation strategies such as reminders to practice deep breathing with their child.
干预措施: Garmin (Device)
结局指标
主要结局
Frequency of Garmin use
时间窗: 12 weeks
Number of days participants wear the Garmin smartwatch
次要结局
- Eyberg Child Behavior Inventory(12 weeks)
- Pediatric Sleep Questionnaire(12 weeks)
研究者
Paul E. Croarkin
Principal Investigator
Mayo Clinic