Healing Tiny Minds: Rural Recovery Through Virtual and Lived Experience Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Parent Satisfaction Questionnaire
研究概览
简要总结
The goal of this behavioral-interventional study is to learn if the Abecedarian Approach implemented virtually for children ages 0-5 with a history of Hypoxic Ischaemic Encephalopathy (HIE) and/or premature birth produces the same effects as when administered at in-person facilities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IPNH-NDCP patients, including:
- •Term-born children diagnosed during the neonatal period with hypoxic-ischemic encephalopathy, or
- •premature children (born at less than 28 weeks gestational age).
- •Parent or legal guardian will also be enrolled as a participant
- •Parents must be English-speaking (able to provide consent and complete questionnaires).
排除标准
- •Not suitable for study participation due to other reasons at the discretion of the investigator.
- •Infants with chromosomal abnormalities, genetic syndromes (for example, such as Down Syndrome or Trisomy18) and major congenital malformations will be excluded.
- •Infants with vision impairment will also be excluded from the study, as our study procedures do require intact vision to be able to complete.
- •For parents or legal guardians, there are no exclusion criteria.
研究组 & 干预措施
Standard of Care Provided
In the No Intervention condition, at-risk children will receive the current standard of care, and no intervention.
Virtual Abecedarian Approach Intervention
In the Virtual Abecedarian Approach Intervention, children will partake in the Abecedarian Approach Intervention through a virtual format.
干预措施: Abecedarian Approach (Behavioral)
Feasibility Group
Participants will be in fewer sessions in order to assess whether the intervention is accepted by the parents.
干预措施: Abecedarian Approach (Behavioral)
结局指标
主要结局
Parent Satisfaction Questionnaire
时间窗: Assessed at end of treatment (up to 60 months)
Questionnaire measuring parent satisfaction with the intervention and effects given at the end of the virtual program. Responses as measured by answering either strongly agree, agree, disagree or strongly disagree. Responses will be measured at the end of the intervention at 60 months and reported as participant counts.
Number of Sessions Attended
时间窗: Assessed biweekly from enrollment to end of treatment (up to 260 weeks)
We will be taking attendance of sessions to measure parent compliance with the virtual program. Attendance will be taken for each live session (every other week) for the entire period of enrollment (260 weeks).
次要结局
- Bayley Assessment(Data collected at 12, 24, 36, 48, and 60 month time points)
- Behavior Reporting Inventory of Executive Function - Preschool Version (BRIEF-P)(Data collected at the 24, 36, 48, and 60 month time points)
- Pediatric Quality of Life Inventory (PedsQL)(Data collected at baseline, 24, 36, 48 and 60 month time points)
- Early Executive Functions Questionnaire (EEFQ)(Data collected at baseline, 12, and 24 month time points)
- NIH Baby/Infant and NIH Pediatric Toolbox(Data collected at 12, 24, 36, 48, and 60-month time points)
- Infant Attention Task (IAT) measured in seconds(baseline and 12 months)