Initial Efficacy Study of Supporting Play, Exploration, & Early Development Intervention (SPEEDI) - Phase 1 Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Reaching (Toy Contact Duration)
研究概览
简要总结
The primary aims of this randomized controlled trial are to evaluate efficacy potential of SPEEDI at enhancing reaching and play based problem solving compared to infants receiving usual care.
详细描述
The primary aims of this randomized controlled trial are to evaluate efficacy potential of SPEEDI at enhancing reaching and play based problem solving compared to infants receiving usual care. The secondary aim is to assess the efficacy potential of SPEEDI to impact motor and cognitive development as assessed using commonly used clinical outcome measures. The exploratory aims are to assess the impact of SPEEDI on parent child interactions and feeding skills. The findings will provide crucial initial efficacy estimates to be used in a larger definitive clinical trial of SPEEDI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 18 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •born extremely preterm (˂29 weeks of gestation) OR 10 born preterm and diagnosed with a neonatal brain injury including intraventricular hemorrhage grade 3 or 4, periventricular white matter injury, or hydrocephalus requiring a shunt.
- •Medically stable by 40 weeks of gestation, including being off ventilator support
- •Live within 50 minutes of the hospital.
- •English Speaking mother
- •Mother willing and able to participate in the study with the infant subject
排除标准
- •Genetic syndromes or musculoskeletal deformities
研究组 & 干预措施
Usual Care Group
This group of subjects will receive usual care provided in the medial system and community.
SPEEDI Intervention
This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.
干预措施: SPEEDI Intervention (Behavioral)
结局指标
主要结局
Reaching (Toy Contact Duration)
时间窗: 1 month post intervention
Duration the infant is in contact with the target is used to quantify changes in reaching.
Early Problem Solving Indicator (EPSI)
时间窗: End of intervention, 1 and 3 months post intervention
Problem-solving behaviors were assessed using the Early Problem Solving Indicator (EPSI). The EPSI is the cognitive subtest of the Individual Growth and Development Indicators designed to measure infant and toddler play-based problem-solving through 36 months of age. It defines problem-solving as consisting of visual exploration, object manipulation and memory. The infant was video-recorded interacting with 3 standard toys: pop-up animals toy, 6 seriated, plastic cups, and a gum ball machine with 5 balls. Infants were given each toy for 2 minutes. The frequency of 4 mutually exclusive behaviors (look, explore, function, solution) were coded using definitions from the EPSI protocol. time. The total number of problem solving behaviors was calculated as a sum of look, explore, function, and solution for each infant at each visit and reported as the total EPSI frequency with a higher frequency reflecting more problem solving behaviors.
次要结局
- Early Feeding Skill Assessment (FES)(Baseline, End phase 1, End of intervention, 1 and 3 months post intervention)
- Parent Child Early Relational Assessment (PCERA)(Baseline, End phase 1, End of intervention, 1 month post intervention)
- Bayley Scales of Infant and Toddler Development (Bayley).(3 month post intervention)
- Test of Infant Motor Performance (TIMP)(Baseline to End of intervention)