A Feasibility Study of the Attention Control Training (ACT) Intervention Among Very Preterm (VP) Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Recruitment and Retention
研究概览
简要总结
Infants' attention control, defined as the ability to select what to pay attention to, is a fundamental building block for developing learning abilities and behaviour self-regulation. Infants born before term (<37 weeks gestation) display delays in attention control, and these delays cause cascade effects that include learning difficulties and behaviour problems. Infants born before 32 weeks of gestation, known as very preterm (VP), are particularly at risk of persistent difficulties in attention.
A ground-breaking early intervention, the Attention Control Training (ACT), targets infants' attention control. The novelty of the ACT lies in engaging young infants in "brain-training" using a computer interface, which tracks infants' gaze direction and presents training visual stimuli appropriate to the infants' ability level. Results demonstrate ACT improves attention of typically developing infants, contributing to improvements in other cognitive abilities (e.g. memory), but ACT has not been tested in clinical populations such as VP infants.
The investigators are running a feasibility study of the ACT intervention amongst VP infants aged 1 year (corrected age for prematurity). This feasibility study is necessary in order to adapt the ACT material and presentation to VP infants, and in particular to investigate the acceptability of a Randomised Trial and its training schedule by parents of VP infants.
The proposed study will allow the investigators to identify solutions to problems, ensuring the ACT material and delivery are customised for VP infants.
详细描述
The aims of this project are to:
- Investigate VP infants' engagement with the ACT procedure;
- Assess the quality of data collected during the training and assessments used, and compare them to similar data obtained from typically developing infants who completed studies conducted by collaborators.
- Investigate retention into the programme.
- Investigate infants' performance in outcome measures and assess trends indicating differences in performance between treated and controls.
To allow for a fair test of the ACT, infants will be randomly assigned to receive the ACT programme or to watch age appropriate non-interactive cartoons (control procedure). By randomly assigning infants to the ACT or the control procedure, the investigators can be sure that infants in the treatment group do not differ systematically from those in the control group: the two groups will therefore differ only for effect of chance, and the only systematic difference between them will lie in the experimental treatment.
All the assessments will take place in a dedicated room. The use of a dedicated room will ensure that infants are assessed in controlled conditions whereby interference from noise, changes in light, or other sources of distraction, are minimised.
The first session will take place by the time the infant is aged 12 months (age corrected for prematurity). This session will include a baseline assessment followed by a first training/control procedure (depending on the child's random assignment in one group or the other). During the baseline assessment parents will be asked to answer questions about the family and infants' behaviour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 11 Months 至 13 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants born very preterm (gestational age 28 to less than 32 weeks);
- •Infant's family residing in Northern Ireland;
- •Infant's age 12 months (+/- 1 month) at the start of the study, corrected for prematurity
排除标准
- •Significant visual and/or hearing disabilities;
- •Congenital anomalies that may impact on their cognitive and sensory-motor development;
- •A diagnosis of Cerebral Palsy;
- •Infant taking part in a trial (or have recently taken part in a trial) which may interfere with this study (e.g. by affecting concentration abilities or representing a significant burden for the family).
结局指标
主要结局
Recruitment and Retention
时间窗: 1 year
Recruitment as a percentage of the eligible families approached who agreed to take part in the study and were randomised, and retention, defined as the percentage of randomised participants for whom data are available at baseline and post-test.
次要结局
- Performance During Training(1 year)
- Quality of Eye-tracker Data Collected During Baseline and Post-test Attention Assessments(1 year)
- Percentage of Training/Control Sessions Completed by Infants(1 year)
- Percentage of Training/Control Sessions Attended by Infants(1 year)
- Duration of Tasks Administered to Infants During Training/Control Sessions(1 year)
- Percentage of Tasks Completed at Post-test(1 year)
研究者
Oliver Perra
Principal Investigator
Queen's University, Belfast