Parent-implemented Intervention for Very Preterm Children With Language Delay
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 67
- 试验地点
- 19
- 主要终点
- language score of the Developmental Neuropsychological assessment (NEPSY)
研究概览
简要总结
In studies of children born at term, language delay at the age of 2 years exhibits a spontaneously favourable course in 30 to 50% by the age of 3 years. In France, there is no recommendation for speech therapy before the age of 3 years. However, for term-born children, parent-implemented language interventions conducted during the third year of life have already shown a positive short-term effect on language skills. In these interventions, a skilled interventionist, generally a speech therapist, teaches parents how to use specific language strategies with their child.
The investigators' hypothesis is that such parent-implemented interventions would be particularly appropriate at short and medium term for the improvement of linguistic performances in very preterm children, a population with a high prevalence of early language delay. Currently, there is an opportunity to partly nest an intervention trial in a national prospective population-based cohort of very preterm children, the EPIPAGE (Etude EPIdémiologique sur les Petits Ages GEstationnels) 2 cohort, which has included 5 000 babies born alive in France in 2011. This situation provides considerable methodological advantages.
详细描述
EPILANG is an open randomized controlled study, in which the final assessment of the children (endpoint) will be conducted by professionals blinded to the treatment group.
Some eligible children will first be screened using the parental questionnaire at 24 months corrected age (CA) of the EPIPAGE 2 cohort. Children with language delay, defined as no words combination and/or less than 30 words from Mac Arthur CDI - short version, and free of exclusion criteria, will be invited to an inclusion visit at 30 months CA, if they are in an EPIPAGE 2 centre participating in the EPILANG trial.
During the inclusion visit, inclusion criteria and the absence of exclusion criteria will be checked, data useful for the study will be collected, and the informed consent of the parents collected. The child will then be randomized either in the control or the intervention group if language delay is still present, defined by a score < 10th percentile at the Mac Arthur CDI. Twins, if both included, will be included in the same group, otherwise only the twin with a language delay will be randomized.
The intervention is organized in 15 weekly one-hour sessions with the child, one or both parents and a speech therapist recruited and trained for the study. Maximum duration for the intervention will be 6 months per child, because some sessions can be missed or delayed. Parents' participation will be recorded.
The usual "wait-and-see" attitude will be provided to the control group, together with basic advice to enhance the child's language at home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 28 Months 至 32 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child born at 24 to 31+6 weeks' gestation, whose parents did not refuse collection of follow-up data
- •Child aged 30 ± 2 months corrected age (CA) at inclusion
- •Child with language delay at 24 months CA, defined as the absence of word combination and/or expressive vocabulary of less than 30 words according to the short version of the French Mac Arthur Communication Developmental Inventories (CDI), whose language delay is confirmed at 30 months CA i.e. without word combination and/or an expressive vocabulary below the 10th percentile on the French CDI.
- •Child with a global Developmental Quotient (DQ) ≥ 55 at 30 months CA
- •Child whose parents accept participation in this study
- •Child with French health insurance coverage
排除标准
- •Child with neurological sequelae (delay or disability) and who is unable to walk without assistance at 24 months CA or who has a global DQ < 55 on the revised Brunet-Lézine (BLR) scale at 30 months CA.
- •Blindness
- •Deafness defined by the prescription of a hearing aid
- •Child with a chromosomal or other condition that could interfere with language development
- •Parents who do not speak French at all
结局指标
主要结局
language score of the Developmental Neuropsychological assessment (NEPSY)
时间窗: at 36 months of corrected age
For the main outcome, mean language score on the NEPSY at the final visit, our primary endpoint, will be compared between groups using linear regression
次要结局
- Other scores of the NEPSY battery(at 36 months of corrected age)
- Parenting Stress Index (PSI) questionnaire(at 36 months of corrected age)
- Strengths and Difficulties Questionnaire(at 36 months of corrected age)