Early Intervention in Infants With Unrepaired Cleft Palate: Language, Palatal Function, and Articulation.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- MBCDI (W&G)
研究概览
简要总结
The goal of this clinical trial is to learn if teaching speech skills to infants with cleft palates, prior to palate repair, will help them to develop speech and language skills. It will also learn about whether the skills are linked to fewer speech sound difficulties when they start school. The main questions it aims to answer are:
Do standard, early intervention techniques to promote language development, that are used in children who are late talkers, work in infants with cleft palates? Will infants with cleft palates increase the number of sounds they use after targeted intervention? Can infants attempt to make stop sounds, like b and p, after targeted intervention? Can infants with cleft palate learn new words more quickly when they are used with gestures?
Participants will:
Participate in a baseline evaluation of speech and language skills, either in person, or via Telehealth.
Attend the clinic for twice-weekly visits, for six weeks, to learn techniques to help their infants develop their speech and language skills, in a group setting with other families of infants with cleft palate.
Participate in a final evaluation of speech and language skills, either in person, or via Telehealth.
详细描述
Participants
Participants will be caregiver-infant dyads, where the infant is aged between six and twelve months at the time of study enrolment. Infants should be under the current care of a craniofacial team, with no medical diagnosis that would preclude study participation (e.g., reliance on supplementary oxygen, nasopharyngeal airway in situ).
Caregivers
Caregivers should be over the age of 18 years at the time of study enrolment and be able to participate in the group intervention in the English language, although they may speak more than one language or dialect. Individuals who are not able to consent to study participation (due to the presence of a health condition impeding the ability to give consent) will be excluded from this study. Caregivers should identify either as a primary, or joint-primary, caregiver for the infant. Individuals who are not primary caregivers, but who spent a significant amount of time with the infant and who interact with the infant, are also eligible for study participation. There is no limit on the number of caregivers who can attend sessions with their child, to account for non-traditional family structures.
Recruitment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants with unrepaired cleft palate (with or without cleft lip)
- •Aged between 6 and 10 months at the time of study commencement
排除标准
- •Medically fragile status that would preclude participation in this community-based study.
- •Palatoplasty completed.
- •Aged over one year
- •Infants with cleft lip only
研究组 & 干预措施
Intervention group
All participants will be allocated to this arm; they will receive the intervention as detailed elsewhere in this protocol.
干预措施: Early intervention for language, articulation and palatal function skills (Behavioral)
结局指标
主要结局
MBCDI (W&G)
时间窗: From enrollment to the end of treatment at 8 weeks.
Number of words and concepts, as measured by the MacArthur-Bates Communicative Development Inventory (Words and Gestures)
次要结局
- Plosive attempts(From enrollment until the end of treatment at 8 weeks.)
- Phonemes(From enrollment to the end of treatment at 8 weeks.)
- Canonical babbling: shape(From enrollment to the end of treatment at 8 weeks.)
- Words versus gestures(From study enrollment to end of treatment at 8 weeks.)
- Canonical babbling: frequency(From enrollment to the end of treatment at 8 weeks.)
研究者
Victoria Reynolds
Assistant Professor
Old Dominion University