Spanish eTIPS: Translation, Cross-Cultural Adaptation, and Pilot Randomized Feasibility Study of Early Therapy in Perinatal Stroke for Spanish-Speaking Families
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
This study adapts and evaluates the Spanish version of eTIPS, an early home-based therapy program for infants at risk of unilateral cerebral palsy after perinatal stroke. The project has three parts: translation and cultural adaptation of the original materials, a pilot randomized feasibility study comparing eTIPS with usual care, and a qualitative study exploring family experiences, barriers, and facilitators to using the program at home.
In the first part, the study team will translate and culturally adapt the eTIPS materials for Spanish-speaking families, review them with experts, and test whether the content is clear, relevant, and usable. In the second part, families with infants diagnosed with perinatal stroke or at high risk of unilateral cerebral palsy will be assigned to either the eTIPS program or usual clinical care to assess recruitment, retention, adherence, safety, acceptability, and preliminary effects on infant motor development and family outcomes. In the third part, caregivers in the intervention group will take part in interviews to better understand how the program fits into daily life and what could improve future implementation.
详细描述
This is a mixed-methods study designed to translate, culturally adapt, and evaluate the Spanish version of eTIPS, an early, parent-delivered therapy program originally developed for infants with perinatal stroke and risk of unilateral cerebral palsy. The project follows a staged approach with three linked phases: Phase I, translation and cross-cultural adaptation of the intervention materials; Phase II, a pilot randomized feasibility study; and Phase III, a qualitative study of family experiences and implementation.
Phase I will include forward translation, back-translation, expert review, and feedback from caregivers and professionals to ensure semantic, conceptual, and cultural equivalence of the Spanish materials. Phase II will randomize eligible infants to eTIPS or usual care, with the intervention delivered by caregivers in the home environment and supported by the research team. Outcomes in this phase will focus on feasibility and process measures such as eligibility, recruitment, consent, retention, adherence, usability, safety, and fidelity, as well as exploratory infant and caregiver outcomes.
The infant assessments may include measures of hand function, motor development, neurological status, and stroke-related outcomes, while caregiver outcomes may include well-being, stress, competence, and bonding. Phase III will use semi-structured interviews and thematic analysis to explore how caregivers experience the intervention in everyday routines, including perceived benefits, barriers, facilitators, and suggestions for improvement. The results will be used to refine the Spanish eTIPS program and inform the design of a future definitive multicenter trial.
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)
盲法说明
The intervention is open label for participants and care providers. Where possible, outcome assessment should be performed by an independent assessor masked to group assignment.
入排标准
- 年龄范围
- 0 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants with confirmed unilateral perinatal stroke diagnosis by neuroimaging, identified within first 3 months of life
- •Age at recruitment ≤3 months postnatal (intervention starts when clinically stable, maximum term-equivalent age)
- •Written informed consent from parents/legal guardians
排除标准
- •Known progressive neurodegenerative disorder or severe medical comorbidity preventing participation (e.g., ventilation-dependent respiratory failure)
- •Extensive bilateral intracerebral lesion making lateralized intervention irrelevant
- •Concurrent participation in another clinical trial with interfering treatment