Delivering Enhanced Milieu Teaching (EM-Teach) Via Telehealth to Children and Families in Rural Communities
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in Parent use of EMT Strategies during a parent child interaction.
研究概览
简要总结
In the U.S., approximately 12% of children under 36 months have language impairments, yet less than 2% receive early language intervention. Early language intervention is underutilized nationally, with pronounced service gaps in rural communities. This gap is a significant issue because children with language impairments are at increased risk for learning and reading disabilities that can persist into adulthood. Telehealth has the potential to mitigate service gaps by improving access to treatments, increasing the availability of clinicians with expertise in language intervention, and reducing healthcare costs. Telehealth can alleviate logistic and geographic barriers to treatment facing children with disabilities and their families in rural communities. However, there is insufficient evidence on the effects of telehealth interventions for children with language impairments under 36 months. Consequently, there is an urgent need to explore innovative telehealth interventions with potential to improve the quality and efficiency of language treatments. The investigators will conduct a feasibility trial (small randomized control trial) to evaluate a telehealth intervention for children with language impairments and their caregivers.
详细描述
Aim 1: Explore stakeholders' preferences, experiences, and information needs regarding the delivery of language interventions via telehealth. Ethnographic interviews will be conducted with 16 stakeholders (n= 8 caregivers, 8 clinicians) to explore their preferences, experiences, and needs.
Aim 2: Determine the effect of telehealth Enhanced Milieu Teaching on caregiver language strategy use. Caregiver language strategy use will be compared between the intervention and control groups (n = 28 families, 14 intervention,14 control) during semi-structured caregiver-child interactions.
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 assessor of the primary outcome will be blind to treatment condition.
入排标准
- 年龄范围
- 18 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(a) Child age between 18 and 36 months
- •(b) developmental age of 9 months as measured on the Visual Reception Scale of the Mullen Scales of Early Learning (MSEL; 1995)
- •(c) language delay as measured by a score of at least 1.33 SD below the mean on the Preschool Language Sclaes-5th Edition (PLS-5; Zimmerman, Steiner, & Evatt-Pond, 2011), and
- •(d) hearing (with or without amplification) reported at 25dB HL or better confirmed by audiological testing, or medical record.
排除标准
- •(a) primary diagnosis of any specific disability other than a language impairment including severe motor impairment
- •(b) concomitant sensory impairments (e.g., hearing impairment, blindness), and
- •(c) symptoms of autism spectrum disorder as measured by a result indicating "high risk" for autism (e.g., scores of 8 or higher) on the Modified Checklist for Autism In Toddlers-Revised with Follow-up (MCHAT-R/F Robins, Fein & Barton, 2009).
结局指标
主要结局
Change in Parent use of EMT Strategies during a parent child interaction.
时间窗: 1 pre-intervention assessment (start of study) and 1 post intervention assessment through study completion (3-4 months later).
A parent-child interaction is a brief, repeatable, play-based, observational measure of a child's communicative performance during a 10-minute play period with the parent who agreed to participate in as a research volunteer in the study. It measures the number and percentage of correct of matched turns, expansions, time delays, and milieu teaching episodes during this play period. An increase in the Parent use of EMT strategies is a positive outcome. Metric/ Measurement Unit: Number and percentage of turns parents used EMT Strategies (e.g. matched turns, expansions, time delays, and milieu teaching episodes) during a 10 minute play interaction.
次要结局
- Change in Preschool-Language Scales - 5th edition (PLS-5)(1 pre-intervention assessment (start of study) and 1 post intervention assessment through study completion (3-4 months later).)
- Change in Productive Vocabulary on the Mac-Arthur Bates Communication Development Inventory (MCDI) score after 3-4 months of intervention(1 pre-intervention assessment (start of study) and 1 post intervention assessment through study completion (3-4 months later).)
- Change in Individual Growth and Development Indicators for Infants and Toddlers- Early Communication Indicator (IGDI-ECI) score through 3-4 months of intervention(Once per month of intervention through study completion (3-4 months of intervention))
- Change in number of Different Words on Structured Language Sample(1 pre-intervention assessment (start of study) and 1 post intervention assessment through study completion (3-4 months later).)
研究者
Emily Quinn
Principal Investigator
Oregon Health and Science University