跳至主要内容
临床试验/NCT04692519
NCT04692519Unknown不适用

Duet 2.0: Starting the Conversation: A New Intervention Model to Stimulate Language Growth in Underserved Populations

Temple University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年12月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Change in MacArthur-Bates Communication Development Inventories (MBCDI)

研究概览

简要总结

Caregiver-child language interactions in the first three years of life predict early language development, school readiness, and academic achievement. Despite the importance of these factors, there are disparities in the frequency and quality of children's early language interactions. Although there is within-group variability, children from low-income families, on average, have fewer and lower-quality language experiences than their middle- or high-income peers. The current study addresses a need in the community for an early language intervention accessible to low-income families who speak Spanish. This study will build upon research conducted in a previous study, "Enhancing the Communication Foundation-The Duet Project", by piloting the English and Spanish modules with families through a light-touch, remote intervention delivery model. Temple University Health System's Department of Pediatrics will aid in identifying participants. Baseline and follow-up measures will be used to evaluate caregiver knowledge of child development, psychosocial perceptions, demographics, caregiver-child language interaction quality, and child language skills. It is hypothesized that dyads who receive the intervention will make greater gains in early interaction quality, knowledge of child development, and child language skills than the delayed-access control group. This work has the potential to shape early intervention design and implementation for people in underserved communities across the country.

详细描述

Objectives and Background

The purpose of this study is to determine whether Duet 2.0- a light-touch, public health model of remote intervention delivery 1) increases caregiver knowledge about children's language development, 2) improves caregiver-child language interaction quantity and quality, and 3) enhances children's language skills. It is hypothesized that dyads who receive the Duet 2.0 intervention will make greater gains in knowledge of child development, early interaction quality, and child language skills than the delayed-access control group. Secondary analyses will be conducted to examine if and how parent (e.g., self-efficacy) and child (e.g., child language abilities) characteristics relate to each other, baseline measures, and treatment outcomes.

Early language skills are fundamental to language, cognitive, and socioemotional development and are the single best predictors of later academic success. Caregiver-child language interactions in the first three years of life not only predict early language development, but also influence school readiness skills and academic achievement. High-quality early language interactions are characterized by rich and diverse vocabulary, responsive talk (i.e., language following the child's attention), decontextualized language (e.g., language beyond the here and now context, "Remember we went to a party last night"), communication foundation (e.g., use of verbal and gestural symbols, engaging in back-and-forth conversations), and question use. In fact, early reading outcomes are particularly contingent on strong language skills that go beyond and accompany strong decoding skills.

Despite the importance of these factors, there are large disparities in the frequency and quality of children's early language interactions. Although there is great within-group variability, children from low-income families on average have fewer and lower-quality language experiences than their middle- or high-income peers. Early disparities in language experiences can lead to gaps in language skills and academic achievement that persist into adulthood.

Duet 2.0 will adopt an innovative and scalable approach-remote delivery and coaching. This design reflects arguably the strongest evidence for successful intervention. Remote coaching and telehealth are becoming accepted models for public health intervention in domains like nutrition, fitness, heart health, and diabetes. There is also growing support for remote delivery parent and teacher training programs. For instance, remote coaching has effectively improved Head Start teachers' language and literacy practices. This intervention model has also been used successfully to promote mental health in parents of infants, train parents in domains such as child socioemotional development, and support language and communication in young children with autism.

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
Double (Investigator, Outcomes Assessor)

盲法说明

The principal investigator and postdoctoral fellow on the project will both be blind. Only the coordinator will know who is the in intervention group and who is in the delayed access group.

入排标准

年龄范围
12 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •To be included in this study, Caregivers (Control and Intervention Groups)
  • •Caregivers must:
  • •Live in a zip code that is within a 30-mile radius of Weiss Hall at Temple University
  • •Be 18;0 years of age or older
  • •Be a parent or legal guardian of participating child
  • •Speak English and/or Spanish (at least 80% of the time)
  • •Read English and/or Spanish "well" or "very well"
  • •Have weekly access to phone or internet
  • •Have adequate visual abilities to participate in the study (per participant report)
  • •Have no hearing impairment or loss (per participant report) OR if some hearing impairment or loss, have received amplification (e.g., hearing aid, cochlear implants) and speak spoken (e.g., not signed) language as their primary mode of communication (per participant report).
  • •Qualify as Low-Socioeconomic Status (Low-SES), which is defined as, being at or below 200% of the Federal Poverty Guideline (FPG) and having no more than a 4-year college degree
  • •To be included in this study, children (Control and Intervention Groups) must:
  • •a. Be between 12 and 30 months at baseline b. Be Spanish and/or English learners (at least 80% of the time), as defined by c. Have already acquired verbal or non-verbal intentional language (e.g., gesture to get someone's attention and/or point to request and obtain a toy) and speak no more than three-word utterances (per caregiver report) d. Have adequate visual abilities to participate in the study (per caregiver report) e. Have no hearing impairment or loss (per caregiver report) OR if some hearing impairment or loss, have received amplification (e.g., hearing aid, cochlear implants) and be learning spoken (e.g., not signed) language as their primary mode of communication (per caregiver report).

排除标准

  • 未提供

研究组 & 干预措施

Intervention

Experimental

The Duet 2.0 intervention is comprised of six training modules, which include behavioral strategies, real-life and animated examples of high-quality early language interactions, and interactive scenarios. Modules were translated into Spanish. Participants will watch one Duet intervention module a week and have up to 3 months to complete all 6 modules. As intervention families review the modules on their own time at home, they will receive remote coaching from an assigned interventionist and weekly module-specific fidelity/comprehension questions. Interventionists will check-in weekly via phone or video (~30-60 minutes), whichever is more convenient for the family. During the check-in, interventionists will do teach-back about the module, guide the family on how to incorporate the strategies into their daily lives, and provide feedback. Intervention participants will be scheduled for follow-up data collection at 3 months, 6 months, and pending funding, 1-year after baseline.

干预措施: Duet Language Intervention Modules (Behavioral)

Delayed Access

No Intervention

Participants who are in the delayed access control group will not have to complete the modules and will be scheduled for a 3-month, 6-month, and pending funding, a 1-year follow-up calls. They will have delayed access to the modules, which means that they will receive access to the module videos at their 6-month study session and will be offered the opportunity to contact the research team with any questions.

结局指标

主要结局

Change in MacArthur-Bates Communication Development Inventories (MBCDI)

时间窗: Baseline, 3-month follow-up, and 6-month follow-up

The MacArthur-Bates Communication Development Inventories (MBCDI) will be given to caregivers at baseline and follow-up sessions to measure children's vocabulary. The more vocabulary words on the MBCDI that a parent reports that their child knows, the larger the child's vocabulary.

Change in Quality of Caregiver-Child Language Interaction

时间窗: Baseline, 3-month follow-up, and 6-month follow-up

To assess the quality of caregiver-child interactions, caregivers and participating children will be filmed or film themselves for a total of 10-15 minutes, at baseline, 3-month, and 6-month follow-up sessions. We will calculate the number of conversational turns.

Change in Parent/Provider Expectations and Knowledge

时间窗: Baseline, 3-month follow-up, and 6-month follow-up

Caregiver's knowledge of child development will be assessed at baseline and post intervention. The Parent/Provider Expectations and Knowledge-II (SPEAK-II) is a well-validated measure used in similar research. Higher scores on the SPEAK-II indicate more knowledge about early language development.

次要结局

  • Change in Self-Efficacy for Parenting Tasks-Toddler Scale(Baseline, 3-month follow-up, and 6-month follow-up)
  • Change in Langauge Diversity(Baseline, 3-month follow-up, and 6-month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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