Addressing Disparities in Language and Social-emotional Skill Acquisition Through Literacy Promotion in Primary Care: Literacy Promotion for Latinos Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 662
- 试验地点
- 2
- 主要终点
- Caregiver Discipline Strategies
研究概览
简要总结
This study tests the extent to which tailored outreach text messages that provide a cue to action and an intervention that enhances access to poverty-reducing resources, in combination with standard primary care literacy promotion, can improve child language and social- emotional skill acquisition among low-income Latino children.
详细描述
The investigators propose a 3 arm randomized clinical trial to test strategies designed to enhance literacy promotion for low-income Latino families. The investigators will recruit 630 parent-child dyads from community health centers that serve low-income, Latino families. Parents will be randomly assigned to one of 3 arms (1) Reach Out and Read (ROR) an evidence-based literacy promotion intervention that is widely disseminated in primary care; (2) ROR plus tailored outreach text messages; (3) ROR plus tailored outreach text messages and enhanced access to poverty-reducing resources using a widely disseminated model that simplifies access and provides care coordination. In Aim 1, the investigators will test their hypotheses that (1) children in the ROR plus text message arm will have higher scores on validated assessments of language and social-emotional development compared to standard ROR alone and (2) children who receive both text messages and enhanced access to poverty-reducing resources will have higher scores compared to the other two arms. In Aim 2, the investigators will examine mechanisms that underlie the effects of the interventions. In Aim 3, the investigators will use mixed methods to conduct a process evaluation to understand how the interventions are implemented, identify barriers, facilitators, and modifications, and explore parents' experiences with the interventions.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary caregiver of a child age 6 months to 12 months
- •Identifies as Latino/a/x
- •Primary language English or Spanish
- •Cell phone ownership
- •Age 18 years or older
- •Willing to receive text messages
- •Willing to accept being placed into one of three study groups
排除标准
- •Children with multiple congenital anomalies or genetic disorders and previously identified developmental delays
- •Individuals unable to provide informed consent
- •Intent to discontinue care at current pediatric clinic / recruitment site
- •Discontinued care at one of the three pediatric clinics / recruitment sites
结局指标
主要结局
Caregiver Discipline Strategies
时间窗: 18-month follow-up
This questionnaire was modified from the National Survey of Early Childhood Health and asks two questions about verbal and physical discipline. Scores range from 0 to 6 and higher scores indicate harsher discipline strategies.
Child Language Skills
时间窗: 18-month follow-up
Expressive One-Word Picture Vocabulary Test - Fourth Edition (EOWPVT-4) Spanish-Bilingual - Assesses expressive language skills in English and Spanish. This multiple-choice format test consists of 190 items presented in developmental sequence; age-related starting points and cut-off points ensure that only a subset of items is administered. Raw scores are converted into standard scores (M=100, SD=15). Higher scores denote stronger language skills, with possible standard scores ranging between 55 and 145.
Child Communicative Skills
时间窗: 9-month follow-up, 18-month follow-up
Caregiver report of non-verbal communication and early expressive language assessed using the MacArthur Bates Communicative Development Inventories. The Words \& Gestures short form is an 89-word vocabulary checklist with separate columns for comprehension and production for children 8-18 months. The Words \& Sentences versions contain a 100-word productive vocabulary checklist and a question about combining words for children 16-30 months. Scores are summed and higher scores denote stronger skills.
Child Social-emotional Skills
时间窗: Baseline, 9-month follow-up, 18-month follow-up
Child's social-emotional skills were assessed with the Devereux Early Childhood Assessment for Infants and Toddlers (DECA-I/T), which has 2 caregiver-report forms: an infant form (1-18 months) that includes Attachment/Relationships and Initiative subscales, and a toddler form (18-36 months) that includes Attachment/Relationships, Initiative, and Self-Regulation subscales. Scores are standardized on a T-distribution (M=50; SD=10). The Total Protective Factors score is calculated by adding subscale T-scores. T-scores of 60+ indicate an area strength, and T-scores of 40- indicate an area need.
Caregiver Cognitive Stimulation
时间窗: Baseline, 9-month follow-up, 18-month follow-up
The StimQ2 is a caregiver-reported measure of cognitive stimulation for children that includes domains on the home literacy environment (Reading scale) and responsiveness (Parental Verbal Responsiveness scale). The Reading scale includes 3 subdimensions (Book Reading Quantity, Diversity of Content, Book Reading Quality). Scores on the Reading scale range from 0 to 19. The Parental Verbal Responsiveness scale is composed of two subdimensions (Everyday Routines and Play and Pretend). Scores range from 0 to 15. Higher scores indicate more cognitive stimulation. The Reading scale was completed at baseline, the 9-month follow-up, and the 18-month follow-up. The Parent Verbal Responsiveness scale was completed at the 9-month follow-up and the18-month follow-up.
Dialogic Reading Behavior
时间窗: 9-month follow-up
The DialogPR is a caregiver report measure of shared reading quality. Score range from 0 to 30 with higher scores indicating more interactive reading.
Child Communicative Skills
时间窗: 9-month follow-up, 18-month follow-up
Caregiver report of non-verbal communication and early expressive language assessed using the MacArthur Bates Communicative Development Inventories. The Words \& Gestures short form is an 89-word vocabulary checklist with separate columns for comprehension and production for children 8-18 months. The Words \& Sentences versions contain a 100-word productive vocabulary checklist and a question about combining words for children 16-30 months. Scores are summed and higher scores denote stronger skills.
Caregiver Discipline Strategies
时间窗: 18-month follow-up
This questionnaire was modified from the National Survey of Early Childhood Health and asks two questions about verbal and physical discipline. Scores range from 0 to 6 and higher scores indicate harsher discipline strategies.
Child Language Skills
时间窗: 18-month follow-up
Expressive One-Word Picture Vocabulary Test - Fourth Edition (EOWPVT-4) Spanish-Bilingual - Assesses expressive language skills in English and Spanish. This multiple-choice format test consists of 190 items presented in developmental sequence; age-related starting points and cut-off points ensure that only a subset of items is administered. Raw scores are converted into standard scores (M=100, SD=15). Higher scores denote stronger language skills, with possible standard scores ranging between 55 and 145.
Child Social-emotional Skills
时间窗: Baseline, 9-month follow-up, 18-month follow-up
Child's social-emotional skills were assessed with the Devereux Early Childhood Assessment for Infants and Toddlers (DECA-I/T), which has 2 caregiver-report forms: an infant form (1-18 months) that includes Attachment/Relationships and Initiative subscales, and a toddler form (18-36 months) that includes Attachment/Relationships, Initiative, and Self-Regulation subscales. Scores are standardized on a T-distribution (M=50; SD=10). The Total Protective Factors score is calculated by adding subscale T-scores. T-scores of 60+ indicate an area strength, and T-scores of 40- indicate an area need.
Caregiver Cognitive Stimulation
时间窗: Baseline, 9-month follow-up, 18-month follow-up
The StimQ2 is a caregiver-reported measure of cognitive stimulation for children that includes domains on the home literacy environment (Reading scale) and responsiveness (Parental Verbal Responsiveness scale). The Reading scale includes 3 subdimensions (Book Reading Quantity, Diversity of Content, Book Reading Quality). Scores on the Reading scale range from 0 to 19. The Parental Verbal Responsiveness scale is composed of two subdimensions (Everyday Routines and Play and Pretend). Scores range from 0 to 15. Higher scores indicate more cognitive stimulation. The Reading scale was completed at baseline, the 9-month follow-up, and the 18-month follow-up. The Parent Verbal Responsiveness scale was completed at the 9-month follow-up and the18-month follow-up.
Dialogic Reading Behavior
时间窗: 9-month follow-up
The DialogPR is a caregiver report measure of shared reading quality. Score range from 0 to 30 with higher scores indicating more interactive reading.
次要结局
- Parent Stress(Baseline, 9-month follow-up, 18-month follow-up)
- Caregiver Attitudes About Reading(9-month follow-up, 18-month follow-up)
- Community Resource Participation(Baseline, 9-month follow-up, 18-month follow-up)
- Caregiver-clinician Relationship(Baseline; 9-month follow-up, 18-month follow-up)
- Social Needs and Stress(Baseline, 9-month follow-up, 18-month follow-up)
- Child Media Use(Baseline, 9-month follow-up, 18-month follow-up)
- Community Resource Participation(Baseline, 9-month follow-up, 18-month follow-up)
- Social Needs and Stress(Baseline, 9-month follow-up, 18-month follow-up)
- Caregiver Attitudes About Reading(9-month follow-up, 18-month follow-up)
- Caregiver-clinician Relationship(Baseline; 9-month follow-up, 18-month follow-up)
- Parent Stress(Baseline, 9-month follow-up, 18-month follow-up)
- Child Media Use(Baseline, 9-month follow-up, 18-month follow-up)
研究者
Manuel E. Jimenez, MD, MS
Associate Professor
Rutgers, The State University of New Jersey