Literacy Promotion for Latinos Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Addressing Disparities in Language and Social-emotional Skill Acquisition Through Literacy Promotion in Primary Care: Literacy Promotion for Latinos Study

Conditions
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Language Development, Behavior, Child, Parenting, Literacy

Intervention / Treatment
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* Behavioral: Usual care including ROR
* Behavioral: Text messages
* Behavioral: Connection to community resources


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care including ROR<br>Literacy promotion is a pediatric standard of care. Participants in this group will receive usual care that includes ROR, a primary care literacy promotion intervention. | Behavioral: Usual care including ROR<br>* Usual care which includes ROR.<br>|
| Experimental: ROR plus text messages<br>In addition to ROR, participants will receive three text messages per week, plus one interactive follow-up message per month, for the study period with scheduled breaks. | Behavioral: Usual care including ROR<br>* Usual care which includes ROR.<br>Behavioral: Text messages<br>* 3 text messages per week and one interactive text per month.<br>|
| Experimental: ROR plus text messages plus connection to community resources<br>In addition to ROR and text messages, participants will be referred to a county-based single point of entry system for referrals to community resources. This system simplifies access to poverty-reducing resources by creating a centralized access point, maintaining an updated data base of resources with existing capacity to support families, and providing case management. | Behavioral: Usual care including ROR<br>* Usual care which includes ROR.<br>Behavioral: Text messages<br>* 3 text messages per week and one interactive text per month.<br>Behavioral: Connection to community resources<br>* Referral to a non-profit that connects families with community resources and provides families with case management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child language skills | 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. Higher scores denote stronger skills | 18-month follow-up | 
| Child communicative skills | 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 measured in percentiles ranging <1st to 99th. Higher scores denote stronger skills. | 9-month follow-up, 18-month follow-up | 
| Change in child social-emotional skills | Caregiver report of infant and toddler social-emotional skills assessed using the Devereux Early Childhood Assessment (DECA). Total Protective Factors scale is a composite of Attachment/Relationships, Initiative, and Self-Regulation scales. Scores are standardized on a T-distribution (M=50;SD=10). Higher scores denote strengths. | Baseline, 9-month follow-up, 18-month follow-up | 
| Change in caregiver cognitive stimulation | The StimQ 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 | Baseline, 9-month follow-up, 18-month follow-up | 
| Dialogic reading behavior | The DialogPR is a caregiver report measure of shared reading quality. Score range from 0 to 30 with higher scores indicating more interactive reading. | 9-month follow-up | 
| Caregiver discipline strategies | 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. | 18-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver attitudes about reading | The Parent Reading Belief Inventory is a caregiver reported measure of attitudes and knowledge about reading with children that includes subdimensions of positive affect (scores range from 0 to 33) and knowledge (scores range from 0 to 15). Higher scores indicate more favorable attitudes and greater knowledge. | 9-month follow-up, 18-month follow-up | 
| Change in community resource participation | A series of questions that ask about caregiver and child participation in different types of community resources (e.g. food/nutrition support, income support, childcare assistance, etc.). | Baseline, 9-month follow-up, 18-month follow-up | 
| Change in caregiver-clinician relationship | The Physician-Parent Communication Survey is a caregiver reported measure of the caregiver-clinician relationship that examines subdimensions including interest and caring. Items are scored from 1 to 8 with higher scores indicating stronger relationships. | Baseline; 9-month follow-up, 18-month follow-up | 
| Change in social needs and stress | Caregiver report of social needs and stressors. Caregivers rate statements on social needs and stress from 0 to 4 with higher scores indicating greater needs and stress. | Baseline, 9-month follow-up, 18-month follow-up | 
| Change in parent stress | The Parental Stress Scale is an eighteen-item measure that assesses parental stress. Scores range from 5 to 90 with higher scores indicating greater stress. | Baseline, 9-month follow-up, 18-month follow-up | 
| Change in child media use | The ScreenQ is a caregiver report measure of media use in children. Scores range from 0 to 26 with higher score indicating more media use. | Baseline, 9-month follow-up, 18-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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literacy promotion, early childhood, Latino, primary care