Literacy Promotion for Latinos Study

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

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.

Study Overview

• Status: Completed
• Conditions: Parenting; Language Development; Behavior, Child; Literacy
• Intervention / Treatment: Behavioral: Usual care including ROR; Behavioral: Text messages; Behavioral: Connection to community resources

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 662
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Robert Wood Johnson Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care including ROR; 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; Usual care which includes ROR.
Experimental: ROR plus text messages; 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; Usual care which includes ROR.; Behavioral: Text messages; 3 text messages per week and one interactive text per month.
Experimental: ROR plus text messages plus connection to community resources; 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; Usual care which includes ROR.; Behavioral: Text messages; 3 text messages per week and one interactive text per month.; Behavioral: Connection to community resources; Referral to a non-profit that connects families with community resources and provides families with case management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 higher scores denote stronger skills.	9-month follow-up, 18-month follow-up
Child Social-emotional Skills	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.	Baseline, 9-month follow-up, 18-month follow-up
Caregiver Cognitive Stimulation	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.	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
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. 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.	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 about reading with children that included positive affect (scores range from 0 to 33). Higher scores indicate more favorable attitudes and greater knowledge.	9-month follow-up, 18-month follow-up
Community Resource Participation	Community resource participation was measured via the Survey of Income and Program Participation (SIPP), a series of questions that asks about caregiver and child participation in different types of community resources (e.g. food/nutrition support, income support, childcare assistance, etc.). Possible scores range from 0 to 17, with higher scores indicating more involvement in community resources.	Baseline, 9-month follow-up, 18-month follow-up
Social Needs and Stress	Caregiver report of social needs and stressors was assessed via the Local Inventory of Needs and Knowledge (LINK) survey. Caregivers rate statements on social needs and stress from 0 to 4 with higher scores indicating greater needs and stress. Possible scores range from 0 to 16 with higher scores indicating greater needs and economic stress.	Baseline, 9-month follow-up, 18-month follow-up
Parent Stress	The Parental Stress Scale is an eighteen-item measure that assesses parental stress. Scores range from 18 to 90 with higher scores indicating greater stress.	Baseline, 9-month follow-up, 18-month follow-up
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
Caregiver-clinician Relationship	The Physician-Parent Communication Survey is a caregiver reported measure of the caregiver-clinician relationship. We analyzed the interest subscale. The interest subscale includes 6 items are scored from 1 to 8. Scores from each item are averaged; thus total possible scores range from 1-8, with higher scores indicating stronger relationships.	Baseline; 9-month follow-up, 18-month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ROR Receipt	Caregiver's report of receipt of literacy promotion components during their previous healthcare visit.	Baseline; 9-month follow up; 18-month follow up
Observed Parent-child Interactions	Observation of parent-child interactions during shared reading and free play; observations will be coded based on DialogPR items	9-month follow up

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Manuel E Jimenez, MD, MS, Rutgers, The State University of New Jersey

Publications and helpful links

General Publications

• Zanzoul S, Strickland PO, Mendelsohn AL, Malke K, Bator A, Hemler J, Jimenez ME. Stress and Infant Media Exposure During COVID-19: A Study Among Latino Families. J Dev Behav Pediatr. 2024 Jan 1;45(1):e14-e20. doi: 10.1097/DBP.0000000000001231. Epub 2023 Dec 21.

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2020
• Primary Completion (Actual): December 28, 2024
• Study Completion (Actual): December 28, 2024

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: October 28, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: literacy promotion, early childhood, Latino, primary care
• Additional Relevant MeSH Terms: Behavior; Communication; Child Behavior; Literacy
• Other Study ID Numbers: Pro2019002784; 1R01HD099125-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified quantitative data and associated documentation may be made available to users conducting non-profit research under a written data-sharing agreement.
• IPD Sharing Time Frame: Data will become available after the study is completed and primary study findings are published in peer-reviewed journals.
• IPD Sharing Access Criteria: Researchers from accredited institutions may request access to the data for non-profit research. Permission and access will be granted on an ad hoc basis. Only deidentified data will be made available.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No