Literacy Promotion for Latinos Study

December 2, 2025 updated by: Manuel E. Jimenez, MD, MS, Rutgers, The State University of New Jersey

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
662

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Child Communicative Skills
Time Frame: 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.
9-month follow-up, 18-month follow-up
Child Social-emotional Skills
Time Frame: 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.
Baseline, 9-month follow-up, 18-month follow-up
Caregiver Cognitive Stimulation
Time Frame: 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.
Baseline, 9-month follow-up, 18-month follow-up
Dialogic Reading Behavior
Time Frame: 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.
9-month follow-up
Caregiver Discipline Strategies
Time Frame: 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.
18-month follow-up
Child Language Skills
Time Frame: 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.
18-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Caregiver Attitudes About Reading
Time Frame: 9-month follow-up, 18-month follow-up
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
Time Frame: Baseline, 9-month follow-up, 18-month follow-up
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
Time Frame: Baseline, 9-month follow-up, 18-month follow-up
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
Time Frame: Baseline, 9-month follow-up, 18-month follow-up
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
Time Frame: Baseline, 9-month follow-up, 18-month follow-up
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
Time Frame: Baseline; 9-month follow-up, 18-month follow-up
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ROR Receipt
Time Frame: Baseline; 9-month follow up; 18-month follow up
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
Time Frame: 9-month follow up
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rutgers, The State University of New Jersey

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Manuel E Jimenez, MD, MS, Rutgers, The State University of New Jersey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 28, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 28, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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