Literacy Promotion for Latinos Study

NCT ID: NCT04609553

Last Updated: 2025-12-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

662 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-16

Study Completion Date

2024-12-28

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.

Conditions

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Language Development Behavior, Child Parenting Literacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Usual care including ROR

Intervention Type BEHAVIORAL

Usual care which includes ROR.

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.

Group Type EXPERIMENTAL

Usual care including ROR

Intervention Type BEHAVIORAL

Usual care which includes ROR.

Text messages

Intervention Type BEHAVIORAL

3 text messages per week and one interactive text per month.

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.

Group Type EXPERIMENTAL

Usual care including ROR

Intervention Type BEHAVIORAL

Usual care which includes ROR.

Text messages

Intervention Type BEHAVIORAL

3 text messages per week and one interactive text per month.

Connection to community resources

Intervention Type BEHAVIORAL

Referral to a non-profit that connects families with community resources and provides families with case management.

Interventions

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Usual care including ROR

Usual care which includes ROR.

Intervention Type BEHAVIORAL

Text messages

3 text messages per week and one interactive text per month.

Intervention Type BEHAVIORAL

Connection to community resources

Referral to a non-profit that connects families with community resources and provides families with case management.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Manuel E. Jimenez, MD, MS

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manuel E Jimenez, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

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Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38127845 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1R01HD099125-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro2019002784

Identifier Type: -

Identifier Source: org_study_id

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