Literacy Promotion for Latinos Study

NCT04609553 | Completed Results DMC

• 2 other identifiers: Pro20190027841R01HD099125-01A1
• Study Type: interventional
• Target: 662
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Language Development; Literacy; Behavior, Child; Parenting

Keywords

literacy promotion, early childhood, Latino, primary care

Outcome Measures

Primary Outcomes (6)

• 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

• 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

Secondary Outcomes (6)

• 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

• Parent Stress

  Baseline, 9-month follow-up, 18-month follow-up

Other Outcomes (2)

• ROR Receipt

  Baseline; 9-month follow up; 18-month follow up

• Observed Parent-child Interactions

  9-month follow up

Study Arms (3)

Usual care including ROR

ACTIVE COMPARATOR

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

ROR plus text messages

EXPERIMENTAL

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; Behavioral: Text messages

ROR plus text messages plus connection to community resources

EXPERIMENTAL

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; Behavioral: Text messages; Behavioral: Connection to community resources

Interventions

Usual care including ROR BEHAVIORAL

Usual care which includes ROR.

ROR plus text messages; ROR plus text messages plus connection to community resources; Usual care including ROR

Text messages BEHAVIORAL

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

ROR plus text messages; ROR plus text messages plus connection to community resources

Connection to community resources BEHAVIORAL

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

ROR plus text messages plus connection to community resources

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (1)

• 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.

  PMID: 38127845 DERIVED

MeSH Terms

Conditions

Child Behavior; Literacy

Condition Hierarchy (Ancestors)

Behavior; Communication

Results Point of Contact

• Title: Manuel Jimenez, MD, MS
• Organization: Rutgers University

jimenema@rwjms.rutgers.edu

732-235-9300

Study Officials

• Manuel E Jimenez, MD, MS

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 30, 2020
• Study Start: November 16, 2020
• Primary Completion: December 28, 2024
• Study Completion: December 28, 2024
• Last Updated: December 9, 2025
• Results First Posted: November 25, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will become available after the study is completed and primary study findings are published in peer-reviewed journals.
• 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.

Locations

US (1)