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Completed

NCT Number: NCT04609553

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual care including ROR

Behavioral

Usual care which includes ROR.

Text Messages

Behavioral

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

Connection to community resources

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Other outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 30, 2020
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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