Literacy Promotion for Latinos Study

Parenting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04609553
• Other study ID #: Pro2019002784
• Secondary ID: 1R01HD099125-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 16, 2020
• Est. completion date: February 2025

Study information

• Verified date: June 2024
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 630
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Child
• Language Development
• Literacy
• Parenting

Intervention

Behavioral:
• Usual care including ROR
Usual care which includes ROR.
• Text messages
3 text messages per week and one interactive text per month.
• Connection to community resources
Referral to a non-profit that connects families with community resources and provides families with case management.

Locations

Country	Name	City	State
United States	Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ROR receipt	Caregiver's report of receipt of literacy promotion components during healthcare visits.	Baseline; 9-month follow up; 18-month follow up
Other	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
Primary	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. Higher scores denote stronger skills	18-month follow-up
Primary	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 measured in percentiles ranging <1st to 99th. Higher scores denote stronger skills.	9-month follow-up, 18-month follow-up
Primary	Change in child social-emotional skills	Caregiver report of infant and toddler social-emotional skills assessed using the Devereux Early Childhood Assessment (DECA). Total Protective Factors scale is a composite of Attachment/Relationships, Initiative, and Self-Regulation scales. Scores are standardized on a T-distribution (M=50;SD=10). Higher scores denote strengths.	Baseline, 9-month follow-up, 18-month follow-up
Primary	Change in caregiver cognitive stimulation	The StimQ 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	Baseline, 9-month follow-up, 18-month follow-up
Primary	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
Primary	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	Caregiver attitudes about reading	The Parent Reading Belief Inventory is a caregiver reported measure of attitudes and knowledge about reading with children that includes subdimensions of positive affect (scores range from 0 to 33) and knowledge (scores range from 0 to 15). Higher scores indicate more favorable attitudes and greater knowledge.	9-month follow-up, 18-month follow-up
Secondary	Change in community resource participation	A series of questions that ask about caregiver and child participation in different types of community resources (e.g. food/nutrition support, income support, childcare assistance, etc.).	Baseline, 9-month follow-up, 18-month follow-up
Secondary	Change in caregiver-clinician relationship	The Physician-Parent Communication Survey is a caregiver reported measure of the caregiver-clinician relationship that examines subdimensions including interest and caring. Items are scored from 1 to 8 with higher scores indicating stronger relationships.	Baseline; 9-month follow-up, 18-month follow-up
Secondary	Change in social needs and stress	Caregiver report of social needs and stressors. Caregivers rate statements on social needs and stress from 0 to 4 with higher scores indicating greater needs and stress.	Baseline, 9-month follow-up, 18-month follow-up
Secondary	Change in parent stress	The Parental Stress Scale is an eighteen-item measure that assesses parental stress. Scores range from 5 to 90 with higher scores indicating greater stress.	Baseline, 9-month follow-up, 18-month follow-up
Secondary	Change in 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