Clinical trial NCT04609553: Literacy Promotion for Latinos Study
Official title: Addressing Disparities in Language and Social-emotional Skill Acquisition Through Literacy Promotion in Primary Care: Literacy Promotion for Latinos Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Language Development
Behavior, Child
Parenting
Literacy
Keywords: literacy promotion, early childhood, Latino, primary care
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-10-30
Enrollment: 630
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Child language skills
timeFrame: 18-month follow-up
measure: Child communicative skills
timeFrame: 9-month follow-up, 18-month follow-up
measure: Child social-emotional skills
timeFrame: Baseline, 9-month follow-up, 18-month follow-up
measure: Caregiver cognitive stimulation
timeFrame: Baseline, 9-month follow-up, 18-month follow-up
measure: Dialogic reading behavior
timeFrame: 9-month follow-up
measure: Caregiver discipline strategies
timeFrame: 18-month follow-up
Secondary outcomes:
measure: Caregiver attitudes about reading
timeFrame: 9-month follow-up, 18-month follow-up
measure: Community resource participation
timeFrame: Baseline, 9-month follow-up, 18-month follow-up
measure: Caregiver-clinician relationship
timeFrame: Baseline; 9-month follow-up, 18-month follow-up
measure: Social needs and stress
timeFrame: Baseline, 9-month follow-up, 18-month follow-up
measure: Parent stress
timeFrame: Baseline, 9-month follow-up, 18-month follow-up
measure: Child media use
timeFrame: Baseline, 9-month follow-up, 18-month follow-up
Other outcomes:
measure: ROR receipt
timeFrame: Baseline; 9-month follow up; 18-month follow up
measure: Observed parent-child interactions
timeFrame: 9-month follow up
Locations:
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical School
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Manuel E Jimenez, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: