Language DevelopmentNCT04609553
Literacy Promotion for Latinos Study
A study testing Text messages and Connection to community resources in people with Language Development and Behavior, Child, run by Rutgers, The State University of New Jersey at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Language Development, Behavior, Child, Parenting
- What is being tested?
- Text messages and Connection to community resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 662 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2020to 28 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
About this study
Official title: Addressing Disparities in Language and Social-emotional Skill Acquisition Through Literacy Promotion in Primary Care: 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.
Read the 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.
- Conditions
- Language Development, Behavior, Child, Parenting, Literacy
- Being tested
- Usual care including ROR, Text messages, Connection to community resources
- Keywords
- literacy promotion, early childhood, Latino, primary care
- Medical subject headings
- Child Behavior, Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual care including RORBehavioural
Usual care which includes ROR.
Text messagesBehavioural
3 text messages per week and one interactive text per month.
Connection to community resourcesBehavioural
Referral to a non-profit that connects families with community resources and provides families with case management.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Usual care including ROR; Behavioral: Text messages; Behavioral: Connection to community resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18-month follow-up
Secondary outcomes (6)
Caregiver Attitudes About Reading
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.
Measured: 9-month follow-up, 18-month follow-up
Community Resource Participation
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.
Measured: Baseline, 9-month follow-up, 18-month follow-up
Caregiver-clinician Relationship
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.
Measured: Baseline; 9-month follow-up, 18-month follow-up
Social Needs and Stress
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.
Measured: Baseline, 9-month follow-up, 18-month follow-up
Parent Stress
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.
Measured: Baseline, 9-month follow-up, 18-month follow-up
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.
Measured: Baseline, 9-month follow-up, 18-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start16 Nov 2020
- Primary completion28 Dec 2024
- Study completion28 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Language DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 662 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Manuel E. Jimenez, MD, MS, Rutgers, The State University of New Jersey
- Investigators
- Manuel E Jimenez, MD, MS, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609553
- Sponsor's protocol ID
- Pro2019002784
- Other IDs
- 1R01HD099125-01A1
- Status last verified
- Dec 2025
- First submitted
- 21 Oct 2020
- Last updated
- 9 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified quantitative data and associated documentation may be made available to users conducting non-profit research under a written data-sharing agreement.
Publications
Hemler JR, Jimenez ME, Crabtree BF, Mendelsohn AL, Devine KA, Pai S, Ramachandran U, Hudson SV, Mackie TI. A call for supplemental implementation strategy reporting guidelines to advance minority health: applying expanded specification and reporting recommendations to the Literacy Promotion for Latinos study. Implement Sci Commun. 2026 Jul 3. doi: 10.1186/s43058-026-00966-3. Online ahead of print.
PubMed 42400022Zanzoul 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.
PubMed 38127845
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Disparities in Language and Social-emotional Skill Acquisition Through Literacy Promotion in Primary Care: Literacy Promotion for Latinos Study
- ClinicalTrials.gov ID
- NCT04609553
- Acronym / sponsor ID
- Pro2019002784
- Conditions
- Language Development, Behavior, Child, Parenting, Literacy
- Keywords
- literacy promotion, early childhood, Latino, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 662 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 28 Dec 2024 (actual)
- Study completion
- 28 Dec 2024 (actual)
- First posted
- 30 Oct 2020 (actual)
- Results
- Posted 25 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care including ROR | Active comparator | Behavioral: Usual care including RORLiteracy promotion is a pediatric standard of care. Participants in this group will receive usual care that includes ROR, a primary care literacy promotion intervention. |
| ROR plus text messages | Experimental | Behavioral: Usual care including ROR, Behavioral: Text messagesIn 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. |
| ROR plus text messages plus connection to community resources | Experimental | Behavioral: Usual care including ROR, Behavioral: Text messages, Behavioral: Connection to community resourcesIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual care including RORUsual care which includes ROR. | Behavioural | ROR plus text messages, ROR plus text messages plus connection to community resources, Usual care including ROR |
| Text messages3 text messages per week and one interactive text per month. | Behavioural | ROR plus text messages, ROR plus text messages plus connection to community resources |
| Connection to community resourcesReferral to a non-profit that connects families with community resources and provides families with case management. | Behavioural | ROR plus text messages plus connection to community resources |
Primary outcome
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.
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.
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.
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.
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.
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.
6 secondary outcomes
Caregiver Attitudes About Reading
Time frame: 9-month follow-up, 18-month follow-up
Community Resource Participation
Time frame: Baseline, 9-month follow-up, 18-month follow-up
Caregiver-clinician Relationship
Time frame: Baseline; 9-month follow-up, 18-month follow-up
Social Needs and Stress
Time frame: Baseline, 9-month follow-up, 18-month follow-up
Parent Stress
Time frame: Baseline, 9-month follow-up, 18-month follow-up
Child Media Use
Time frame: Baseline, 9-month follow-up, 18-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42400022Hemler JR, Jimenez ME, Crabtree BF, Mendelsohn AL, Devine KA, Pai S, Ramachandran U, Hudson SV, Mackie TI. A call for supplemental implementation strategy reporting guidelines to advance minority health: applying expanded specification and reporting recommendations to the Literacy Promotion for Latinos study. Implement Sci Commun. 2026 Jul 3. doi: 10.1186/s43058-026-00966-3. Online ahead of print.
- Derived from this study: PubMed 38127845Zanzoul 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.
- Individual participant dataSharing planned: Yes. Deidentified quantitative data and associated documentation may be made available to users conducting non-profit research under a written data-sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel E Jimenez, MD, MS principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text messages and Connection to community resources in people with Language Development and Behavior, Child, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Language Skills (time frame: 18-month follow-up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04609553, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.