An interventional study of Usual care including ROR and Text messages in Language Development, Behavior, Child and Parenting, sponsored by Rutgers, The State University of New Jersey. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by Rutgers, The State University of New Jersey · Not applicable, Interventional, and Prevention
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.
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.
224 studies on the registry are indexed under Child Behavior; 41 are open to participants now.
This study's enrollment of 662 is above the median of 140 across 197 interventional studies indexed under Child Behavior.
Browse Child Behavior studies →Rutgers, The State University of New Jersey is the lead sponsor of 506 studies on the registry; 131 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 31 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Usual care which includes ROR.
3 text messages per week and one interactive text per month.
Referral to a non-profit that connects families with community resources and provides families with case management.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 18-month follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 9-month follow-up, 18-month follow-up
ROR Receipt
Caregiver's report of receipt of literacy promotion components during their previous healthcare visit.
Time frame: Baseline; 9-month follow up; 18-month follow up
Observed Parent-child Interactions
Observation of parent-child interactions during shared reading and free play; observations will be coded based on DialogPR items
Time frame: 9-month follow up
Participants were recruited from three health centers in central New Jersey between November 2020 and June 2023.
| Milestone | Usual care including ROR | ROR plus text messages | ROR plus text messages plus connection to community resources |
|---|---|---|---|
| Started | 209 | 210 | 211 |
| 9-month follow up | 168 | 173 | 178 |
| Completed | 170 | 169 | 178 |
| Not completed | 39 | 41 | 33 |
| Withdrew: Lost to follow-up | 27 | 31 | 24 |
| Withdrew: Discontinued | 12 | 10 | 9 |
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.
| score on a scale | Usual care including ROR | ROR plus text messages | ROR plus text messages plus connection to community resources |
|---|---|---|---|
| Child Language Skills | 2.1 ± 4.2 | 2.3 ± 4.2 | 2.6 ± 4.4 |
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.
| score on a scale | Usual care including ROR | ROR plus text messages | ROR plus text messages plus connection to community resources |
|---|---|---|---|
| 9-month follow-up | 12.5 ± 13.7 | 13.5 ± 14.4 | 15.7 ± 20.9 |
| 18-month follow-up | 44.5 ± 32.2 | 50.4 ± 30.8 | 46.6 ± 32.1 |
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.
| T-score | Usual care including ROR | ROR plus text messages | ROR plus text messages plus connection to community resources |
|---|---|---|---|
| Baseline | 95.7 ± 18.3 | 93.8 ± 17.8 | 94.5 ± 18.3 |
| 9-month follow-up | 88.4 ± 17.2 | 87.9 ± 19.2 | 91.4 ± 18.9 |
| 18-month follow-up | 133.5 ± 26.5 | 138.4 ± 28.4 | 140.6 ± 24.6 |
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.
| score on a scale | Usual care including ROR | ROR plus text messages | ROR plus text messages plus connection to community resources |
|---|---|---|---|
| Baseline (Reading) | 4.5 ± 3.9 | 4.0 ± 3.9 | 4.2 ± 3.9 |
| 9-month follow-up (Reading) | 6.0 ± 3.8 | 6.7 ± 3.5 | 6.1 ± 3.8 |
| 18-month follow-up (Reading) | 6.6 ± 4.2 | 6.8 ± 4.0 | 6.7 ± 4.1 |
| 9-month follow-up (Parent Verbal Responsiveness) | 5.5 ± 2.3 | 5.8 ± 2.1 | 6.1 ± 2.0 |
| 18-month follow-up (Parent Verbal Responsiveness) | 6.5 ± 1.9 | 6.4 ± 2.1 | 6.8 ± 1.9 |
The DialogPR is a caregiver report measure of shared reading quality. Score range from 0 to 30 with higher scores indicating more interactive reading.
| score on a scale | Usual care including ROR | ROR plus text messages | ROR plus text messages plus connection to community resources |
|---|---|---|---|
| Dialogic Reading Behavior | 16.7 ± 10.0 | 18.1 ± 8.8 | 17.3 ± 10.1 |
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.
| score on a scale | Usual care including ROR | ROR plus text messages | ROR plus text messages plus connection to community resources |
|---|---|---|---|
| Caregiver Discipline Strategies | 1.9 ± 1.3 | 2.0 ± 1.4 | 2.1 ± 1.4 |
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.
| score on a scale | Usual care including ROR | ROR plus text messages | ROR plus text messages plus connection to community resources |
|---|---|---|---|
| 9-month follow-up | 21.7 ± 3.9 | 21.6 ± 3.1 | 22.1 ± 3.3 |
| 18-month follow-up | 20.1 ± 3.4 | 20.1 ± 2.9 | 19.8 ± 2.9 |
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.
| score on a scale | Usual care including ROR | ROR plus text messages | ROR plus text messages plus connection to community resources |
|---|---|---|---|
| Baseline | 2.6 ± 1.2 | 2.5 ± 1.2 | 2.7 ± 1.2 |
| 9-month follow-up | 2.4 ± 1.2 | 2.3 ± 1.1 | 2.5 ± 1.2 |
| 18-month follow-up | 2.4 ± 1.0 | 2.4 ± 1.0 | 2.5 ± 1.1 |
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.
| score on a scale | Usual care including ROR | ROR plus text messages | ROR plus text messages plus connection to community resources |
|---|---|---|---|
| Baseline | 5.8 ± 1.9 | 5.7 ± 1.9 | 5.5 ± 2.1 |
| 9-month follow-up | 5.3 ± 2.0 | 5.3 ± 2.1 | 5.4 ± 2.0 |
| 18-month follow-up | 4.9 ± 2.1 | 5.1 ± 2.1 | 4.8 ± 2.1 |
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.
| score on a scale | Usual care including ROR | ROR plus text messages | ROR plus text messages plus connection to community resources |
|---|---|---|---|
| Baseline | 2.6 ± 1.1 | 2.7 ± 2.0 | 2.7 ± 1.1 |
| 9-month follow-up | 2.8 ± 1.2 | 2.6 ± 1.2 | 2.8 ± 1.2 |
| 18-month follow-up | 2.8 ± 1.2 | 2.7 ± 1.2 | 2.9 ± 1.2 |
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.
| score on a scale | Usual care including ROR | ROR plus text messages | ROR plus text messages plus connection to community resources |
|---|---|---|---|
| Baseline | 34.4 ± 7.9 | 35.1 ± 7.8 | 34.8 ± 7.5 |
| 9-month follow-up | 34.9 ± 7.7 | 35.8 ± 8.6 | 34.7 ± 8.0 |
| 18-month follow-up | 34.9 ± 7.5 | 34.5 ± 8.4 | 34.9 ± 7.6 |
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.
| score on a scale | Usual care including ROR | ROR plus text messages | ROR plus text messages plus connection to community resources |
|---|---|---|---|
| Baseline | 4.9 ± 3.2 | 4.7 ± 2.7 | 4.6 ± 2.9 |
| 9-month follow-up | 5.2 ± 2.6 | 5.1 ± 2.7 | 4.9 ± 2.6 |
| 18-month follow-up | 5.2 ± 2.2 | 5.1 ± 2.3 | 4.9 ± 2.2 |
Caregiver's report of receipt of literacy promotion components during their previous healthcare visit.
| Participants | Usual care including ROR | ROR plus text messages | ROR plus text messages plus connection to community resources |
|---|---|---|---|
| Baseline 0 components | 51 | 57 | 63 |
| Baseline 1 component | 52 | 53 | 42 |
| Baseline 2 components | 73 | 73 | 72 |
| Baseline 3 components | 33 | 27 | 34 |
| 9-month follow-up 0 componenets | 64 | 57 | 56 |
| 9-month follow up 1 component | 36 | 40 | 48 |
| 9-month follow-up 2 components | 45 | 52 | 46 |
| 9-month follow-up 3 components | 23 | 24 | 28 |
| 18-month follow-up 0 components | 70 | 51 | 61 |
| 18-month follow-up 1 component | 31 | 50 | 51 |
| 18-month follow-up 2 components | 45 | 36 | 42 |
| 18-month follow-up 3 components | 24 | 32 | 24 |
Observation of parent-child interactions during shared reading and free play; observations will be coded based on DialogPR items
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual care including ROR | — | — | — |
| ROR plus text messages | — | — | — |
| ROR plus text messages plus connection to community resources | — | — | — |
The overall number of baseline participants represents the number of caregiver/child dyads in each arm.
| Age, Continuous(years) | Usual Care Including ROR | ROR Plus Text Messages | ROR Plus Text Messages Plus Connection to Community Resources | Total |
|---|---|---|---|---|
| Mean | 30.4 ± 6.4 | 31.5 ± 6.7 | 30.7 ± 5.9 | 31.0 ± 6.3 |
| Age, Continuous(months) | Usual Care Including ROR | ROR Plus Text Messages | ROR Plus Text Messages Plus Connection to Community Resources | Total |
|---|---|---|---|---|
| Mean | 7.8 ± 1.4 | 8.0 ± 1.5 | 8.1 ± 1.5 | 8.0 ± 1.5 |
| Sex: Female, Male(Participants) | Usual Care Including ROR | ROR Plus Text Messages | ROR Plus Text Messages Plus Connection to Community Resources | Total |
|---|---|---|---|---|
| Female | 205 | 207 | 204 | 616 |
| Male | 4 | 3 | 7 | 14 |
| Sex: Female, Male(Participants) | Usual Care Including ROR | ROR Plus Text Messages | ROR Plus Text Messages Plus Connection to Community Resources | Total |
|---|---|---|---|---|
| Female | 92 | 110 | 117 | 319 |
| Male | 117 | 100 | 94 | 311 |
| Ethnicity (NIH/OMB)(Participants) | Usual Care Including ROR | ROR Plus Text Messages | ROR Plus Text Messages Plus Connection to Community Resources | Total |
|---|---|---|---|---|
| Hispanic or Latino | 209 | 210 | 211 | 630 |
| Not Hispanic or Latino | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Caregiver's Self-reported Rating of Ability to Speak English(Participants) | Usual Care Including ROR | ROR Plus Text Messages | ROR Plus Text Messages Plus Connection to Community Resources | Total |
|---|---|---|---|---|
| Speaks Very Well | 25 | 25 | 27 | 77 |
| Speaks Well | 29 | 51 | 29 | 109 |
| Speaks Not Well | 78 | 71 | 81 | 230 |
| Speaks Not at All | 76 | 62 | 74 | 212 |
| Missing | 1 | 1 | 0 | 2 |
| Caregiver's Highest Level of Education(Participants) | Usual Care Including ROR | ROR Plus Text Messages | ROR Plus Text Messages Plus Connection to Community Resources | Total |
|---|---|---|---|---|
| < High School | 35 | 33 | 36 | 104 |
| Some High School | 40 | 29 | 41 | 110 |
| High School Graduate | 80 | 95 | 75 | 250 |
| Some College | 26 | 26 | 25 | 77 |
| ≥ College graduate | 28 | 26 | 34 | 88 |
| Missing | 0 | 1 | 0 | 1 |
| Caregiver Health Literacy Score(units on a scale) | Usual Care Including ROR | ROR Plus Text Messages | ROR Plus Text Messages Plus Connection to Community Resources | Total |
|---|---|---|---|---|
| Mean | 15.7 ± 2.7 | 15.4 ± 2.8 | 15.9 ± 1.8 | 15.7 ± 2.5 |
7 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Deidentified quantitative data and associated documentation may be made available to users conducting non-profit research under a written data-sharing agreement.
Supporting information: 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.
Ran from Nov 2020 to primary completion in Dec 2024, 49 months.
Results were first posted in Nov 2025, 10 months after primary completion.
Of 140 non-industry interventional studies with no phase under Child Behavior, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 42. This study's 49 months is above that.
Counting every sponsor, half of 141 studies reached it within 20 months; a quarter within 8 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Rutgers, The State University of New Jersey →