Behavior, Child, Language Development, Literacy, Parenting
Conditions
Keywords
literacy promotion, early childhood, Latino, primary care
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.
Interventions
BEHAVIORALUsual care including ROR
Usual care which includes ROR.
BEHAVIORALText messages
3 text messages per week and one interactive text per month.
BEHAVIORALConnection to community resources
Referral to a non-profit that connects families with community resources and provides families with case management.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Discipline Strategies | 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. |
| Dialogic Reading Behavior | 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. |
| Child Language Skills | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child Media Use | 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. |
| Caregiver Attitudes About Reading | 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. |
| Community Resource Participation | 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. |
| Caregiver-clinician Relationship | 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. |
| Social Needs and Stress | 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. |
| Parent Stress | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| ROR Receipt | Baseline; 9-month follow up; 18-month follow up | Caregiver's report of receipt of literacy promotion components during their previous healthcare visit. |
| Observed Parent-child Interactions | 9-month follow up | Observation of parent-child interactions during shared reading and free play; observations will be coded based on DialogPR items |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from three health centers in central New Jersey between November 2020 and June 2023.
Pre-assignment details
1,129 potential participants were assessed for eligibility, and of these, 467 were excluded, and 662 met inclusion criteria and were consented. Of these 662 participants, 630 were randomized. Of the other 32 who were not randomized, 17 declined to participate and 15 lost contact.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Including ROR 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.
Usual care including ROR: Usual care which includes ROR. | 209 |
| ROR Plus Text Messages 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.
Usual care including ROR: Usual care which includes ROR.
Text messages: 3 text messages per week and one interactive text per month. | 210 |
| ROR Plus Text Messages Plus Connection to Community Resources 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.
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. | 211 |
| Total | 630 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Discontinued | 12 | 10 | 9 |
| Overall Study | Lost to Follow-up | 27 | 31 | 24 |
Baseline characteristics
| Characteristic | Usual Care Including ROR | ROR Plus Text Messages | ROR Plus Text Messages Plus Connection to Community Resources | Total |
|---|---|---|---|---|
| Age, Continuous | 7.8 months STANDARD_DEVIATION 1.4 | 8.0 months STANDARD_DEVIATION 1.5 | 8.1 months STANDARD_DEVIATION 1.5 | 8.0 months STANDARD_DEVIATION 1.5 |
| Caregiver-Clinician Relationship | 5.8 units on a scale STANDARD_DEVIATION 1.9 | 5.7 units on a scale STANDARD_DEVIATION 1.9 | 5.5 units on a scale STANDARD_DEVIATION 2.1 | 5.7 units on a scale STANDARD_DEVIATION 1.9 |
| Caregiver Health Literacy Score | 15.7 units on a scale STANDARD_DEVIATION 2.7 | 15.4 units on a scale STANDARD_DEVIATION 2.8 | 15.9 units on a scale STANDARD_DEVIATION 1.8 | 15.7 units on a scale STANDARD_DEVIATION 2.5 |
| Caregiver's Highest Level of Education ≥ College graduate | 28 Participants | 26 Participants | 34 Participants | 88 Participants |
| Caregiver's Highest Level of Education < High School | 35 Participants | 33 Participants | 36 Participants | 104 Participants |
| Caregiver's Highest Level of Education High School Graduate | 80 Participants | 95 Participants | 75 Participants | 250 Participants |
| Caregiver's Highest Level of Education Missing | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Caregiver's Highest Level of Education Some College | 26 Participants | 26 Participants | 25 Participants | 77 Participants |
| Caregiver's Highest Level of Education Some High School | 40 Participants | 29 Participants | 41 Participants | 110 Participants |
| Caregiver's Self-reported Rating of Ability to Speak English Missing | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Caregiver's Self-reported Rating of Ability to Speak English Speaks Not at All | 76 Participants | 62 Participants | 74 Participants | 212 Participants |
| Caregiver's Self-reported Rating of Ability to Speak English Speaks Not Well | 78 Participants | 71 Participants | 81 Participants | 230 Participants |
| Caregiver's Self-reported Rating of Ability to Speak English Speaks Very Well | 25 Participants | 25 Participants | 27 Participants | 77 Participants |
| Caregiver's Self-reported Rating of Ability to Speak English Speaks Well | 29 Participants | 51 Participants | 29 Participants | 109 Participants |
| Child Media Use | 4.9 units on a scale STANDARD_DEVIATION 3.2 | 4.7 units on a scale STANDARD_DEVIATION 2.7 | 4.6 units on a scale STANDARD_DEVIATION 2.9 | 4.7 units on a scale STANDARD_DEVIATION 2.9 |
| Child Social-Emotional Skills | 95.7 T-score STANDARD_DEVIATION 18.3 | 93.8 T-score STANDARD_DEVIATION 17.8 | 94.5 T-score STANDARD_DEVIATION 18.3 | 94.7 T-score STANDARD_DEVIATION 18.2 |
| Community Resource Participation | 2.6 units on a scale STANDARD_DEVIATION 1.2 | 2.5 units on a scale STANDARD_DEVIATION 1.2 | 2.7 units on a scale STANDARD_DEVIATION 1.2 | 2.6 units on a scale STANDARD_DEVIATION 1.2 |
| Economic Stress | 2.6 units on a scale STANDARD_DEVIATION 1.1 | 2.7 units on a scale STANDARD_DEVIATION 2 | 2.7 units on a scale STANDARD_DEVIATION 1.1 | 2.7 units on a scale STANDARD_DEVIATION 1.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 209 Participants | 210 Participants | 211 Participants | 630 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Parent Stress | 34.4 units on a scale STANDARD_DEVIATION 7.9 | 35.1 units on a scale STANDARD_DEVIATION 7.8 | 34.8 units on a scale STANDARD_DEVIATION 7.5 | 34.8 units on a scale STANDARD_DEVIATION 7.7 |
| Reading Activities | 4.5 units on a scale STANDARD_DEVIATION 3.9 | 4.0 units on a scale STANDARD_DEVIATION 3.9 | 4.2 units on a scale STANDARD_DEVIATION 3.9 | 4.2 units on a scale STANDARD_DEVIATION 3.9 |
| Sex: Female, Male Female | 205 Participants | 207 Participants | 204 Participants | 616 Participants |
| Sex: Female, Male Male | 117 Participants | 100 Participants | 94 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
Population: Analyses for the 9-month and 18-month follow-up visits include participants who had baseline data and completed the StimQ2 at the 9-month and/or 18-month follow-up visit(s), respectively. Participants who did not participate in the 9-month follow-up were still welcome to participate in the 18-month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual care including ROR | Caregiver Cognitive Stimulation | Baseline (Reading) | 4.5 score on a scale | Standard Deviation 3.9 |
| Usual care including ROR | Caregiver Cognitive Stimulation | 9-month follow-up (Parent Verbal Responsiveness) | 5.5 score on a scale | Standard Deviation 2.3 |
| Usual care including ROR | Caregiver Cognitive Stimulation | 9-month follow-up (Reading) | 6.0 score on a scale | Standard Deviation 3.8 |
| Usual care including ROR | Caregiver Cognitive Stimulation | 18-month follow-up (Reading) | 6.6 score on a scale | Standard Deviation 4.2 |
| Usual care including ROR | Caregiver Cognitive Stimulation | 18-month follow-up (Parent Verbal Responsiveness) | 6.5 score on a scale | Standard Deviation 1.9 |
| ROR plus text messages | Caregiver Cognitive Stimulation | 18-month follow-up (Reading) | 6.8 score on a scale | Standard Deviation 4 |
| ROR plus text messages | Caregiver Cognitive Stimulation | 9-month follow-up (Reading) | 6.7 score on a scale | Standard Deviation 3.5 |
| ROR plus text messages | Caregiver Cognitive Stimulation | 18-month follow-up (Parent Verbal Responsiveness) | 6.4 score on a scale | Standard Deviation 2.1 |
| ROR plus text messages | Caregiver Cognitive Stimulation | Baseline (Reading) | 4.0 score on a scale | Standard Deviation 3.9 |
| ROR plus text messages | Caregiver Cognitive Stimulation | 9-month follow-up (Parent Verbal Responsiveness) | 5.8 score on a scale | Standard Deviation 2.1 |
| ROR plus text messages plus connection to community resources | Caregiver Cognitive Stimulation | Baseline (Reading) | 4.2 score on a scale | Standard Deviation 3.9 |
| ROR plus text messages plus connection to community resources | Caregiver Cognitive Stimulation | 9-month follow-up (Parent Verbal Responsiveness) | 6.1 score on a scale | Standard Deviation 2 |
| ROR plus text messages plus connection to community resources | Caregiver Cognitive Stimulation | 18-month follow-up (Parent Verbal Responsiveness) | 6.8 score on a scale | Standard Deviation 1.9 |
| ROR plus text messages plus connection to community resources | Caregiver Cognitive Stimulation | 18-month follow-up (Reading) | 6.7 score on a scale | Standard Deviation 4.1 |
| ROR plus text messages plus connection to community resources | Caregiver Cognitive Stimulation | 9-month follow-up (Reading) | 6.1 score on a scale | Standard Deviation 3.8 |
Comparison: Analysis for the Reading Scale at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.p-value: 0.002ANOVA
Comparison: Analysis for the Reading Scale at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.p-value: 0.8ANOVA
Comparison: Analysis for the Reading Scale at the18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.p-value: 0.79ANOVA
Comparison: Analysis for the Reading Scale at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.p-value: 0.96ANOVA
Comparison: Analysis for the Parent Verbal Responsiveness Scale at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.p-value: 0.22ANOVA
Comparison: Analysis for the Parent Verbal Responsiveness Scale at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.p-value: <0.001ANOVA
Comparison: Analysis for the Parent Verbal Responsiveness Scale at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.p-value: 0.96ANOVA
Comparison: Analysis for the Parent Verbal Responsiveness Scale at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.p-value: 0.12ANOVA
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.
Time frame: 18-month follow-up
Population: Analyses include participants who had baseline data and completed the caregiver discipline strategy measure at the 18-month follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual care including ROR | Caregiver Discipline Strategies | 1.9 score on a scale | Standard Deviation 1.3 |
| ROR plus text messages | Caregiver Discipline Strategies | 2.0 score on a scale | Standard Deviation 1.4 |
| ROR plus text messages plus connection to community resources | Caregiver Discipline Strategies | 2.1 score on a scale | Standard Deviation 1.4 |
Comparison: A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.p-value: 0.78ANOVA
Comparison: A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.p-value: 0.96ANOVA
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 higher scores denote stronger skills.
Time frame: 9-month follow-up, 18-month follow-up
Population: Analyses for the 9-month and 18-month follow-up visits include participants who had baseline data and completed the MacArthur Bates Communicative Development Inventories at the 9-month and/or 18-month follow-up visit(s), respectively. Participants who did not participate in the 9-month follow-up were still welcome to participate in the 18-month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual care including ROR | Child Communicative Skills | 9-month follow-up | 12.5 score on a scale | Standard Deviation 13.7 |
| Usual care including ROR | Child Communicative Skills | 18-month follow-up | 44.5 score on a scale | Standard Deviation 32.2 |
| ROR plus text messages | Child Communicative Skills | 9-month follow-up | 13.5 score on a scale | Standard Deviation 14.4 |
| ROR plus text messages | Child Communicative Skills | 18-month follow-up | 50.4 score on a scale | Standard Deviation 30.8 |
| ROR plus text messages plus connection to community resources | Child Communicative Skills | 9-month follow-up | 15.7 score on a scale | Standard Deviation 20.9 |
| ROR plus text messages plus connection to community resources | Child Communicative Skills | 18-month follow-up | 46.6 score on a scale | Standard Deviation 32.1 |
Comparison: Analysis for 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.p-value: 0.84ANOVA
Comparison: Analysis for 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.p-value: 0.82ANOVA
Comparison: Analysis for 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.p-value: 0.001ANOVA
Comparison: Analysis for 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.p-value: 0.16ANOVA
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. 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
Population: Participants include those who had baseline data and completed the EOWPVT at the 18-month follow-up. The EOWPVT was only administered at the 18-month follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual care including ROR | Child Language Skills | 2.1 score on a scale | Standard Deviation 4.2 |
| ROR plus text messages | Child Language Skills | 2.3 score on a scale | Standard Deviation 4.2 |
| ROR plus text messages plus connection to community resources | Child Language Skills | 2.6 score on a scale | Standard Deviation 4.4 |
Comparison: A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.p-value: 0.64ANOVA
Comparison: A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.p-value: 0.46ANOVA
Primary
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
Population: Analyses for the 9-month and 18-month follow-up visits include participants who had baseline data and completed the DECA at the 9-month and/or 18-month follow-up visit(s), respectively. Participants who did not participate in the 9-month follow-up were still welcome to participate in the 18-month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual care including ROR | Child Social-emotional Skills | 9-month follow-up | 88.4 T-score | Standard Deviation 17.2 |
| Usual care including ROR | Child Social-emotional Skills | Baseline | 95.7 T-score | Standard Deviation 18.3 |
| Usual care including ROR | Child Social-emotional Skills | 18-month follow-up | 133.5 T-score | Standard Deviation 26.5 |
| ROR plus text messages | Child Social-emotional Skills | 9-month follow-up | 87.9 T-score | Standard Deviation 19.2 |
| ROR plus text messages | Child Social-emotional Skills | Baseline | 93.8 T-score | Standard Deviation 17.8 |
| ROR plus text messages | Child Social-emotional Skills | 18-month follow-up | 138.4 T-score | Standard Deviation 28.4 |
| ROR plus text messages plus connection to community resources | Child Social-emotional Skills | Baseline | 94.5 T-score | Standard Deviation 18.3 |
| ROR plus text messages plus connection to community resources | Child Social-emotional Skills | 18-month follow-up | 140.6 T-score | Standard Deviation 24.6 |
| ROR plus text messages plus connection to community resources | Child Social-emotional Skills | 9-month follow-up | 91.4 T-score | Standard Deviation 18.9 |
Comparison: Analysis for 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.p-value: 0.93ANOVA
Comparison: Analysis for 9-month follow-up, A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.p-value: 0.04ANOVA
Comparison: Analysis for 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.p-value: 0.08ANOVA
Comparison: Analysis for 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.p-value: 0.03ANOVA
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.
Time frame: 9-month follow-up
Population: Analyses for the 9-month visit include participants who had baseline data and completed the DialogPR at the 9-month visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual care including ROR | Dialogic Reading Behavior | 16.7 score on a scale | Standard Deviation 10 |
| ROR plus text messages | Dialogic Reading Behavior | 18.1 score on a scale | Standard Deviation 8.8 |
| ROR plus text messages plus connection to community resources | Dialogic Reading Behavior | 17.3 score on a scale | Standard Deviation 10.1 |
Comparison: A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.p-value: 0.78ANOVA
Comparison: A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.p-value: 0.96ANOVA
Secondary
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
Population: Analyses for the 9-month and 18-month follow-up visits include participants who had baseline data and completed the Parent Reading Belief Inventory (positive affect scale) at the 9-month and/or 18-month follow-up visit(s), respectively. Participants who did not participate in the 9-month follow-up were still welcome to participate in the 18-month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual care including ROR | Caregiver Attitudes About Reading | 18-month follow-up | 20.1 score on a scale | Standard Deviation 3.4 |
| Usual care including ROR | Caregiver Attitudes About Reading | 9-month follow-up | 21.7 score on a scale | Standard Deviation 3.9 |
| ROR plus text messages | Caregiver Attitudes About Reading | 18-month follow-up | 20.1 score on a scale | Standard Deviation 2.9 |
| ROR plus text messages | Caregiver Attitudes About Reading | 9-month follow-up | 21.6 score on a scale | Standard Deviation 3.1 |
| ROR plus text messages plus connection to community resources | Caregiver Attitudes About Reading | 18-month follow-up | 19.8 score on a scale | Standard Deviation 2.9 |
| ROR plus text messages plus connection to community resources | Caregiver Attitudes About Reading | 9-month follow-up | 22.1 score on a scale | Standard Deviation 3.3 |
Comparison: Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.p-value: 0.06ANOVA
Comparison: Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.p-value: 0.8ANOVA
Comparison: Analysis at the 18-month follow-up.~\\A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.p-value: 0.81ANOVA
Comparison: Analysis at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.p-value: 0.08ANOVA
Secondary
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
Population: Analyses for the 9-month and 18-month follow-up visits include participants who had baseline data and completed the Physician-Parent Communication Survey at the 9-month and/or 18-month follow-up visit(s), respectively. Participants who did not participate in the 9-month follow-up were still welcome to participate in the 18-month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual care including ROR | Caregiver-clinician Relationship | Baseline | 5.8 score on a scale | Standard Deviation 1.9 |
| Usual care including ROR | Caregiver-clinician Relationship | 18-month follow-up | 4.9 score on a scale | Standard Deviation 2.1 |
| Usual care including ROR | Caregiver-clinician Relationship | 9-month follow-up | 5.3 score on a scale | Standard Deviation 2 |
| ROR plus text messages | Caregiver-clinician Relationship | 18-month follow-up | 5.1 score on a scale | Standard Deviation 2.1 |
| ROR plus text messages | Caregiver-clinician Relationship | 9-month follow-up | 5.3 score on a scale | Standard Deviation 2.1 |
| ROR plus text messages | Caregiver-clinician Relationship | Baseline | 5.7 score on a scale | Standard Deviation 1.9 |
| ROR plus text messages plus connection to community resources | Caregiver-clinician Relationship | 9-month follow-up | 5.4 score on a scale | Standard Deviation 2 |
| ROR plus text messages plus connection to community resources | Caregiver-clinician Relationship | Baseline | 5.5 score on a scale | Standard Deviation 2.1 |
| ROR plus text messages plus connection to community resources | Caregiver-clinician Relationship | 18-month follow-up | 4.8 score on a scale | Standard Deviation 2.1 |
Comparison: Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.p-value: 0.19ANOVA
Comparison: Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.p-value: 0.18ANOVA
Comparison: Analysis at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.p-value: 0.18ANOVA
Comparison: Analysis at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.p-value: 0.45ANOVA
Secondary
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
Population: Analyses for the 9-month and 18-month follow-up visits include participants who had baseline data and completed the ScreenQ at the 9-month and/or 18-month follow-up visit(s), respectively. Participants who did not participate in the 9-month follow-up were still welcome to participate in the 18-month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual care including ROR | Child Media Use | 9-month follow-up | 5.2 score on a scale | Standard Deviation 2.6 |
| Usual care including ROR | Child Media Use | Baseline | 4.9 score on a scale | Standard Deviation 3.2 |
| Usual care including ROR | Child Media Use | 18-month follow-up | 5.2 score on a scale | Standard Deviation 2.2 |
| ROR plus text messages | Child Media Use | 9-month follow-up | 5.1 score on a scale | Standard Deviation 2.7 |
| ROR plus text messages | Child Media Use | Baseline | 4.7 score on a scale | Standard Deviation 2.7 |
| ROR plus text messages | Child Media Use | 18-month follow-up | 5.1 score on a scale | Standard Deviation 2.3 |
| ROR plus text messages plus connection to community resources | Child Media Use | Baseline | 4.6 score on a scale | Standard Deviation 2.9 |
| ROR plus text messages plus connection to community resources | Child Media Use | 18-month follow-up | 4.9 score on a scale | Standard Deviation 2.2 |
| ROR plus text messages plus connection to community resources | Child Media Use | 9-month follow-up | 4.9 score on a scale | Standard Deviation 2.6 |
Comparison: Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.p-value: 0.99ANOVA
Comparison: Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.p-value: 0.07ANOVA
Comparison: Analysis at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.p-value: 0.41ANOVA
Comparison: Analysis at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.p-value: 0.03ANOVA
Secondary
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
Population: Analyses for the 9-month and 18-month follow-up visits include participants who had baseline data and completed the SIPP at the 9-month and/or 18-month follow-up visit(s), respectively. Participants who did not participate in the 9-month follow-up were still welcome to participate in the 18-month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual care including ROR | Community Resource Participation | 9-month follow-up | 2.4 score on a scale | Standard Deviation 1.2 |
| Usual care including ROR | Community Resource Participation | Baseline | 2.6 score on a scale | Standard Deviation 1.2 |
| Usual care including ROR | Community Resource Participation | 18-month follow-up | 2.4 score on a scale | Standard Deviation 1 |
| ROR plus text messages | Community Resource Participation | 9-month follow-up | 2.3 score on a scale | Standard Deviation 1.1 |
| ROR plus text messages | Community Resource Participation | Baseline | 2.5 score on a scale | Standard Deviation 1.2 |
| ROR plus text messages | Community Resource Participation | 18-month follow-up | 2.4 score on a scale | Standard Deviation 1 |
| ROR plus text messages plus connection to community resources | Community Resource Participation | Baseline | 2.7 score on a scale | Standard Deviation 1.2 |
| ROR plus text messages plus connection to community resources | Community Resource Participation | 18-month follow-up | 2.5 score on a scale | Standard Deviation 1.1 |
| ROR plus text messages plus connection to community resources | Community Resource Participation | 9-month follow-up | 2.5 score on a scale | Standard Deviation 1.2 |
Comparison: Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.p-value: 0.07ANOVA
Comparison: Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.p-value: 0.91ANOVA
Comparison: Analysis at the18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.p-value: 0.39ANOVA
Comparison: Analysis at the 18-month follow-up.~\\A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.p-value: 0.1ANOVA
Secondary
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
Population: Analyses for the 9-month and 18-month follow-up visits include participants who had baseline data and completed the Parental Stress Scale at the 9-month and/or 18-month follow-up visit(s), respectively. Participants who did not participate in the 9-month follow-up were still welcome to participate in the 18-month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual care including ROR | Parent Stress | 9-month follow-up | 34.9 score on a scale | Standard Deviation 7.7 |
| Usual care including ROR | Parent Stress | Baseline | 34.4 score on a scale | Standard Deviation 7.9 |
| Usual care including ROR | Parent Stress | 18-month follow-up | 34.9 score on a scale | Standard Deviation 7.5 |
| ROR plus text messages | Parent Stress | 9-month follow-up | 35.8 score on a scale | Standard Deviation 8.6 |
| ROR plus text messages | Parent Stress | Baseline | 35.1 score on a scale | Standard Deviation 7.8 |
| ROR plus text messages | Parent Stress | 18-month follow-up | 34.5 score on a scale | Standard Deviation 8.4 |
| ROR plus text messages plus connection to community resources | Parent Stress | Baseline | 34.8 score on a scale | Standard Deviation 7.5 |
| ROR plus text messages plus connection to community resources | Parent Stress | 18-month follow-up | 34.9 score on a scale | Standard Deviation 7.6 |
| ROR plus text messages plus connection to community resources | Parent Stress | 9-month follow-up | 34.7 score on a scale | Standard Deviation 8 |
Comparison: Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.p-value: 0.87ANOVA
Comparison: Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.p-value: 0.14ANOVA
Comparison: Analysis at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.p-value: 0.007ANOVA
Comparison: Analysis at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.p-value: 0.34ANOVA
Secondary
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
Population: Analyses for the 9-month and 18-month follow-up visits include participants who had baseline data and completed the LINK at the 9-month and/or 18-month follow-up visit(s), respectively. Participants who did not participate in the 9-month follow-up were still welcome to participate in the 18-month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual care including ROR | Social Needs and Stress | 9-month follow-up | 2.8 score on a scale | Standard Deviation 1.2 |
| Usual care including ROR | Social Needs and Stress | Baseline | 2.6 score on a scale | Standard Deviation 1.1 |
| Usual care including ROR | Social Needs and Stress | 18-month follow-up | 2.8 score on a scale | Standard Deviation 1.2 |
| ROR plus text messages | Social Needs and Stress | 9-month follow-up | 2.6 score on a scale | Standard Deviation 1.2 |
| ROR plus text messages | Social Needs and Stress | Baseline | 2.7 score on a scale | Standard Deviation 2 |
| ROR plus text messages | Social Needs and Stress | 18-month follow-up | 2.7 score on a scale | Standard Deviation 1.2 |
| ROR plus text messages plus connection to community resources | Social Needs and Stress | Baseline | 2.7 score on a scale | Standard Deviation 1.1 |
| ROR plus text messages plus connection to community resources | Social Needs and Stress | 18-month follow-up | 2.9 score on a scale | Standard Deviation 1.2 |
| ROR plus text messages plus connection to community resources | Social Needs and Stress | 9-month follow-up | 2.8 score on a scale | Standard Deviation 1.2 |
Comparison: Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.p-value: <0.001ANOVA
Comparison: Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.p-value: 0.68ANOVA
Comparison: Analysis at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.p-value: 0.16ANOVA
Comparison: Analysis at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.p-value: 0.39ANOVA
Other Pre-specified
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
Other Pre-specified
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
Population: Analyses for the 9-month and 18-month follow-up visits include participants who had baseline data and completed the 9-month and/or 18-month follow-up visit(s), respectively. Participants who did not participate in the 9-month follow-up were still welcome to participate in the 18-month follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual care including ROR | ROR Receipt | 9-month follow up 1 component | 36 Participants |
| Usual care including ROR | ROR Receipt | 9-month follow-up 2 components | 45 Participants |
| Usual care including ROR | ROR Receipt | 9-month follow-up 3 components | 23 Participants |
| Usual care including ROR | ROR Receipt | 18-month follow-up 0 components | 70 Participants |
| Usual care including ROR | ROR Receipt | 18-month follow-up 1 component | 31 Participants |
| Usual care including ROR | ROR Receipt | 18-month follow-up 2 components | 45 Participants |
| Usual care including ROR | ROR Receipt | 18-month follow-up 3 components | 24 Participants |
| Usual care including ROR | ROR Receipt | Baseline 0 components | 51 Participants |
| Usual care including ROR | ROR Receipt | Baseline 1 component | 52 Participants |
| Usual care including ROR | ROR Receipt | Baseline 2 components | 73 Participants |
| Usual care including ROR | ROR Receipt | Baseline 3 components | 33 Participants |
| Usual care including ROR | ROR Receipt | 9-month follow-up 0 componenets | 64 Participants |
| ROR plus text messages | ROR Receipt | 9-month follow-up 0 componenets | 57 Participants |
| ROR plus text messages | ROR Receipt | 9-month follow up 1 component | 40 Participants |
| ROR plus text messages | ROR Receipt | 18-month follow-up 3 components | 32 Participants |
| ROR plus text messages | ROR Receipt | Baseline 1 component | 53 Participants |
| ROR plus text messages | ROR Receipt | 9-month follow-up 2 components | 52 Participants |
| ROR plus text messages | ROR Receipt | 18-month follow-up 2 components | 36 Participants |
| ROR plus text messages | ROR Receipt | Baseline 3 components | 27 Participants |
| ROR plus text messages | ROR Receipt | 9-month follow-up 3 components | 24 Participants |
| ROR plus text messages | ROR Receipt | Baseline 0 components | 57 Participants |
| ROR plus text messages | ROR Receipt | 18-month follow-up 1 component | 50 Participants |
| ROR plus text messages | ROR Receipt | 18-month follow-up 0 components | 51 Participants |
| ROR plus text messages | ROR Receipt | Baseline 2 components | 73 Participants |
| ROR plus text messages plus connection to community resources | ROR Receipt | 18-month follow-up 0 components | 61 Participants |
| ROR plus text messages plus connection to community resources | ROR Receipt | 18-month follow-up 1 component | 51 Participants |
| ROR plus text messages plus connection to community resources | ROR Receipt | Baseline 2 components | 72 Participants |
| ROR plus text messages plus connection to community resources | ROR Receipt | 18-month follow-up 2 components | 42 Participants |
| ROR plus text messages plus connection to community resources | ROR Receipt | 18-month follow-up 3 components | 24 Participants |
| ROR plus text messages plus connection to community resources | ROR Receipt | Baseline 0 components | 63 Participants |
| ROR plus text messages plus connection to community resources | ROR Receipt | Baseline 3 components | 34 Participants |
| ROR plus text messages plus connection to community resources | ROR Receipt | 9-month follow up 1 component | 48 Participants |
| ROR plus text messages plus connection to community resources | ROR Receipt | 9-month follow-up 2 components | 46 Participants |
| ROR plus text messages plus connection to community resources | ROR Receipt | Baseline 1 component | 42 Participants |
| ROR plus text messages plus connection to community resources | ROR Receipt | 9-month follow-up 3 components | 28 Participants |
| ROR plus text messages plus connection to community resources | ROR Receipt | 9-month follow-up 0 componenets | 56 Participants |