Trial Outcomes & Findings for Literacy Promotion for Latinos Study (NCT NCT04609553)

Last Updated: 2025-12-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

662 participants

Primary outcome timeframe

18-month follow-up

Results posted on

2025-12-09

Participant Flow

Participants were recruited from three health centers in central New Jersey between November 2020 and June 2023.

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.

Participant milestones

Participant milestones
Measure	Usual care including ROR Literacy promotion is a pediatric standard of care. Participants in this group received usual care that includes ROR, a primary care literacy promotion intervention. Usual care including ROR: Usual care which includes ROR.	ROR plus text messages In addition to ROR, participants received 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.	ROR plus text messages plus connection to community resources In addition to ROR and text messages, participants were 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.
Overall Study STARTED	209	210	211
Overall Study 9-month follow up	168	173	178
Overall Study COMPLETED	170	169	178
Overall Study NOT COMPLETED	39	41	33

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual care including ROR Literacy promotion is a pediatric standard of care. Participants in this group received usual care that includes ROR, a primary care literacy promotion intervention. Usual care including ROR: Usual care which includes ROR.	ROR plus text messages In addition to ROR, participants received 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.	ROR plus text messages plus connection to community resources In addition to ROR and text messages, participants were 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.
Overall Study Lost to Follow-up	27	31	24
Overall Study Discontinued	12	10	9

Baseline Characteristics

Literacy Promotion for Latinos Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care Including ROR n=209 Participants 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.	ROR Plus Text Messages n=210 Participants 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.	ROR Plus Text Messages Plus Connection to Community Resources n=211 Participants 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.	Total n=630 Participants Total of all reporting groups
Age, Continuous	7.8 months STANDARD_DEVIATION 1.4 • n=4 Participants	8.0 months STANDARD_DEVIATION 1.5 • n=50 Participants	8.1 months STANDARD_DEVIATION 1.5 • n=518 Participants	8.0 months STANDARD_DEVIATION 1.5 • n=175 Participants
Sex: Female, Male Female	92 Participants n=4 Participants	110 Participants n=50 Participants	117 Participants n=518 Participants	319 Participants n=175 Participants
Sex: Female, Male Male	117 Participants n=4 Participants	100 Participants n=50 Participants	94 Participants n=518 Participants	311 Participants n=175 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	209 Participants n=4 Participants	210 Participants n=50 Participants	211 Participants n=518 Participants	630 Participants n=175 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=518 Participants	0 Participants n=175 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=518 Participants	0 Participants n=175 Participants
Caregiver's Self-reported Rating of Ability to Speak English Speaks Very Well	25 Participants n=4 Participants	25 Participants n=50 Participants	27 Participants n=518 Participants	77 Participants n=175 Participants
Caregiver's Self-reported Rating of Ability to Speak English Speaks Well	29 Participants n=4 Participants	51 Participants n=50 Participants	29 Participants n=518 Participants	109 Participants n=175 Participants
Caregiver's Self-reported Rating of Ability to Speak English Speaks Not Well	78 Participants n=4 Participants	71 Participants n=50 Participants	81 Participants n=518 Participants	230 Participants n=175 Participants
Caregiver's Self-reported Rating of Ability to Speak English Speaks Not at All	76 Participants n=4 Participants	62 Participants n=50 Participants	74 Participants n=518 Participants	212 Participants n=175 Participants
Caregiver's Self-reported Rating of Ability to Speak English Missing	1 Participants n=4 Participants	1 Participants n=50 Participants	0 Participants n=518 Participants	2 Participants n=175 Participants
Caregiver's Highest Level of Education < High School	35 Participants n=4 Participants	33 Participants n=50 Participants	36 Participants n=518 Participants	104 Participants n=175 Participants
Caregiver's Highest Level of Education Some High School	40 Participants n=4 Participants	29 Participants n=50 Participants	41 Participants n=518 Participants	110 Participants n=175 Participants
Caregiver's Highest Level of Education High School Graduate	80 Participants n=4 Participants	95 Participants n=50 Participants	75 Participants n=518 Participants	250 Participants n=175 Participants
Caregiver's Highest Level of Education Some College	26 Participants n=4 Participants	26 Participants n=50 Participants	25 Participants n=518 Participants	77 Participants n=175 Participants
Caregiver's Highest Level of Education ≥ College graduate	28 Participants n=4 Participants	26 Participants n=50 Participants	34 Participants n=518 Participants	88 Participants n=175 Participants
Caregiver's Highest Level of Education Missing	0 Participants n=4 Participants	1 Participants n=50 Participants	0 Participants n=518 Participants	1 Participants n=175 Participants
Child Media Use	4.9 units on a scale STANDARD_DEVIATION 3.2 • n=4 Participants	4.7 units on a scale STANDARD_DEVIATION 2.7 • n=50 Participants	4.6 units on a scale STANDARD_DEVIATION 2.9 • n=518 Participants	4.7 units on a scale STANDARD_DEVIATION 2.9 • n=175 Participants
Caregiver Health Literacy Score	15.7 units on a scale STANDARD_DEVIATION 2.7 • n=4 Participants	15.4 units on a scale STANDARD_DEVIATION 2.8 • n=50 Participants	15.9 units on a scale STANDARD_DEVIATION 1.8 • n=518 Participants	15.7 units on a scale STANDARD_DEVIATION 2.5 • n=175 Participants
Child Social-Emotional Skills	95.7 T-score STANDARD_DEVIATION 18.3 • n=4 Participants	93.8 T-score STANDARD_DEVIATION 17.8 • n=50 Participants	94.5 T-score STANDARD_DEVIATION 18.3 • n=518 Participants	94.7 T-score STANDARD_DEVIATION 18.2 • n=175 Participants
Reading Activities	4.5 units on a scale STANDARD_DEVIATION 3.9 • n=4 Participants	4.0 units on a scale STANDARD_DEVIATION 3.9 • n=50 Participants	4.2 units on a scale STANDARD_DEVIATION 3.9 • n=518 Participants	4.2 units on a scale STANDARD_DEVIATION 3.9 • n=175 Participants
Community Resource Participation	2.6 units on a scale STANDARD_DEVIATION 1.2 • n=4 Participants	2.5 units on a scale STANDARD_DEVIATION 1.2 • n=50 Participants	2.7 units on a scale STANDARD_DEVIATION 1.2 • n=518 Participants	2.6 units on a scale STANDARD_DEVIATION 1.2 • n=175 Participants
Caregiver-Clinician Relationship	5.8 units on a scale STANDARD_DEVIATION 1.9 • n=4 Participants	5.7 units on a scale STANDARD_DEVIATION 1.9 • n=50 Participants	5.5 units on a scale STANDARD_DEVIATION 2.1 • n=518 Participants	5.7 units on a scale STANDARD_DEVIATION 1.9 • n=175 Participants
Economic Stress	2.6 units on a scale STANDARD_DEVIATION 1.1 • n=4 Participants	2.7 units on a scale STANDARD_DEVIATION 2.0 • n=50 Participants	2.7 units on a scale STANDARD_DEVIATION 1.1 • n=518 Participants	2.7 units on a scale STANDARD_DEVIATION 1.1 • n=175 Participants
Parent Stress	34.4 units on a scale STANDARD_DEVIATION 7.9 • n=4 Participants	35.1 units on a scale STANDARD_DEVIATION 7.8 • n=50 Participants	34.8 units on a scale STANDARD_DEVIATION 7.5 • n=518 Participants	34.8 units on a scale STANDARD_DEVIATION 7.7 • n=175 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual care including ROR n=168 Participants 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.	ROR plus text messages n=163 Participants 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.	ROR plus text messages plus connection to community resources n=173 Participants 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.
Child Language Skills	2.1 score on a scale Standard Deviation 4.2	2.3 score on a scale Standard Deviation 4.2	2.6 score on a scale Standard Deviation 4.4

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Usual care including ROR n=194 Participants 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.	ROR plus text messages n=193 Participants 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.	ROR plus text messages plus connection to community resources n=201 Participants 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.
Child Communicative Skills 9-month follow-up	12.5 score on a scale Standard Deviation 13.7	13.5 score on a scale Standard Deviation 14.4	15.7 score on a scale Standard Deviation 20.9
Child Communicative Skills 18-month follow-up	44.5 score on a scale Standard Deviation 32.2	50.4 score on a scale Standard Deviation 30.8	46.6 score on a scale Standard Deviation 32.1

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Usual care including ROR n=207 Participants 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.	ROR plus text messages n=208 Participants 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.	ROR plus text messages plus connection to community resources n=209 Participants 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.
Child Social-emotional Skills Baseline	95.7 T-score Standard Deviation 18.3	93.8 T-score Standard Deviation 17.8	94.5 T-score Standard Deviation 18.3
Child Social-emotional Skills 9-month follow-up	88.4 T-score Standard Deviation 17.2	87.9 T-score Standard Deviation 19.2	91.4 T-score Standard Deviation 18.9
Child Social-emotional Skills 18-month follow-up	133.5 T-score Standard Deviation 26.5	138.4 T-score Standard Deviation 28.4	140.6 T-score Standard Deviation 24.6

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Usual care including ROR n=209 Participants 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.	ROR plus text messages n=210 Participants 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.	ROR plus text messages plus connection to community resources n=211 Participants 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.
Caregiver Cognitive Stimulation Baseline (Reading)	4.5 score on a scale Standard Deviation 3.9	4.0 score on a scale Standard Deviation 3.9	4.2 score on a scale Standard Deviation 3.9
Caregiver Cognitive Stimulation 9-month follow-up (Reading)	6.0 score on a scale Standard Deviation 3.8	6.7 score on a scale Standard Deviation 3.5	6.1 score on a scale Standard Deviation 3.8
Caregiver Cognitive Stimulation 18-month follow-up (Reading)	6.6 score on a scale Standard Deviation 4.2	6.8 score on a scale Standard Deviation 4.0	6.7 score on a scale Standard Deviation 4.1
Caregiver Cognitive Stimulation 9-month follow-up (Parent Verbal Responsiveness)	5.5 score on a scale Standard Deviation 2.3	5.8 score on a scale Standard Deviation 2.1	6.1 score on a scale Standard Deviation 2.0
Caregiver Cognitive Stimulation 18-month follow-up (Parent Verbal Responsiveness)	6.5 score on a scale Standard Deviation 1.9	6.4 score on a scale Standard Deviation 2.1	6.8 score on a scale Standard Deviation 1.9

PRIMARY outcome

Timeframe: 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.

The DialogPR is a caregiver report measure of shared reading quality. Score range from 0 to 30 with higher scores indicating more interactive reading.

Outcome measures

Outcome measures
Measure	Usual care including ROR n=168 Participants 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.	ROR plus text messages n=171 Participants 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.	ROR plus text messages plus connection to community resources n=178 Participants 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.
Dialogic Reading Behavior	16.7 score on a scale Standard Deviation 10.0	18.1 score on a scale Standard Deviation 8.8	17.3 score on a scale Standard Deviation 10.1

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Usual care including ROR n=169 Participants 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.	ROR plus text messages n=169 Participants 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.	ROR plus text messages plus connection to community resources n=178 Participants 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.
Caregiver Discipline Strategies	1.9 score on a scale Standard Deviation 1.3	2.0 score on a scale Standard Deviation 1.4	2.1 score on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Usual care including ROR n=181 Participants 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.	ROR plus text messages n=176 Participants 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.	ROR plus text messages plus connection to community resources n=187 Participants 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.
Caregiver Attitudes About Reading 18-month follow-up	20.1 score on a scale Standard Deviation 3.4	20.1 score on a scale Standard Deviation 2.9	19.8 score on a scale Standard Deviation 2.9
Caregiver Attitudes About Reading 9-month follow-up	21.7 score on a scale Standard Deviation 3.9	21.6 score on a scale Standard Deviation 3.1	22.1 score on a scale Standard Deviation 3.3

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Usual care including ROR n=209 Participants 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.	ROR plus text messages n=210 Participants 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.	ROR plus text messages plus connection to community resources n=211 Participants 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.
Community Resource Participation Baseline	2.6 score on a scale Standard Deviation 1.2	2.5 score on a scale Standard Deviation 1.2	2.7 score on a scale Standard Deviation 1.2
Community Resource Participation 9-month follow-up	2.4 score on a scale Standard Deviation 1.2	2.3 score on a scale Standard Deviation 1.1	2.5 score on a scale Standard Deviation 1.2
Community Resource Participation 18-month follow-up	2.4 score on a scale Standard Deviation 1.0	2.4 score on a scale Standard Deviation 1.0	2.5 score on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Usual care including ROR n=206 Participants 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.	ROR plus text messages n=210 Participants 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.	ROR plus text messages plus connection to community resources n=210 Participants 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.
Caregiver-clinician Relationship 9-month follow-up	5.3 score on a scale Standard Deviation 2.0	5.3 score on a scale Standard Deviation 2.1	5.4 score on a scale Standard Deviation 2.0
Caregiver-clinician Relationship 18-month follow-up	4.9 score on a scale Standard Deviation 2.1	5.1 score on a scale Standard Deviation 2.1	4.8 score on a scale Standard Deviation 2.1
Caregiver-clinician Relationship Baseline	5.8 score on a scale Standard Deviation 1.9	5.7 score on a scale Standard Deviation 1.9	5.5 score on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Usual care including ROR n=204 Participants 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.	ROR plus text messages n=203 Participants 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.	ROR plus text messages plus connection to community resources n=206 Participants 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.
Social Needs and Stress Baseline	2.6 score on a scale Standard Deviation 1.1	2.7 score on a scale Standard Deviation 2.0	2.7 score on a scale Standard Deviation 1.1
Social Needs and Stress 9-month follow-up	2.8 score on a scale Standard Deviation 1.2	2.6 score on a scale Standard Deviation 1.2	2.8 score on a scale Standard Deviation 1.2
Social Needs and Stress 18-month follow-up	2.8 score on a scale Standard Deviation 1.2	2.7 score on a scale Standard Deviation 1.2	2.9 score on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Usual care including ROR n=200 Participants 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.	ROR plus text messages n=206 Participants 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.	ROR plus text messages plus connection to community resources n=207 Participants 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.
Parent Stress Baseline	34.4 score on a scale Standard Deviation 7.9	35.1 score on a scale Standard Deviation 7.8	34.8 score on a scale Standard Deviation 7.5
Parent Stress 9-month follow-up	34.9 score on a scale Standard Deviation 7.7	35.8 score on a scale Standard Deviation 8.6	34.7 score on a scale Standard Deviation 8.0
Parent Stress 18-month follow-up	34.9 score on a scale Standard Deviation 7.5	34.5 score on a scale Standard Deviation 8.4	34.9 score on a scale Standard Deviation 7.6

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Usual care including ROR n=209 Participants 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.	ROR plus text messages n=210 Participants 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.	ROR plus text messages plus connection to community resources n=211 Participants 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.
Child Media Use Baseline	4.9 score on a scale Standard Deviation 3.2	4.7 score on a scale Standard Deviation 2.7	4.6 score on a scale Standard Deviation 2.9
Child Media Use 9-month follow-up	5.2 score on a scale Standard Deviation 2.6	5.1 score on a scale Standard Deviation 2.7	4.9 score on a scale Standard Deviation 2.6
Child Media Use 18-month follow-up	5.2 score on a scale Standard Deviation 2.2	5.1 score on a scale Standard Deviation 2.3	4.9 score on a scale Standard Deviation 2.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Caregiver's report of receipt of literacy promotion components during their previous healthcare visit.

Outcome measures

Outcome measures
Measure	Usual care including ROR n=209 Participants 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.	ROR plus text messages n=210 Participants 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.	ROR plus text messages plus connection to community resources n=211 Participants 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.
ROR Receipt Baseline 0 components	51 Participants	57 Participants	63 Participants
ROR Receipt Baseline 1 component	52 Participants	53 Participants	42 Participants
ROR Receipt Baseline 2 components	73 Participants	73 Participants	72 Participants
ROR Receipt Baseline 3 components	33 Participants	27 Participants	34 Participants
ROR Receipt 9-month follow-up 0 componenets	64 Participants	57 Participants	56 Participants
ROR Receipt 9-month follow up 1 component	36 Participants	40 Participants	48 Participants
ROR Receipt 9-month follow-up 2 components	45 Participants	52 Participants	46 Participants
ROR Receipt 9-month follow-up 3 components	23 Participants	24 Participants	28 Participants
ROR Receipt 18-month follow-up 0 components	70 Participants	51 Participants	61 Participants
ROR Receipt 18-month follow-up 1 component	31 Participants	50 Participants	51 Participants
ROR Receipt 18-month follow-up 2 components	45 Participants	36 Participants	42 Participants
ROR Receipt 18-month follow-up 3 components	24 Participants	32 Participants	24 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 9-month follow up

Observation of parent-child interactions during shared reading and free play; observations will be coded based on DialogPR items

Outcome measures

Outcome data not reported

Adverse Events

Usual care including ROR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ROR plus text messages

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ROR plus text messages plus connection to community resources

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manuel Jimenez, MD, MS

Rutgers University

Phone: 732-235-9300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place