ParentingNCT05760573
The Ready and Healthy for Kindergarten Study
A study testing Family Wellness Program (FWP) in people with Parenting and Language Development, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The goal of this clinical trial is to test whether a family wellness program enhances child and parenting outcomes among Latino dual language learners entering Kindergarten and their families. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Parenting, Language Development, Literacy
- What is being tested?
- Family Wellness Program (FWP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2023to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- primary caregiver of a child entering Kindergarten (4-6 years old),
- primary caregiver identifies as Hispanic/Latino/Latinx,
- family speaks Spanish at home,
- cell phone ownership,
- willing to receive text messages,
- ability to pick up program materials locally, and
- willing to accept randomization
Who cannot join
- -Individuals unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Child Health Institute
New Brunswick, New Jersey, 08901
About this study
Official title: Ready and Healthy for Kindergarten: A Primary Care Innovation to Promote a 360-degree View of Child Health
The goal of this clinical trial is to test whether a family wellness program enhances child and parenting outcomes among Latino dual language learners entering Kindergarten and their families. The main questions are: (1) To what extent does the family wellness program enhance home health and learning routines, and (2) To what extent does the family wellness program enhance child literacy, language, and social-emotional outcomes.
All participants will be asked to complete surveys and assessments.
Researchers will compare two groups: (1) Family wellness program that includes (a) 8-weekly summer sessions, (b) text messages, (c) booster sessions, and (2) usual care plus school supplies and list of resources to see if the family wellness program enhances child and parenting outcomes.
Read the detailed description
Education is a critical social determinant of health (SDOH). Latino dual language learners face large gaps in school readiness, which perpetuate inequities in academic achievement and subsequent health. Investigators developed an online family wellness program that uses anticipatory guidance on health topics intrinsically important to school readiness (e.g., nutrition, physical activity) to introduce basic language and literacy skills to Latino dual language learners, a fast- growing and particularly high-risk group, and their families. The online family wellness program was developed through a cross-sector partnership between educators and pediatric professionals and consists of parent-child workshops and reminder text messages. The program occurs during the transition into Kindergarten, a critical developmental stage, and uses promising approaches such as group structure, strategic use of technology, and partnerships. The program tightly integrates Bright Futures anticipatory guidance with the Kindergarten curriculum. During pilot testing, the investigators found that the family wellness program was feasible, well attended, and highly acceptable. The investigators now propose testing the effect of the family wellness program on child and parenting outcomes using a rigorous mixed methods and community-engaged approach. The investigators will conduct a randomized controlled trial testing the effects of the family wellness program on child language, literacy, and social-emotional outcomes as well home health and learning routines. The investigators will also conduct a mixed methods process evaluation, which will provide insight into reach and implementation as well as user experience.
- Conditions
- Parenting, Language Development, Literacy, Health Behavior
- Being tested
- Family Wellness Program (FWP)
- Keywords
- early literacy, language development, famliy literacy, bilingualism, community engagement
- Medical subject headings
- Literacy, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Wellness Program (FWP)Behavioural
The FWP will consist of the following general format: (1) 8 weekly 60-minute summer workshops; (2) 4 booster workshops throughout the year; and (3) 2-3 outreach text messages per week for 10 months.
| Study group | Role | What they receive |
|---|---|---|
| Usual care plus school supplies and resources | No intervention | This group will not be enrolled in the Family Wellness Program. They will receive usual care from their regular clinician plus a backpack with schools supplies and a list of resources. |
| Famliy Wellness Program | Experimental | This group will be enrolled in the Family Wellness Program which consists of 8 weekly parent-child workshops prior to the children entering kindergarten as well as 4 booster sessions during the child's kindergarten year. As part of the program families will receive school supplies, books and resources. Receives: Behavioral: Family Wellness Program (FWP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Home Literacy Environment Questionnaire
The home literacy environment will be assessed with the StimQ, a caregiver-reported measure of cognitive stimulation for children that includes a domain on the home literacy environment (READ scale). The READ scale includes 3 subdimensions (Book Reading Quantity, Diversity of Content, Book Reading Quality). Scores on the READ scale range from 0 to 18. Higher scores indicate more cognitive stimulation
Measured: 2 months
Home Literacy Environment Questionnaire
The home literacy environment will be assessed with the StimQ, a caregiver-reported measure of cognitive stimulation for children that includes a domain on the home literacy environment (READ scale). The READ scale includes 3 subdimensions (Book Reading Quantity, Diversity of Content, Book Reading Quality). Scores on the READ scale range from 0 to 18. Higher scores indicate more cognitive stimulation
Measured: 10 months
Parent Responsiveness Questionnaire
Parent responsiveness will be assessed with the StimQ, a caregiver-reported measure of cognitive stimulation for children that includes a domain on responsiveness (Parental Verbal Responsiveness scale). The Parental Verbal Responsiveness scale includes a subdimension on responsiveness during routines (Everyday Routines). Scores range from 0 to 8. Higher scores indicate more cognitive stimulation.
Measured: 2 months
Parent Responsiveness Questionnaire
Parent responsiveness will be assessed with the StimQ, a caregiver-reported measure of cognitive stimulation for children that includes a domain on responsiveness (Parental Verbal Responsiveness scale). The Parental Verbal Responsiveness scale includes a subdimension on responsiveness during routines (Everyday Routines). Scores range from 0 to 8. Higher scores indicate more cognitive stimulation.
Measured: 10 months
Family Health Routines Questionnaire
This is a self-report measure for family nutrition and physical activity routines, which has been validated in English and Spanish. Higher scores are consistent with healthier routines.
Measured: 2 months
Family Health Routines Questionnaire
This is a self-report measure for family nutrition and physical activity routines, which has been validated in English and Spanish. Higher scores are consistent with healthier routines.
Measured: 10 months
Caregiver Attitudes About Reading Questionnaire
The Parent Reading Belief Inventory is a caregiver reported measure of attitudes and knowledge about reading with children that includes subdimensions of teaching efficacy (scores range from 0 to 27), positive affect (scores range from 0 to 33), and knowledge (scores range from 0 to 15) available in English and Spanish. Higher scores indicate more favorable attitudes and greater knowledge.
Measured: 2 months
Caregiver Attitudes About Reading Questionnaire
The Parent Reading Belief Inventory is a caregiver reported measure of attitudes and knowledge about reading with children that includes subdimensions of teaching efficacy (scores range from 0 to 27), positive affect (scores range from 0 to 33), and knowledge (scores range from 0 to 15) available in English and Spanish. Higher scores indicate more favorable attitudes and greater knowledge.
Measured: 10 months
Child Vocabulary Assessment
Child vocabulary will be assessed using an investigator developed measure. Higher scores indicate higher skills
Measured: 2 months
Child Vocabulary Assessment
Child vocabulary will be assessed using an investigator developed measure. Higher scores indicate higher skills
Measured: 10 months
Child Language Skills Assessment
Child receptive language and listening skills will be assessed with the Receptive One Word Picture Vocabulary Test - Fourth Edition (ROWPVT-4) Spanish-Bilingual. Higher scores indicate higher skills.
Measured: 10 months
Child Literacy Skills Assessment
Literacy skills including concepts about books, story retelling, narrative thematic knowledge, letter and sound identification will be assessed using an investigator developed measure. Higher scores indicate higher skills
Measured: 2 months
Child Literacy Skills Assessment
Literacy skills including concepts about books, story retelling, narrative thematic knowledge, letter and sound identification will be assessed using an investigator developed measure. Higher scores indicate higher skills
Measured: 10 months
Child Social-emotional Development Questionnaire
Social emotional development will be measured using the Strengths and Difficulties Questionnaire (SDQ), which is a brief validated behavioral screening questionnaire for 4-17 year olds. The SDQ has been widely used in research studies. The SDQ has a total of 5 scales including the hyperactivity (scores range from 0-10) and prosocial (scores range from 0-10) scales used here. Higher scores on the hyperactivity scale indicate greater hyperactivity; higher scores on the Prosocial scale indicate greater prosocial behaviors.
Measured: 2 months
Child Social-emotional Development Questionnaire
Social emotional development will be measured using the Strengths and Difficulties Questionnaire (SDQ), which is a brief validated behavioral screening questionnaire for 4-17 year olds. The SDQ has been widely used in research studies. The SDQ has a total of 5 scales including the hyperactivity (scores range from 0-10) and prosocial (scores range from 0-10) scales used here. Higher scores on the hyperactivity scale indicate greater hyperactivity; higher scores on the Prosocial scale indicate greater prosocial behaviors.
Measured: 10 months
Secondary outcomes (6)
Child Media Use Questionnaire
The ScreenQ is a caregiver report measure of media use in children. Scores range from 0 to 26 with higher score indicating more media use.
Measured: 2 months
Child Media Use Questionnaire
The ScreenQ is a caregiver report measure of media use in children. Scores range from 0 to 26 with higher score indicating more media use.
Measured: 10 months.
Child Sleep Routines Questionnaire
Investigator developed question on sleep habits.
Measured: 2 months
Child Sleep Routines Questionnaire
Investigator developed question on sleep habits.
Measured: 10 months
Child Self-regulation Questionnaire
Using observational method by using a popular children's song to measure child's self regulation.
Measured: 2 months
Child Self-regulation Questionnaire
Using observational method by using a popular children's song to measure child's self regulation.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start15 Apr 2023
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Manuel E. Jimenez, MD, MS, Rutgers, The State University of New Jersey
- Investigators
- Manuel E Jimenez, MD, MS, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760573
- Sponsor's protocol ID
- Pro2021001575-2
- Other IDs
- R18HS028574
- Status last verified
- Apr 2026
- First submitted
- 4 Feb 2023
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified quantitative data and associated documentation may be made available to users conducting non-profit research under a written data-sharing agreement
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ready and Healthy for Kindergarten: A Primary Care Innovation to Promote a 360-degree View of Child Health
- ClinicalTrials.gov ID
- NCT05760573
- Acronym / sponsor ID
- Pro2021001575-2
- Conditions
- Parenting, Language Development, Literacy, Health Behavior
- Keywords
- early literacy, language development, famliy literacy, bilingualism, community engagement
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test whether a family wellness program enhances child and parenting outcomes among Latino dual language learners entering Kindergarten and their families. The main questions are: (1) To what extent does the family wellness program enhance home health and learning routines, and (2) To what extent does the family wellness program enhance child literacy, language, and social-emotional outcomes.
All participants will be asked to complete surveys and assessments.
Researchers will compare two groups: (1) Family wellness program that includes (a) 8-weekly summer sessions, (b) text messages, (c) booster sessions, and (2) usual care plus school supplies and list of resources to see if the family wellness program enhances child and parenting outcomes.
Detailed description
Education is a critical social determinant of health (SDOH). Latino dual language learners face large gaps in school readiness, which perpetuate inequities in academic achievement and subsequent health. Investigators developed an online family wellness program that uses anticipatory guidance on health topics intrinsically important to school readiness (e.g., nutrition, physical activity) to introduce basic language and literacy skills to Latino dual language learners, a fast- growing and particularly high-risk group, and their families. The online family wellness program was developed through a cross-sector partnership between educators and pediatric professionals and consists of parent-child workshops and reminder text messages. The program occurs during the transition into Kindergarten, a critical developmental stage, and uses promising approaches such as group structure, strategic use of technology, and partnerships. The program tightly integrates Bright Futures anticipatory guidance with the Kindergarten curriculum. During pilot testing, the investigators found that the family wellness program was feasible, well attended, and highly acceptable. The investigators now propose testing the effect of the family wellness program on child and parenting outcomes using a rigorous mixed methods and community-engaged approach. The investigators will conduct a randomized controlled trial testing the effects of the family wellness program on child language, literacy, and social-emotional outcomes as well home health and learning routines. The investigators will also conduct a mixed methods process evaluation, which will provide insight into reach and implementation as well as user experience.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care plus school supplies and resources | No intervention | –This group will not be enrolled in the Family Wellness Program. They will receive usual care from their regular clinician plus a backpack with schools supplies and a list of resources. |
| Famliy Wellness Program | Experimental | Behavioral: Family Wellness Program (FWP)This group will be enrolled in the Family Wellness Program which consists of 8 weekly parent-child workshops prior to the children entering kindergarten as well as 4 booster sessions during the child's kindergarten year. As part of the program families will receive school supplies, books and resources. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- primary caregiver of a child entering Kindergarten (4-6 years old),
- primary caregiver identifies as Hispanic/Latino/Latinx,
- family speaks Spanish at home,
- cell phone ownership,
- willing to receive text messages,
Key exclusion criteria (1 listed)
- -Individuals unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Wellness Program (FWP)The FWP will consist of the following general format: (1) 8 weekly 60-minute summer workshops; (2) 4 booster workshops throughout the year; and (3) 2-3 outreach text messages per week for 10 months. | Behavioural | Famliy Wellness Program |
Primary outcome
Home Literacy Environment Questionnaire
Time frame: 2 months
The home literacy environment will be assessed with the StimQ, a caregiver-reported measure of cognitive stimulation for children that includes a domain on the home literacy environment (READ scale). The READ scale includes 3 subdimensions (Book Reading Quantity, Diversity of Content, Book Reading Quality). Scores on the READ scale range from 0 to 18. Higher scores indicate more cognitive stimulation
Home Literacy Environment Questionnaire
Time frame: 10 months
The home literacy environment will be assessed with the StimQ, a caregiver-reported measure of cognitive stimulation for children that includes a domain on the home literacy environment (READ scale). The READ scale includes 3 subdimensions (Book Reading Quantity, Diversity of Content, Book Reading Quality). Scores on the READ scale range from 0 to 18. Higher scores indicate more cognitive stimulation
Parent Responsiveness Questionnaire
Time frame: 2 months
Parent responsiveness will be assessed with the StimQ, a caregiver-reported measure of cognitive stimulation for children that includes a domain on responsiveness (Parental Verbal Responsiveness scale). The Parental Verbal Responsiveness scale includes a subdimension on responsiveness during routines (Everyday Routines). Scores range from 0 to 8. Higher scores indicate more cognitive stimulation.
Parent Responsiveness Questionnaire
Time frame: 10 months
Parent responsiveness will be assessed with the StimQ, a caregiver-reported measure of cognitive stimulation for children that includes a domain on responsiveness (Parental Verbal Responsiveness scale). The Parental Verbal Responsiveness scale includes a subdimension on responsiveness during routines (Everyday Routines). Scores range from 0 to 8. Higher scores indicate more cognitive stimulation.
Family Health Routines Questionnaire
Time frame: 2 months
This is a self-report measure for family nutrition and physical activity routines, which has been validated in English and Spanish. Higher scores are consistent with healthier routines.
Family Health Routines Questionnaire
Time frame: 10 months
This is a self-report measure for family nutrition and physical activity routines, which has been validated in English and Spanish. Higher scores are consistent with healthier routines.
Caregiver Attitudes About Reading Questionnaire
Time frame: 2 months
The Parent Reading Belief Inventory is a caregiver reported measure of attitudes and knowledge about reading with children that includes subdimensions of teaching efficacy (scores range from 0 to 27), positive affect (scores range from 0 to 33), and knowledge (scores range from 0 to 15) available in English and Spanish. Higher scores indicate more favorable attitudes and greater knowledge.
Caregiver Attitudes About Reading Questionnaire
Time frame: 10 months
The Parent Reading Belief Inventory is a caregiver reported measure of attitudes and knowledge about reading with children that includes subdimensions of teaching efficacy (scores range from 0 to 27), positive affect (scores range from 0 to 33), and knowledge (scores range from 0 to 15) available in English and Spanish. Higher scores indicate more favorable attitudes and greater knowledge.
Child Vocabulary Assessment
Time frame: 2 months
Child vocabulary will be assessed using an investigator developed measure. Higher scores indicate higher skills
Child Vocabulary Assessment
Time frame: 10 months
Child vocabulary will be assessed using an investigator developed measure. Higher scores indicate higher skills
Child Language Skills Assessment
Time frame: 10 months
Child receptive language and listening skills will be assessed with the Receptive One Word Picture Vocabulary Test - Fourth Edition (ROWPVT-4) Spanish-Bilingual. Higher scores indicate higher skills.
Child Literacy Skills Assessment
Time frame: 2 months
Literacy skills including concepts about books, story retelling, narrative thematic knowledge, letter and sound identification will be assessed using an investigator developed measure. Higher scores indicate higher skills
Child Literacy Skills Assessment
Time frame: 10 months
Literacy skills including concepts about books, story retelling, narrative thematic knowledge, letter and sound identification will be assessed using an investigator developed measure. Higher scores indicate higher skills
Child Social-emotional Development Questionnaire
Time frame: 2 months
Social emotional development will be measured using the Strengths and Difficulties Questionnaire (SDQ), which is a brief validated behavioral screening questionnaire for 4-17 year olds. The SDQ has been widely used in research studies. The SDQ has a total of 5 scales including the hyperactivity (scores range from 0-10) and prosocial (scores range from 0-10) scales used here. Higher scores on the hyperactivity scale indicate greater hyperactivity; higher scores on the Prosocial scale indicate greater prosocial behaviors.
Child Social-emotional Development Questionnaire
Time frame: 10 months
Social emotional development will be measured using the Strengths and Difficulties Questionnaire (SDQ), which is a brief validated behavioral screening questionnaire for 4-17 year olds. The SDQ has been widely used in research studies. The SDQ has a total of 5 scales including the hyperactivity (scores range from 0-10) and prosocial (scores range from 0-10) scales used here. Higher scores on the hyperactivity scale indicate greater hyperactivity; higher scores on the Prosocial scale indicate greater prosocial behaviors.
6 secondary outcomes
Child Media Use Questionnaire
Time frame: 2 months
Child Media Use Questionnaire
Time frame: 10 months.
Child Sleep Routines Questionnaire
Time frame: 2 months
Child Sleep Routines Questionnaire
Time frame: 10 months
Child Self-regulation Questionnaire
Time frame: 2 months
Child Self-regulation Questionnaire
Time frame: 10 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: Yes. Deidentified quantitative data and associated documentation may be made available to users conducting non-profit research under a written data-sharing agreement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel E Jimenez, MD, MS principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Wellness Program (FWP) in people with Parenting and Language Development, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Home Literacy Environment Questionnaire (time frame: 2 months). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.