Clinical trial NCT05760573: The Ready and Healthy for Kindergarten Study
Official title: Ready and Healthy for Kindergarten: a Primary Care Innovation to Promote a 360-degree View of Child Health
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Parenting
Language Development
Literacy
Health Behavior
Keywords: early literacy
language development
famliy literacy
bilingualism
community engagement
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2023-03-08
Enrollment: 420
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

-Individuals unable to provide informed consent

Primary outcomes:
measure: Home Literacy Environment Questionnaire
timeFrame: 2 months
measure: Home Literacy Environment Questionnaire
timeFrame: 10 months
measure: Parent Responsiveness Questionnaire
timeFrame: 2 months
measure: Parent Responsiveness Questionnaire
timeFrame: 10 months
measure: Family Health Routines Questionnaire
timeFrame: 2 months
measure: Family Health Routines Questionnaire
timeFrame: 10 months
measure: Caregiver Attitudes About Reading Questionnaire
timeFrame: 2 months
measure: Caregiver Attitudes About Reading Questionnaire
timeFrame: 10 months
measure: Child Vocabulary Assessment
timeFrame: 2 months
measure: Child Vocabulary Assessment
timeFrame: 10 months
measure: Child Language Skills Assessment
timeFrame: 10 months
measure: Child Literacy Skills Assessment
timeFrame: 2 months
measure: Child Literacy Skills Assessment
timeFrame: 10 months
measure: Child Social-emotional Development Questionnaire
timeFrame: 2 months
measure: Child Social-emotional Development Questionnaire
timeFrame: 10 months
Secondary outcomes:
measure: Child Media Use Questionnaire
timeFrame: 2 months
measure: Child Media Use Questionnaire
timeFrame: 10 months.
measure: Child Sleep Routines Questionnaire
timeFrame: 2 months
measure: Child Sleep Routines Questionnaire
timeFrame: 10 months
measure: Child Self-regulation Questionnaire
timeFrame: 2 months
measure: Child Self-regulation Questionnaire
timeFrame: 10 months
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Child Health Institute
state: New Jersey
Study officials:
affiliation: Rutgers University
name: Manuel E Jimenez, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: