Ready and Healthy for Kindergarten

Study Overview
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Brief Summary
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This study pilot tests a family wellness program that promotes academic and physical readiness for school among Latino dual language learners using a mixed methods and community engaged approach.

Detailed Description
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The investigators propose a pilot randomized controlled trial with wait list control to pilot test a family wellness program designed for Latino dual language learners entering Kindergarten and their families. The investigators will recruit up to 48 parent-child dyads to participate in the study. Families will be randomly assigned to session one beginning in June 2022 or session two beginning in July 2022. The investigators will examine the feasibility and acceptability of the family wellness program as well as preliminary effects on parenting behaviors and child language and literacy skills.

Official Title
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Ready and Healthy for Kindergarten- Pilot Study

Conditions
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Parenting, Language Development, Literacy, Health Behavior

Intervention / Treatment
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* Other: Family Wellness program


Participation Criteria
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Eligibility Criteria
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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 texts, and Willing to accept randomization Exclusion Criteria: Children with multiple congenital anomalies or genetic disorders and previously identified developmental delays will be excluded.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family wellness program- Group 1<br>This group will begin the family wellness program first; approximately, 5 weeks before group 2. The family wellness program consists of 8 parent-child workshops and text message reminders. | Other: Family Wellness program<br>* Weekly one-hour online workshops over an 8 week period. Families will also receive text message reminders as part of the intervention.<br>|
| Experimental: Family wellness program- Group 2<br>This group will begin the family wellness program approximately 5 weeks after group 1.The family wellness program consists of 8 parent-child workshops and text message reminders. | Other: Family Wellness program<br>* Weekly one-hour online workshops over an 8 week period. Families will also receive text message reminders as part of the intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of sessions attended | Number of sessions attended by participants will be used to assess the feasibility of the online family wellness program. | 2months | 
| Acceptability assessed by the Acceptability of Intervention Measure (AIM) | Data on perceived acceptability will be captured via parent report on the AIM survey. The AIM is a 4 item survey that assesses acceptability. Higher scores indicate higher acceptability. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Home learning environment | The home learning environment will be assessed with the StimQ, a caregiver-reported measure of cognitive stimulation for children that includes domains on the home literacy environment (READ scale) and responsiveness (Parental Verbal Responsiveness 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. 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 | Enrollment, 2months, 4months | 
| Child vocabulary | Child vocabulary will be assessed using an investigator developed measure. Higher scores indicate higher skills | Enrollment, 2months, 4months | 
| Child literacy skills | 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 | Enrollment, 2 months, 4 months | 
| Home health routines | Descriptive survey examining health routines including nutrition, physical activity, and sleep | Enrollment, 2 months, 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early literacy, Language development, Family literacy, Bilingualism, Community engagement