Ready and Healthy for Kindergarten

Ready and Healthy for Kindergarten- Pilot Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Parenting; Health Behavior; Language Development; Literacy
• Intervention / Treatment: Other: Family Wellness program

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Child Health Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Family wellness program- Group 1; 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; Weekly one-hour online workshops over an 8 week period. Families will also receive text message reminders as part of the intervention.
Experimental: Family wellness program- Group 2; 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; Weekly one-hour online workshops over an 8 week period. Families will also receive text message reminders as part of the intervention.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Manuel Jimenez, MD, MS, Rutgers University

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Actual): September 27, 2022
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: April 8, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Community engagement; Bilingualism; Language development; Early literacy; Family literacy
• Other Study ID Numbers: Pro2021001575; R18HS028574 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified quantitative data and associated documentation may be made available to users conducting non-profit research under a written data-sharing agreement
• IPD Sharing Time Frame: Data will become available after the study is completed and primary study findings are published in peer-reviewed journals for 10 years after study completion.
• IPD Sharing Access Criteria: Researchers from accredited institutions may request access to the data for non-profit research. Permission and access will be granted on an ad hoc basis. Only deidentified data will be made available.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No