Ready and Healthy for Kindergarten

Health Behavior Clinical Trial

Official title:

Ready and Healthy for Kindergarten- Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05339464
• Other study ID #: Pro2021001575
• Secondary ID: R18HS028574
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 9, 2022
• Est. completion date: June 2024

Study information

• Verified date: October 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: June 2024
• Est. primary completion date: September 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Health Behavior
• Language Development
• Literacy
• Parenting

Intervention

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.

Locations

Country	Name	City	State
United States	Child Health Institute	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of sessions attended	Number of sessions attended by participants will be used to assess the feasibility of the online family wellness program.	2months
Primary	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	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
Secondary	Child vocabulary	Child vocabulary will be assessed using an investigator developed measure. Higher scores indicate higher skills	Enrollment, 2months, 4months
Secondary	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
Secondary	Home health routines	Descriptive survey examining health routines including nutrition, physical activity, and sleep	Enrollment, 2 months, 4 months