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Clinical Trials/NCT05339464
NCT05339464
Completed
N/A

Ready and Healthy for Kindergarten- Pilot Study

Rutgers, The State University of New Jersey1 site in 1 country32 target enrollmentMay 9, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parenting
Sponsor
Rutgers, The State University of New Jersey
Enrollment
32
Locations
1
Primary Endpoint
Acceptability assessed by the Acceptability of Intervention Measure (AIM)
Status
Completed
Last Updated
last year

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
May 9, 2022
End Date
September 25, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Manuel E. Jimenez, MD, MS

Assistant Professor of Pediatrics & Family Medicine and Community Health

Rutgers, The State University of New Jersey

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 texts, and
  • Willing to accept randomization

Exclusion Criteria

  • Children with multiple congenital anomalies or genetic disorders and previously identified developmental delays will be excluded.

Outcomes

Primary Outcomes

Acceptability assessed by the Acceptability of Intervention Measure (AIM)

Time Frame: 2 months

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.

Number of sessions attended

Time Frame: 2months

Number of sessions attended by participants will be used to assess the feasibility of the online family wellness program.

Secondary Outcomes

  • Child literacy skills(Enrollment, 2 months, 4 months)
  • Home health routines(Enrollment, 2 months, 4 months)
  • Home learning environment(Enrollment, 2months, 4months)
  • Child vocabulary(Enrollment, 2months, 4months)

Study Sites (1)

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