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Clinical Trials/NCT05339464
NCT05339464CompletedNot Applicable

Ready and Healthy for Kindergarten- Pilot Study

Rutgers, The State University of New Jersey2 sites in 1 country32 target enrollmentStarted: May 9, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
32
Locations
2
Primary Endpoint
Acceptability assessed by the Acceptability of Intervention Measure (AIM)

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
4 Years to 6 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Investigators

Sponsor Class
Other
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

Study Sites (2)

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