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Completed

NCT Number: NCT05339464

Ready and Healthy for Kindergarten

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.

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Key information

Conditions

Parenting Behavior Communication Health Behavior Language Development Literacy

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Child Health Institute

New Brunswick, New Jersey, 08901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Family Wellness program

Other

Weekly one-hour online workshops over an 8 week period. Families will also receive text message reminders as part of the intervention.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Home learning environment

    Time frame: Enrollment, 2months, 4months

    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

  2. Child vocabulary

    Time frame: Enrollment, 2months, 4months

    Child vocabulary will be assessed using an investigator developed measure. Higher scores indicate higher skills

  3. Child literacy skills

    Time frame: Enrollment, 2 months, 4 months

    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

  4. Home health routines

    Time frame: Enrollment, 2 months, 4 months

    Descriptive survey examining health routines including nutrition, physical activity, and sleep

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

Ready and Healthy for Kindergarten- Pilot Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 21, 2022
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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