Ready and Healthy for Kindergarten

Sponsor
Rutgers, The State University of New Jersey (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05339464
Collaborator
Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)
48
1
2
12.7
3.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Family Wellness program
N/A

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
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Ready and Healthy for Kindergarten- Pilot Study
Actual Study Start Date :
May 9, 2022
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Number of sessions attended [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) [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 Outcome Measures

  1. Home learning environment [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 [Enrollment, 2months, 4months]

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

  3. Child literacy skills [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 [Enrollment, 2 months, 4 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 6 Years
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Child Health Institute New Brunswick New Jersey United States 08901

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Manuel Jimenez, MD, MS, Rutgers University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Manuel E. Jimenez, MD, MS, Assistant Professor of Pediatrics & Family Medicine and Community Health, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT05339464
Other Study ID Numbers:
  • Pro2021001575
  • R18HS028574
First Posted:
Apr 21, 2022
Last Update Posted:
Jun 1, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Manuel E. Jimenez, MD, MS, Assistant Professor of Pediatrics & Family Medicine and Community Health, Rutgers, The State University of New Jersey

Study Results

No Results Posted as of Jun 1, 2022