Ready and Healthy for Kindergarten

NCT05339464 | Completed

• 2 other identifiers: Pro2021001575R18HS028574
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Parenting; Language Development; Literacy; Health Behavior

Keywords

Early literacy; Language development; Family literacy; Bilingualism; Community engagement

Outcome Measures

Primary Outcomes (2)

• Number of sessions attended

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

  2months

• 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 Outcomes (4)

• Home learning environment

  Enrollment, 2months, 4months

• Child vocabulary

  Enrollment, 2months, 4months

• Child literacy skills

  Enrollment, 2 months, 4 months

• Home health routines

  Enrollment, 2 months, 4 months

Study Arms (2)

Family wellness program- Group 1

EXPERIMENTAL

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

Family wellness program- Group 2

EXPERIMENTAL

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

Interventions

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.

Family wellness program- Group 1; Family wellness program- Group 2

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Child Health Institute

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Literacy; Health Behavior

Condition Hierarchy (Ancestors)

Communication; Behavior

Study Officials

• Manuel Jimenez, MD, MS

  Rutgers University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics & Family Medicine and Community Health

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 21, 2022
• Study Start: May 9, 2022
• Primary Completion: September 25, 2022
• Study Completion: September 25, 2022
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will become available after the study is completed and primary study findings are published in peer-reviewed journals for 10 years after study completion.
• Access Criteria: Researchers from accredited institutions may request access to the data for non-profit research. Permission and access will be granted on an ad hoc basis. Only deidentified data will be made available.

Locations

US (1)