ParentingNCT05339464
Ready and Healthy for Kindergarten
A study testing Family Wellness program in people with Parenting and Language Development, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Parenting, Language Development, Literacy
- What is being tested?
- Family Wellness program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2022to 25 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Children with multiple congenital anomalies or genetic disorders and previously identified developmental delays will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Child Health Institute
New Brunswick, New Jersey, 08901
About this study
Official title: Ready and Healthy for Kindergarten- Pilot Study
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.
Read the 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.
- Conditions
- Parenting, Language Development, Literacy, Health Behavior
- Being tested
- Family Wellness program
- Keywords
- Early literacy, Language development, Family literacy, Bilingualism, Community engagement
- Medical subject headings
- Literacy, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Wellness programOther
Weekly one-hour online workshops over an 8 week period. Families will also receive text message reminders as part of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Family Wellness program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of sessions attended
Number of sessions attended by participants will be used to assess the feasibility of the online family wellness program.
Measured: 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.
Measured: 2 months
Secondary outcomes (4)
Home learning environment
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
Measured: Enrollment, 2months, 4months
Child vocabulary
Child vocabulary will be assessed using an investigator developed measure. Higher scores indicate higher skills
Measured: Enrollment, 2months, 4months
Child literacy skills
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
Measured: Enrollment, 2 months, 4 months
Home health routines
Descriptive survey examining health routines including nutrition, physical activity, and sleep
Measured: Enrollment, 2 months, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start9 May 2022
- Primary completion25 Sep 2022
- Study completion25 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Manuel E. Jimenez, MD, MS, Rutgers, The State University of New Jersey
- Investigators
- Manuel Jimenez, MD, MS, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339464
- Sponsor's protocol ID
- Pro2021001575
- Other IDs
- R18HS028574
- Status last verified
- Nov 2024
- First submitted
- 8 Apr 2022
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified quantitative data and associated documentation may be made available to users conducting non-profit research under a written data-sharing agreement
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ready and Healthy for Kindergarten- Pilot Study
- ClinicalTrials.gov ID
- NCT05339464
- Acronym / sponsor ID
- Pro2021001575
- Conditions
- Parenting, Language Development, Literacy, Health Behavior
- Keywords
- Early literacy, Language development, Family literacy, Bilingualism, Community engagement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 9 May 2022 (actual)
- Primary completion
- 25 Sep 2022 (actual)
- Study completion
- 25 Sep 2022 (actual)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family wellness program- Group 1 | Experimental | Other: Family Wellness programThis 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. |
| Family wellness program- Group 2 | Experimental | Other: Family Wellness programThis 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. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Children with multiple congenital anomalies or genetic disorders and previously identified developmental delays will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Wellness programWeekly one-hour online workshops over an 8 week period. Families will also receive text message reminders as part of the intervention. | Other | Family wellness program- Group 1, Family wellness program- Group 2 |
Primary outcome
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.
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.
4 secondary outcomes
Home learning environment
Time frame: Enrollment, 2months, 4months
Child vocabulary
Time frame: Enrollment, 2months, 4months
Child literacy skills
Time frame: Enrollment, 2 months, 4 months
Home health routines
Time frame: Enrollment, 2 months, 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: Yes. Deidentified quantitative data and associated documentation may be made available to users conducting non-profit research under a written data-sharing agreement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Jimenez, MD, MS principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Wellness program in people with Parenting and Language Development, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of sessions attended (time frame: 2months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.