School ReadinessNCT06390215
Clinic-Based School Readiness Coaching
A study testing School Readiness Coaching Intervention in people with School Readiness, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The goal of this clinical trial is to examine how a clinic-based school readiness coaching session conducted by a community health worker for parents of 3-5-year-olds affects children's School Readiness (SR) skills and parents early SR knowledge and behaviors. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- School Readiness
- What is being tested?
- School Readiness Coaching Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 30 Jun 2026
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Receives primary care at one of 2 clinic sites
- Parent or caregiver of 3-6-year-old
- Child is eligible for Medicaid services
- Parent and child can communicate in English or Spanish
Who cannot join
- Child is too ill to participate
- Parents who are unable to complete study activities
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Jaime Peterson, MD, MPH, 575-770-8500, peterjai@ohsu.edu
Maya Postigo, BA, 360-271-3846, postigo@ohsu.edu
About this study
Official title: The School Readiness Journey: Capturing the Unheard Voices of Latino Parents
The goal of this clinical trial is to examine how a clinic-based school readiness coaching session conducted by a community health worker for parents of 3-5-year-olds affects children's School Readiness (SR) skills and parents early SR knowledge and behaviors. The main questions it aims to answer are: What impact does the clinic-based coaching session have on preschool-aged children's school readiness skills and their parents' confidence in supporting and practicing early math and literacy behaviors at home? Participants will receive a 1-hr coaching session at their pediatric clinic and return after three months for a follow-up session. Researchers will compare pre-and-post child and parent SR outcomes between these two sessions.
Read the detailed description
The goal of this clinical trial is to examine how a clinic-based school readiness coaching session conducted by a community health worker for parents of 3-5-year-olds affects children's school readiness (SR) skills and parents early SR knowledge and behaviors. The main questions it aims to answer are: What impact does the clinic-based coaching session have on preschool-aged children's school readiness skills as measured by the Brigance Early Childhood Screen III? and What impact does the clinic-based coaching session have on parents' confidence in supporting and practicing early math and literacy behaviors at home using the DREME Parent Beliefs Survey? The secondary question this study aims to evaluate is: Does the 1-hr school readiness coaching session affect rates of well-child checks at the pediatric clinic? Participants will receive a 1-hr coaching session at their pediatric clinic and return after three months for a follow-up session. Researchers will compare pre-and-post Brigance scores for the child and pre-and post parent SR confidence DREME scores.
- Conditions
- School Readiness
- Being tested
- School Readiness Coaching Intervention
- Keywords
- School Readiness, Kindergarten, Early Learning, Coaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School Readiness Coaching InterventionBehavioural
Two 1-hr School Readiness Coaching Session
| Study group | Role | What they receive |
|---|---|---|
| School Readiness Coaching Intervention | Experimental | Two 1-hr individualized parent-child School Readiness Coaching Sessions conducted with Community Health Worker to assess child and parent school readiness skills and behaviors and provide parents with modeling, tools, and resources to support parent early math and literacy skills for home practice and connect them to preschool and community resources. Receives: Behavioral: School Readiness Coaching Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in child's school readiness skills measured by the Brigance Early Childhood Screen III for 3-5-year-olds.
The Early Childhood Screens III, available in three age-specific volumes, evaluate the key predictors of school success across the domains of Physical Development, Language Development, Academic Skills/Cognitive Development, and Self-help and Social-Emotional Skills. Composite score range is 0-100 with higher score indicating a better outcome.
Measured: Baseline and month 3
Change in parent confidence teaching math and literacy measured by the DREME Parent Beliefs Survey
The DREME Parent Beliefs Survey is composed of 6 items that assess parent confidence and beliefs regarding teaching and practicing math and literacy with their child.
Measured: Baseline and month 3
Secondary outcomes (1)
Change in rates of well-child checks at the pediatric clinic.
Clinic will generate well-child checks reports for children enrolled to compare to clinic average.
Measured: Year one and year two
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 May 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for School ReadinessStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Peterson, Oregon Health and Science University
- Investigators
- Jaime Peterson, MD, MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390215
- Sponsor's protocol ID
- STUDY00021040
- Other IDs
- PPQ#1023820
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The School Readiness Journey: Capturing the Unheard Voices of Latino Parents
- ClinicalTrials.gov ID
- NCT06390215
- Acronym / sponsor ID
- STUDY00021040
- Conditions
- School Readiness
- Keywords
- School Readiness, Kindergarten, Early Learning, Coaching
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 30 Apr 2024 (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.
The goal of this clinical trial is to examine how a clinic-based school readiness coaching session conducted by a community health worker for parents of 3-5-year-olds affects children's School Readiness (SR) skills and parents early SR knowledge and behaviors. The main questions it aims to answer are: What impact does the clinic-based coaching session have on preschool-aged children's school readiness skills and their parents' confidence in supporting and practicing early math and literacy behaviors at home? Participants will receive a 1-hr coaching session at their pediatric clinic and return after three months for a follow-up session. Researchers will compare pre-and-post child and parent SR outcomes between these two sessions.
Detailed description
The goal of this clinical trial is to examine how a clinic-based school readiness coaching session conducted by a community health worker for parents of 3-5-year-olds affects children's school readiness (SR) skills and parents early SR knowledge and behaviors. The main questions it aims to answer are: What impact does the clinic-based coaching session have on preschool-aged children's school readiness skills as measured by the Brigance Early Childhood Screen III? and What impact does the clinic-based coaching session have on parents' confidence in supporting and practicing early math and literacy behaviors at home using the DREME Parent Beliefs Survey? The secondary question this study aims to evaluate is: Does the 1-hr school readiness coaching session affect rates of well-child checks at the pediatric clinic? Participants will receive a 1-hr coaching session at their pediatric clinic and return after three months for a follow-up session. Researchers will compare pre-and-post Brigance scores for the child and pre-and post parent SR confidence DREME scores.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| School Readiness Coaching Intervention | Experimental | Behavioral: School Readiness Coaching InterventionTwo 1-hr individualized parent-child School Readiness Coaching Sessions conducted with Community Health Worker to assess child and parent school readiness skills and behaviors and provide parents with modeling, tools, and resources to support parent early math and literacy skills for home practice and connect them to preschool and community resources. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Receives primary care at one of 2 clinic sites
- Parent or caregiver of 3-6-year-old
- Child is eligible for Medicaid services
- Parent and child can communicate in English or Spanish
Key exclusion criteria (2 listed)
- Child is too ill to participate
- Parents who are unable to complete study activities
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 |
|---|---|---|
| School Readiness Coaching InterventionTwo 1-hr School Readiness Coaching Session | Behavioural | School Readiness Coaching Intervention |
Primary outcome
Change in child's school readiness skills measured by the Brigance Early Childhood Screen III for 3-5-year-olds.
Time frame: Baseline and month 3
The Early Childhood Screens III, available in three age-specific volumes, evaluate the key predictors of school success across the domains of Physical Development, Language Development, Academic Skills/Cognitive Development, and Self-help and Social-Emotional Skills. Composite score range is 0-100 with higher score indicating a better outcome.
Change in parent confidence teaching math and literacy measured by the DREME Parent Beliefs Survey
Time frame: Baseline and month 3
The DREME Parent Beliefs Survey is composed of 6 items that assess parent confidence and beliefs regarding teaching and practicing math and literacy with their child.
1 secondary outcome
Change in rates of well-child checks at the pediatric clinic.
Time frame: Year one and year two
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Individual participant dataSharing planned: No
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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.
Jaime Peterson, MD, MPH principal investigator
Oregon Health and Science 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 School Readiness Coaching Intervention in people with School Readiness, run by Oregon Health and Science University 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaime Peterson, MD, MPH (575-770-8500, peterjai@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in child's school readiness skills measured by the Brigance Early Childhood Screen III for 3-5-year-olds. (time frame: Baseline and month 3). 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 2 May 2024.