Early Math LearningMATHNCT05884541
Promoting Math in Young Children: Leveraging Pediatric Clinics to Reach Underrepresented Children in Rural Communities
A study testing TipsbyText Messages in people with Early Math Learning, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The goals of this clinical trial to examine how pediatricians prescribing early math enriching texts to the parents of their patients affects the early math skills of under-resourced pre-kindergarten-aged children in rural Oregon. Read more about this study
- Who is it for?
- Ages 36 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Early Math Learning
- What is being tested?
- TipsbyText Messages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 31 Aug 2025
- 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 36 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parents of participants must be at least 18 years of age
- Child must be 3 or 4 years old at the time of screening
- Child receives care at a participating Oregon Rural Practice-based Research Network (ORPRN) clinic
- Parent and child can communicate in English or Spanish
- Parent is able to give informed consent
- Child is eligible for Medicaid services
Who cannot join
- Parent is not able to receive text messages
- Parent is not able to read text messages
- Child is too ill to participate
- Parents who are unable to complete study activities
- Child has a sibling currently enrolled in the study
- Child has a developmental delay including neurodevelopmental disorders such as autism or syndromes associated with developmental delay (e.g. cerebral palsy, seizure disorders, attention deficit / hyperactivity disorder). Isolated expressive speech delay is not a developmental exclusion criteria.
Trial locations and contacts
1 site in 1 country.
LeAnn Michaels contact
United States1 site, 1 recruiting
- Recruiting
Oregon Rural Practice Research Network
Portland, Oregon, 97239
LeAnn Michaels, BS, michaell@ohsu.edu
Kendall Dunlop-Korsness, MPH, dunlopko@ohsu.edu
About this study
The goals of this clinical trial to examine how pediatricians prescribing early math enriching texts to the parents of their patients affects the early math skills of under-resourced pre-kindergarten-aged children in rural Oregon. The main question it aims to answer is: What is the impact of the text intervention on early math skills in preschool-aged children? Participants will be randomized to receive the early math text intervention or standard of care. Researchers will compare pre-and-post math performance between the intervention and control group.
Read the detailed description
The goals of this clinical trial to examine how pediatricians prescribing early math enriching texts (TipsbyText) to parents of 3-4 year olds affects the math skills of under-resourced pre-kindergarten-aged children in rural Oregon. The main question it aims to answer is: What is the impact of the text intervention on early math skills in preschool-aged children using the Research-based Early Math Assessment (REMA-Brief)? Two secondary questions of the study are: What is the impact on child literacy using the Phonological Awareness Literacy Screening Tool (PALS-PreK) and parent confidence using the Development and Research in Early Math Education (DREME)? Participants will be randomized to receive intervention (the early math text intervention) or control (no texts). Researchers will compare pre-and-post math performance on the REMA-Brief (primary outcome), PALS-PreK (secondary child outcome) and DREME (secondary parent outcome) between the intervention and control group.
- Conditions
- Early Math Learning
- Being tested
- TipsbyText Messages
- Keywords
- early math learning, preschool, rural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TipsbyText MessagesOther
Texts sent to caregivers meant to increase parent child interaction around math and literacy, sent to participants 4x a week for 8 months
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Children and parents receiving Early Math Texts (TipsbyText) Receives: Other: TipsbyText Messages |
| Control | No intervention | Children and parents not receiving Early Math Texts (TipsbyText) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in child early math skills measured by the Research-based Early Math Assessment (REMA-Brief)
The Research-based Early Math Assessment (REMA-Brief) REMA-Brief assesses core mathematical abilities of children in PK and Transitional Kindergarten (TK) using an individual interview format, with explicit protocol and scoring procedures. Abilities are assessed according to theoretically and empirically based developmental progressions that underlie mathematical learning trajectories. The REMA Brief is a content-referenced test, built on psychological development that includes normative interpretations. There are twenty items; with a maximum possible raw score is 28. Average T score is 50. Standard deviation is 7.
Measured: baseline and month 9
Secondary outcomes (2)
Change in child literacy measured by the Phonological Awareness Literacy Screening Tools (PALS-PreK) Score
Screening Tool (PALS-PreK) Score [ Time Frame: Baseline and month 9 ]
- The PALS-PreK measures preschoolers' knowledge of literacy fundamentals: name writing, alphabet knowledge, sound awareness, print and word awareness, rhyme awareness, and nursery rhyme awareness. The English and Spanish PALS-PreK versions slightly differ in content, investigators used the "name writing, alphabet knowledge, beginning sound awareness and nursery rhyme awareness" and each section will be scored separately. Name writing (max 7 points), alphabet knowledge (part A: 26 max; part B 26 max), beginning sound awareness (10 point max), print and word awareness (10 point max). Composite score range is 0-76 with higher score indicating a better outcome.
Measured: baseline and month 9
Change in parent confidence teaching math and literacy by the Development and Research in Early Math Education (DREME)
The DREME is a 17-item parent survey to assess parent confidence and beliefs regarding teaching and practicing math with their child.
Measured: baseline and month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 Aug 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Math LearningStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Sponsor
- Investigators
- Jaime W Peterson, MD, MPH, Principal investigator, Oregon Health and Science UniversityLisa Chamberlain, MD, MPH, Principal investigator, Stanford UniversitySusanna Loeb, PhD, Principal investigator, Stanford UniversityKendall Dunlop-Korsness, MPH, Study director, Oregon Health and Science UniversityLeAnn Michaels, BS, Study director, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884541
- Sponsor's protocol ID
- 1021594
- Acronym
- MATH
- Status last verified
- May 2023
- First submitted
- 23 May 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Math in Young Children: Leveraging Pediatric Clinics to Reach Underrepresented Children in Rural Communities
- ClinicalTrials.gov ID
- NCT05884541
- Acronym / sponsor ID
- MATH / 1021594
- Conditions
- Early Math Learning
- Keywords
- early math learning, preschool, rural
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 1 Jun 2023 (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 goals of this clinical trial to examine how pediatricians prescribing early math enriching texts to the parents of their patients affects the early math skills of under-resourced pre-kindergarten-aged children in rural Oregon. The main question it aims to answer is: What is the impact of the text intervention on early math skills in preschool-aged children? Participants will be randomized to receive the early math text intervention or standard of care. Researchers will compare pre-and-post math performance between the intervention and control group.
Detailed description
The goals of this clinical trial to examine how pediatricians prescribing early math enriching texts (TipsbyText) to parents of 3-4 year olds affects the math skills of under-resourced pre-kindergarten-aged children in rural Oregon. The main question it aims to answer is: What is the impact of the text intervention on early math skills in preschool-aged children using the Research-based Early Math Assessment (REMA-Brief)? Two secondary questions of the study are: What is the impact on child literacy using the Phonological Awareness Literacy Screening Tool (PALS-PreK) and parent confidence using the Development and Research in Early Math Education (DREME)? Participants will be randomized to receive intervention (the early math text intervention) or control (no texts). Researchers will compare pre-and-post math performance on the REMA-Brief (primary outcome), PALS-PreK (secondary child outcome) and DREME (secondary parent outcome) between the intervention and control group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: TipsbyText MessagesChildren and parents receiving Early Math Texts (TipsbyText) |
| Control | No intervention | –Children and parents not receiving Early Math Texts (TipsbyText) |
Who may qualify
- Ages
- 36 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Parents of participants must be at least 18 years of age
- Child must be 3 or 4 years old at the time of screening
- Child receives care at a participating Oregon Rural Practice-based Research Network (ORPRN) clinic
- Parent and child can communicate in English or Spanish
- Parent is able to give informed consent
Key exclusion criteria (6 listed)
- Parent is not able to receive text messages
- Parent is not able to read text messages
- Child is too ill to participate
- Parents who are unable to complete study activities
- Child has a sibling currently enrolled in the study
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 |
|---|---|---|
| TipsbyText MessagesTexts sent to caregivers meant to increase parent child interaction around math and literacy, sent to participants 4x a week for 8 months | Other | Intervention |
Primary outcome
Change in child early math skills measured by the Research-based Early Math Assessment (REMA-Brief)
Time frame: baseline and month 9
The Research-based Early Math Assessment (REMA-Brief) REMA-Brief assesses core mathematical abilities of children in PK and Transitional Kindergarten (TK) using an individual interview format, with explicit protocol and scoring procedures. Abilities are assessed according to theoretically and empirically based developmental progressions that underlie mathematical learning trajectories. The REMA Brief is a content-referenced test, built on psychological development that includes normative interpretations. There are twenty items; with a maximum possible raw score is 28. Average T score is 50. Standard deviation is 7.
2 secondary outcomes
Change in child literacy measured by the Phonological Awareness Literacy Screening Tools (PALS-PreK) Score
Time frame: baseline and month 9
Change in parent confidence teaching math and literacy by the Development and Research in Early Math Education (DREME)
Time frame: baseline and month 9
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
Related trials for Early Math Learning
Not yet recruiting
Intervention on Mathematical Problem-Solving Skills
Math Learning Disability, Learning Disabilities
Recruiting
Interventions in Mathematics and Cognitive Skills
Math Learning Disability, Child Development
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.
LeAnn Michaels contact
Jaime W Peterson, MD, MPH principal investigator
Oregon Health and Science University
Lisa Chamberlain, MD, MPH principal investigator
Stanford University
Susanna Loeb, PhD principal investigator
Stanford 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 TipsbyText Messages in people with Early Math Learning, 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 6 inclusion and 6 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 1 Nov 2023. 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 w Peterson, MD, MPH (5034941049, 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 early math skills measured by the Research-based Early Math Assessment (REMA-Brief) (time frame: baseline and month 9). 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 1 Nov 2023.