Term InfantBUILDNCT06638801
Brain Uptrain to Improve Learning and Development
A study testing Coach-led caregiver-implemented early literacy and developmental programming and Reach Out and Read Training in people with Term Infant and Late Preterm Infant, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to see if an early literacy and developmental program in addition to shared reading can increase developmental test scores at 24 months of age. All caregivers of infants in this study will receive shared reading training. Read more about this study
- Who is it for?
- Ages 1 day to 7 days
- Conditions the study is for
- Term Infant, Late Preterm Infant
- What is being tested?
- Coach-led caregiver-implemented early literacy and developmental programming and Reach Out and Read Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2025to 18 Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 day to 7 days
- All sexes
- No healthy volunteers
- Child
Inclusion Criteria: inborn at UAB, delivered at more than 35 weeks' gestation, planned for discharge home after initial hospitalization.
-
Exclusion Criteria: a major malformation, a known syndrome, admitted to the NICU, in DHR custody, enrolled in a competing study, and family's primary language is other than English or Spanish.
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tamaryn Garcia contact
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Colm P Travers, MD, 2059344680, cptravers@uabmc.edu
Jillian Hamilton, PhD, 2059344680, jchamilton@uabmc.edu
About this study
Official title: Brain Uptrain to Improve Learning and Development: A Randomized Clinical Trial
The purpose of this study is to see if an early literacy and developmental program in addition to shared reading can increase developmental test scores at 24 months of age. All caregivers of infants in this study will receive shared reading training. Half of the caregivers will be trained in an additional coach-led caregiver-implemented early literacy and numeracy program. Information related to infant development will be collected from parent surveys, medical records, and questionnaires and assessments.
Read the detailed description
This study will test the hypothesis that in term or late preterm infants who are discharged home from the newborn nursery, a coach-led caregiver-implemented early literacy and developmental program in addition to shared reading, compared with shared reading alone, will increase the Ages and Stages Questionnaire® score at 24 months. This will be a double blind randomized controlled trial with 1:1 parallel allocation using stratified permuted block design. Randomization will be stratified by gestational age (≥ 35 to <38 weeks and ≥ 38 weeks). Randomization of twins and higher orders (when eligible) will be to the same group. Term and late preterm infants ≥ 35 weeks' gestation admitted to the newborn nursery are eligible for inclusion if they are being discharged home. We will exclude infants admitted to the NICU, infants with a known syndrome or major malformation, infants in DHR custody, infants enrolled in a competing study, and infants of families with a primary language other than English or Spanish. All study participants will receive shared reading information at scheduled well-child checks. Caregivers of infants in the intervention group will receive additional coach-led caregiver-implemented early literacy and developmental program. We will complete an ASQ-3 online or by telephone at 12 months, 24 months, and 36 months. We will also measure early literacy at 3 years, 4 years, and 5 years. The primary outcome will be the ASQ-3 scores at 24 months.
- Conditions
- Term Infant, Late Preterm Infant
- Being tested
- Coach-led caregiver-implemented early literacy and developmental programming, Reach Out and Read Training
- Keywords
- maternal training, cognitive scores, reading, literacy, numeracy
- Medical subject headings
- Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coach-led caregiver-implemented early literacy and developmental programmingBehavioural
Caregivers will receive training about child brain development in the first 3 years of life. The training will emphasize the areas of spoken words, physical education, pointer-finger concept, focus and label, reading lessons, and mathematics.
Reach Out and Read TrainingBehavioural
Reach Out and Read parent training
| Study group | Role | What they receive |
|---|---|---|
| Reach Out and Read plus intervention | Experimental | Reach Out and Read Training in addition to coach-led caregiver-implemented early literacy and developmental program Receives: Behavioral: Coach-led caregiver-implemented early literacy and developmental programming; Behavioral: Reach Out and Read Training |
| Reach out and Read only | Active comparator | Reach Out and Read at well child visits Receives: Behavioral: Reach Out and Read Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASQ-3 scores
The total Ages and Stages Questionnaires 3rd Edition score at 24 months
Measured: 24 month well-child visit
Secondary outcomes (12)
ASQ-3 scores
The total Ages and Stages Questionnaires 3rd Edition score at 12 months
Measured: 12 month well-child visit
ASQ-3 scores
The total Ages and Stages Questionnaires 3rd Edition score at 36 months
Measured: 36 month well-child visit
ASQ scores below -2SD
The proportion of children with Ages and Stages Questionnaires 3rd Edition 2 standard deviations of more below the mean at 12 months
Measured: 12 month well-child visit
ASQ scores below -2SD
The proportion of children with Ages and Stages Questionnaires 3rd Edition 2 standard deviations of more below the mean at 24 months
Measured: 24 month well-child visit
ASQ scores below -2SD
The proportion of children with Ages and Stages Questionnaires 3rd Edition 2 standard deviations of more below the mean at 36 months
Measured: 36 month well-child visit
ASQ scores below -1SD
The proportion of children with Ages and Stages Questionnaires 3rd Edition one standard deviation of more below the mean at 12 months
Measured: 12 month well-child visit
ASQ scores below -1SD
The proportion of children with Ages and Stages Questionnaires 3rd Edition one standard deviation of more below the mean at 24 months
Measured: 24 month well-child visit
ASQ scores below -1SD
The proportion of children with Ages and Stages Questionnaires 3rd Edition one standard deviation of more below the mean at 36 months
Measured: 36 month well-child visit
Literacy Scores
Get Ready To Read- Revised, McArthur-Bates Communicative Development Inventory, Preschool Language Scales- Fifth Edition scores at 36 months
Measured: 36 months
Literacy Scores
Get Ready To Read- Revised, McArthur-Bates Communicative Development Inventory, Preschool Language Scales- Fifth Edition
Measured: 48 months
Literacy Scores
Get Ready To Read- Revised, McArthur-Bates Communicative Development Inventory, Preschool Language Scales- Fifth Edition scores at 60 months
Measured: 60 months
Kindergarten Readiness
Bracken School Readiness Assessment-Third Edition scores at 60 months
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start18 Feb 2025
- Primary completion18 Feb 2029 (estimated)
- Study completion18 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Term InfantStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colm Travers, University of Alabama at Birmingham
- Investigators
- Colm P Travers, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638801
- Sponsor's protocol ID
- IRB-300013307
- Other IDs
- UAB
- Acronym
- BUILD
- Status last verified
- Jul 2026
- First submitted
- 10 Oct 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Uptrain to Improve Learning and Development: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06638801
- Acronym / sponsor ID
- BUILD / IRB-300013307
- Conditions
- Term Infant, Late Preterm Infant
- Keywords
- maternal training, cognitive scores, reading, literacy, numeracy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 18 Feb 2029 (estimated)
- Study completion
- 18 Jun 2031 (estimated)
- First posted
- 15 Oct 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 purpose of this study is to see if an early literacy and developmental program in addition to shared reading can increase developmental test scores at 24 months of age. All caregivers of infants in this study will receive shared reading training. Half of the caregivers will be trained in an additional coach-led caregiver-implemented early literacy and numeracy program. Information related to infant development will be collected from parent surveys, medical records, and questionnaires and assessments.
Detailed description
This study will test the hypothesis that in term or late preterm infants who are discharged home from the newborn nursery, a coach-led caregiver-implemented early literacy and developmental program in addition to shared reading, compared with shared reading alone, will increase the Ages and Stages Questionnaire® score at 24 months. This will be a double blind randomized controlled trial with 1:1 parallel allocation using stratified permuted block design. Randomization will be stratified by gestational age (≥ 35 to <38 weeks and ≥ 38 weeks). Randomization of twins and higher orders (when eligible) will be to the same group. Term and late preterm infants ≥ 35 weeks' gestation admitted to the newborn nursery are eligible for inclusion if they are being discharged home. We will exclude infants admitted to the NICU, infants with a known syndrome or major malformation, infants in DHR custody, infants enrolled in a competing study, and infants of families with a primary language other than English or Spanish. All study participants will receive shared reading information at scheduled well-child checks. Caregivers of infants in the intervention group will receive additional coach-led caregiver-implemented early literacy and developmental program. We will complete an ASQ-3 online or by telephone at 12 months, 24 months, and 36 months. We will also measure early literacy at 3 years, 4 years, and 5 years. The primary outcome will be the ASQ-3 scores at 24 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reach Out and Read plus intervention | Experimental | Behavioral: Coach-led caregiver-implemented early literacy and developmental programming, Behavioral: Reach Out and Read TrainingReach Out and Read Training in addition to coach-led caregiver-implemented early literacy and developmental program |
| Reach out and Read only | Active comparator | Behavioral: Reach Out and Read TrainingReach Out and Read at well child visits |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Coach-led caregiver-implemented early literacy and developmental programmingCaregivers will receive training about child brain development in the first 3 years of life. The training will emphasize the areas of spoken words, physical education, pointer-finger concept, focus and label, reading lessons, and mathematics. | Behavioural | Reach Out and Read plus intervention |
| Reach Out and Read TrainingReach Out and Read parent training | Behavioural | Reach Out and Read plus intervention, Reach out and Read only |
Primary outcome
ASQ-3 scores
Time frame: 24 month well-child visit
The total Ages and Stages Questionnaires 3rd Edition score at 24 months
12 secondary outcomes
ASQ-3 scores
Time frame: 12 month well-child visit
ASQ-3 scores
Time frame: 36 month well-child visit
ASQ scores below -2SD
Time frame: 12 month well-child visit
ASQ scores below -2SD
Time frame: 24 month well-child visit
ASQ scores below -2SD
Time frame: 36 month well-child visit
ASQ scores below -1SD
Time frame: 12 month well-child visit
ASQ scores below -1SD
Time frame: 24 month well-child visit
ASQ scores below -1SD
Time frame: 36 month well-child visit
Literacy Scores
Time frame: 36 months
Literacy Scores
Time frame: 48 months
Literacy Scores
Time frame: 60 months
Kindergarten Readiness
Time frame: 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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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.
Tamaryn Garcia contact
Colm P Travers principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coach-led caregiver-implemented early literacy and developmental programming and Reach Out and Read Training in people with Term Infant and Late Preterm Infant, run by University of Alabama at Birmingham 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?
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: looking for participants now, as of the sponsor's last update on 16 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Colm Travers ((205) 934-4680, cptravers@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASQ-3 scores (time frame: 24 month well-child visit). 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 16 Jul 2026.