Brain Uptrain to Improve Learning and Development
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-7
SponsorUniversity of Alabama at Birmingham
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Coach-led caregiver-implemented early literacy and developmental programming
BehavioralCaregivers 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 Training
BehavioralReach Out and Read parent training
Treatment groups
188 Participants
are divided into 2 treatment groupsGroup A: Reach Out and Read plus interventionExperimental treatment 2 interventions
Group B: Reach out and Read onlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
ASQ-3 scores
The total Ages and Stages Questionnaires 3rd Edition score at 24 months
Time frame
24 month well-child visitSecondary outcomes
1
ASQ-3 scores
The total Ages and Stages Questionnaires 3rd Edition score at 12 months
Time frame
12 month well-child visit2
ASQ-3 scores
The total Ages and Stages Questionnaires 3rd Edition score at 36 months
Time frame
36 month well-child visit3
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
Time frame
12 month well-child visit4
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
Time frame
24 month well-child visitSponsors and contacts
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Source ClinicalTrials.gov