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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 3/11/2026 | Other Identifier | UW Madison | |
| A535100 | Other Identifier | UW Madison |
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The goal of this behavioral-interventional study is to learn if the Abecedarian Approach implemented virtually for children ages 0-5 with a history of Hypoxic Ischaemic Encephalopathy (HIE) and/or premature birth produces the same effects as when administered at in-person facilities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Provided | No Intervention | In the No Intervention condition, at-risk children will receive the current standard of care, and no intervention. | |
| Virtual Abecedarian Approach Intervention | Experimental | In the Virtual Abecedarian Approach Intervention, children will partake in the Abecedarian Approach Intervention through a virtual format. |
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| Feasibility Group | Experimental | Participants will be in fewer sessions in order to assess whether the intervention is accepted by the parents. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abecedarian Approach | Behavioral | The Abecedarian Approach is an early childhood behavioral education program that aims to improve the learning and cognitive development of children in high-risk or at-risk communities. This study will test the efficacy of implementing this approach in a virtual format. |
| Measure | Description | Time Frame |
|---|---|---|
| Parent Satisfaction Questionnaire | Questionnaire measuring parent satisfaction with the intervention and effects given at the end of the virtual program. Responses as measured by answering either strongly agree, agree, disagree or strongly disagree. Responses will be measured at the end of the intervention at 60 months and reported as participant counts. | Assessed at end of treatment (up to 60 months) |
| Number of Sessions Attended | We will be taking attendance of sessions to measure parent compliance with the virtual program. Attendance will be taken for each live session (every other week) for the entire period of enrollment (260 weeks). | Assessed biweekly from enrollment to end of treatment (up to 260 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Bayley Assessment | The Bayley is a cognitive and motor assessment conducted by an interventionalist to assess a child's development in these domains. The highest possible score on a subtest or subdomain is 19, and the lowest score is 1. Scores from 8-12 are considered average. | Data collected at 12, 24, 36, 48, and 60 month time points |
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Inclusion Criteria:
IPNH-NDCP patients, including:
Parent or legal guardian will also be enrolled as a participant
Parents must be English-speaking (able to provide consent and complete questionnaires).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melisa Carrasco McCaul, MD, PhD | Contact | 608-577-2415 | carrascomccaul@neurology.wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Melisa Carrasco McCaul, MD, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Madison | Recruiting | Madison | Wisconsin | 53715 | United States |
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| ID | Term |
|---|---|
| D020925 | Hypoxia-Ischemia, Brain |
| D047928 | Premature Birth |
| D002547 | Cerebral Palsy |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Behavior Reporting Inventory of Executive Function - Preschool Version (BRIEF-P) |
Behavior is reported in the BRIEF-P. Behaviors reported by parents can be used to predict later executive function exhibited by children. List of statements provided about child's behavior, parent will answer whether this is never a problem (N), sometimes a problem (S), and often a problem (O). Responses reported as participant counts, answering N more often is considered a better score. |
| Data collected at the 24, 36, 48, and 60 month time points |
| Pediatric Quality of Life Inventory (PedsQL) | The PedsQL is an inventory of statements scored by reverse-scoring responses to a 5-point Likert scale and then transforming them to a 0-100 scale. A higher score indicates a better quality of life. | Data collected at baseline, 24, 36, 48 and 60 month time points |
| Early Executive Functions Questionnaire (EEFQ) | A questionnaire is given to parents that assesses what executive functions children are exhibiting. More functions exhibited means further along in executive function development. EEFQ consists of 31 tasks parent is scoring child on, there are 7 options they can choose from regarding how that child performs the task, and in turn are scored 1-7 on the task. Tasks listed as designed to measure cognitive executive function, which should be increasing with age, higher scores are indicative of higher cognitive executive function. | Data collected at baseline, 12, and 24 month time points |
| NIH Baby/Infant and NIH Pediatric Toolbox | A set of tests designed by the NIH administered electronically to children to assess attention, executive function, learning, memory, language, and numeracy/math. A higher early childhood composite score indicates better performance and more of the concept being measured. Early childhood composite score - 100 is the standard, ranges from 70 (extremely low functioning) -130 (extremely high functioning). | Data collected at 12, 24, 36, 48, and 60-month time points |
| Infant Attention Task (IAT) measured in seconds | A behavioral measure used with infants to assess attentional control and processing. Infants are presented with visual puppet stimuli four distinct "looks", and researchers record looking time, shifts in attention, or habituation patterns. More sustained attention in the early looks followed by habituation to the stimuli in the later looks often indicates better early attentional capacity. Total accumulated looking time to a stimulus in visual preference-type tasks commonly ranges from roughly 15-30+ seconds per trial, depending on the infant's age and the stimulus. | baseline and 12 months |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001925 | Brain Damage, Chronic |