Hypoxic Ischaemic Encephalopathy (HIE)NCT06643598
Healing Tiny Minds: Rural Recovery Through Virtual and Lived Experience Care
A study testing Abecedarian Approach in people with Hypoxic Ischaemic Encephalopathy (HIE) and Premature Birth, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Hypoxic Ischaemic Encephalopathy (HIE), Premature Birth, Cerebral Palsy
- What is being tested?
- Abecedarian Approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2025to Mar 2030
- 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 Up to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- IPNH-NDCP patients, including:
- Term-born children diagnosed during the neonatal period with hypoxic-ischemic encephalopathy, or
- premature children (born at less than 28 weeks gestational age).
- Parent or legal guardian will also be enrolled as a participant
- Parents must be English-speaking (able to provide consent and complete questionnaires).
Who cannot join
- Not suitable for study participation due to other reasons at the discretion of the investigator.
- Infants with chromosomal abnormalities, genetic syndromes (for example, such as Down Syndrome or Trisomy18) and major congenital malformations will be excluded.
- Infants with vision impairment will also be excluded from the study, as our study procedures do require intact vision to be able to complete.
- For parents or legal guardians, there are no exclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin Madison
Madison, Wisconsin, 53715
Melisa Carrasco McCaul, MD, PhD, 608-577-2415
About this study
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.
- Conditions
- Hypoxic Ischaemic Encephalopathy (HIE), Premature Birth, Cerebral Palsy, Neurological Disorder
- Being tested
- Abecedarian Approach
- Medical subject headings
- Hypoxia-Ischemia, Brain, Premature Birth, Cerebral Palsy, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abecedarian ApproachBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Abecedarian Approach |
| Feasibility Group | Experimental | Participants will be in fewer sessions in order to assess whether the intervention is accepted by the parents. Receives: Behavioral: Abecedarian Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Assessed biweekly from enrollment to end of treatment (up to 260 weeks)
Secondary outcomes (6)
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.
Measured: Data collected at 12, 24, 36, 48, and 60 month time points
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start3 Jun 2025
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic Ischaemic Encephalopathy (HIE)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melisa Carrasco McCaul, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643598
- Sponsor's protocol ID
- 2024-1658
- Other IDs
- Protocol Version 3/11/2026, A535100
- Status last verified
- Mar 2026
- First submitted
- 10 Oct 2024
- Last updated
- 27 Mar 2026
- 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 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Tiny Minds: Rural Recovery Through Virtual and Lived Experience Care
- ClinicalTrials.gov ID
- NCT06643598
- Acronym / sponsor ID
- 2024-1658
- Conditions
- Hypoxic Ischaemic Encephalopathy (HIE), Premature Birth, Cerebral Palsy, Neurological Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 16 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Abecedarian ApproachIn the Virtual Abecedarian Approach Intervention, children will partake in the Abecedarian Approach Intervention through a virtual format. |
| Feasibility Group | Experimental | Behavioral: Abecedarian ApproachParticipants will be in fewer sessions in order to assess whether the intervention is accepted by the parents. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- Not suitable for study participation due to other reasons at the discretion of the investigator.
- Infants with chromosomal abnormalities, genetic syndromes (for example, such as Down Syndrome or Trisomy18) and major congenital malformations will be excluded.
- Infants with vision impairment will also be excluded from the study, as our study procedures do require intact vision to be able to complete.
- For parents or legal guardians, there are no exclusion criteria.
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 |
|---|---|---|
| Abecedarian ApproachThe 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. | Behavioural | Feasibility Group, Virtual Abecedarian Approach Intervention |
Primary outcome
Parent Satisfaction Questionnaire
Time frame: Assessed at end of treatment (up to 60 months)
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.
Number of Sessions Attended
Time frame: Assessed biweekly from enrollment to end of treatment (up to 260 weeks)
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).
6 secondary outcomes
Bayley Assessment
Time frame: Data collected at 12, 24, 36, 48, and 60 month time points
Behavior Reporting Inventory of Executive Function - Preschool Version (BRIEF-P)
Time frame: Data collected at the 24, 36, 48, and 60 month time points
Pediatric Quality of Life Inventory (PedsQL)
Time frame: Data collected at baseline, 24, 36, 48 and 60 month time points
Early Executive Functions Questionnaire (EEFQ)
Time frame: Data collected at baseline, 12, and 24 month time points
NIH Baby/Infant and NIH Pediatric Toolbox
Time frame: Data collected at 12, 24, 36, 48, and 60-month time points
Infant Attention Task (IAT) measured in seconds
Time frame: baseline and 12 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 27 Mar 2026.
Related trials for Hypoxic Ischaemic Encephalopathy (HIE)
Not yet recruiting
Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
RecruitingPhase 2
The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
Recruiting
Neuro-MoD: Neuroplasticity With Motor Development
Perinatal Brain Injury
RecruitingPhase 2
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
Neonatal Seizure, Neonatal Encephalopathy
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.
Melisa Carrasco McCaul, MD, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abecedarian Approach in people with Hypoxic Ischaemic Encephalopathy (HIE) and Premature Birth, run by University of Wisconsin, Madison 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 27 Mar 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 Melisa Carrasco McCaul, MD, PhD (608-577-2415, carrascomccaul@neurology.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent Satisfaction Questionnaire (time frame: Assessed at end of treatment (up to 60 months)). 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 27 Mar 2026.