Recruiting NCT06643598
Healing Tiny Minds: Rural Recovery Through Virtual and Lived Experience Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Abecedarian Approach.
- Who it may be relevant to
- Registry conditions: Hypoxic Ischaemic Encephalopathy (HIE), Premature Birth, Cerebral Palsy, Neurological Disorder. Basic parameters: up to 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral Abecedarian Approach
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.
Primary outcome measures
- Parent Satisfaction Questionnaire [Time frame: Assessed at end of treatment (up to 60 months)]
- Number of Sessions Attended [Time frame: Assessed biweekly from enrollment to end of treatment (up to 260 weeks)]
Secondary outcome measures (6)
- 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]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Wisconsin Madison — Madison
Identifiers
NCT: NCT06643598 · 2024-1658 · Protocol Version 3/11/2026 · A535100