Sparking Potential, Revealing Infant Neurocognitive Traits
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-24
SponsorUniversity of Wisconsin, Madison
About this trial
This research focuses on the long-term cognitive development of children, including healthy infants and those who had a perinatal brain injury. As part of this research study, children complete virtual game and assessments. Parents will be asked to fill out questionnaires about their child's behavior and stress in the home. All study visits will take place online via Zoom.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Child-parent dyads will be recruited to the study.
Children 3-24 months with and without a history of a perinatal brain injury (PBI) will be included in this study.
Children diagnosed during the neonatal period with hypoxic-ischemic encephalopathy,
Children born at a premature gestational age (born at less than 32 weeks gestational age).
Disqualifiers
a prior history of brain injury
a diagnosis of cerebral palsy
a history of a neurological disorder
prior admission to the Neonatal Intensive Care Unit (NICU)
Trial population
Infants ages 6-24 months located across the United States and internationally.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 2 trial groupsGroup A: Children with perinatal brain injuries
Group B: Healthy Children
Trial outcomes
Primary outcomes
1
Infant Attention Task (IAT)
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.
Time frame
Assessed at the 12,18, and 24-month time points2
Cognitive Adaptive Test/Clinical Linguistic & Auditory Milestone Scale (CAPUTE)
An assessment for infants and young children that evaluates cognitive and language development. It combines two scales: CAT (Cognitive Adaptive Test) for problem-solving and adaptive skills, and CLAMS (Clinical Linguistic and Auditory Milestone Scale) for language and auditory milestones. Scores provide age-equivalent estimates of cognitive and language abilities. The CAPUTE scores are reported as developmental quotients ranging roughly from 40 to 160, with scores ≥85 considered within normal limits, 70-84 indicating borderline development, and \<70 suggesting developmental delay.
Time frame
Assessed at the 6 and 12-month time pointsSecondary outcomes
1
Confusion, Hubbub and Order Scale (CHAOS)
Parents and/or Caregivers rate items describing household noise, crowding, and routine; responses are summed to create a total CHAOS score. The CHAOS total score ranges from 15 to 60, with higher scores indicating a more chaotic, noisy, and disorganized home environment; scores below 25 typically reflect lower chaos, whereas scores above 35 suggest high household chaos.
Time frame
Assessed at the 6, 9,12, and 24-month time point2
Parental Stress Scale
A questionnaire which measures stress and satisfaction associated with parenting; items are summed to create a total parental stress score. On the Parental Stress Scale, total scores range from 18 to 90, with higher scores indicating greater levels of parental stress and lower scores reflecting lower stress and more satisfaction in the parenting role.
Time frame
Assessed at the 6,12,18, and 24-month time points3
Parenting Daily Hassle (PDH) Scales: Frequency Score
A parent-report measure assessing the frequency and intensity of everyday parenting stressors (e.g., child demands, disruptions to routines); item ratings are summed or averaged to yield frequency and intensity scores. On the PDH Scale, frequency scores range from 0 to 80 with higher totals indicating more frequent and/or more stressful everyday parenting hassles.
Time frame
Assessed at the 6,12,18, and 24-month time point4
Parenting Daily Hassle (PDH) Scales: Intensity Score
A parent-report measure assessing the frequency and intensity of everyday parenting stressors (e.g., child demands, disruptions to routines); item ratings are summed or averaged to yield frequency and intensity scores. On the PDH Scale, intensity scores range from 0 to 100 with higher totals indicating more frequent and/or more stressful everyday parenting hassles.
Time frame
Assessed at the 6,12,18, and 24-month time pointSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov