Infant, Low Birth Weight
Conditions
Interventions
for engagement during the intervention (Measure of Engagement-Observation)
regarding the caregiver/infant Interaction: (Parent-Child Early Relational Assessment)
This is a clinical, randomized and controlled study in parallel. Randomized by the website sealedenvelope.com, in a remote and in-person group and extracted by risk of developmental delay and risk of
regarding environmental changes (Affordances in the Home Environment for Motor Development) and regarding the Level of depression, anxiety and caregivers' stress (Depression, Anxiety and Stress Scale)
N02.421.143.130.320
F03.625
Sponsors
Universidade Federal de São Carlos - UFSCAR
Universidade Federal de São Carlos - UFSCAR
Eligibility
Age
3 Months to 9 Months
Inclusion criteria
Inclusion criteria: Infants aged between 3 and 9 months corrected age. Of both sexes. At biological risk - to be considered at risk, the infant must present at least one of the following factors: prematurity (<33 weeks of gestational age), low weight (below the 10th percentile according to gestational age and sex), asphyxia (Apgar score from 0 to 3 for more than 5 minutes, and/or neurological manifestations in the neonate such as seizures, coma or hypotonia, need for cardiorespiratory resuscitation or use of oxygen therapy, hospitalization in the Intensive Care Unit, General Movement Assessment (GMA) altered (absence of fidgety or abnormal fidgety), total score on the Hammersmith Neurological Examination (HINE), below 60 at three months, below 70 at six months and equal to or less than 73 at infants aged between nine and 12 monthsonths
Exclusion criteria
Exclusion criteria: Infants with genetic abnormalities; infants who are in a hospital environment; who are blind or deaf; with a clinical diagnosis of respiratory diseases; with congenital diseases such as heart disease, kidney or ophthalmological alterations; physiologically unstable infants; infants whose primary caregivers have cognitive or motor disabilities that prevent the understanding or performance of activities administered at home or are unable to take the infant to clinics the required number of days a week; and/or do not sign the Informed Consent Form
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| participation, assessed by the Young Children's Participation and Environment Measure (YC-PEM);engagement of the infant during the intervention, through the Measure of Engagement-Observation instrument (PRIME-O),;Mother interaction -child, assessment based on the Parent-Child Early Relational Assessment (PCERA) instrument;Environmental and contextual changes, assessed by the Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS);Level of depression and anxiety and caregivers' stress by the Depression, Anxiety and Stress Scale (DASS-21);;Perception of caregivers regarding the evolution and achievement of goals by the Canadian Occupational Performance Measure (COPM). ;Perception of the caregiver and researcher regarding the evolution and achievement of goals by Goal Attainment Scaling (GAS). | — |
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be motor development, assessed by the Alberta Infant Motor Scale (AIMS), Gross Motor Function Measure (GMFM) and Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT), mobility domain. | — |
Countries
Brazil
Contacts
Public ContactTatiane Schlichting
Universidade Federal de São Carlos - UFSCAR
Outcome results
None listed