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Developmental assessment and stimulation of children at risk

Assessment of child development and early intervention in high-risk children and their families in Brazil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6ct969
Enrollment
Unknown
Registered
2016-12-14
Start date
2015-01-15
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

child development, Depression Postpartum, parental stress, mother-child relationship, parental believes and practices on child care

Interventions

A longitudinal program of psicossocial intervention was developed with a focus on strengthening mother-child interaction, reducing parental stress and maternal depression, and encouraging childcare pr
Behavioural
N02.421.143.130.320
G07.700.320

Sponsors

Universidade Federal de Minas Gerais/Prof. Claudia Regina Lindgren Alves
Lead Sponsor
Hospital Sofia Feldman
Collaborator

Eligibility

Age
0 Months to 2 Months

Inclusion criteria

Inclusion criteria: They will be admitted newborns included in the House of the Hospital Sofia Feldman baby during the period of conducting the survey; which remained for at least three days in the House of Baby; whose families are willing to participate in the stages of this project and signed the term of free and informed consent.

Exclusion criteria

Exclusion criteria: Children whose parents did not sign the consent form and clear; whose mothers died at birth; whose mothers have mental disorders that compromise their understanding or following your child; with diagnosed sensory disabilities; with malformation of the nervous system or the locomotor system; neurogenic diseases or chromosomal disorders diagnosed, the presence of hypoxic-ischemic lesions (multicystic encephalomalacia or periventricular leukomalacia) diagnosed.

Design outcomes

Primary

MeasureTime frame
Child Development evaluated by the total score in the Bayley Child Development Scale 3rd Edition (Bayley-III), applied at 4, 6, 9 and 12 months of age. Bayley-III is a standardized test with a mean score of 100 and a standard deviation of 15. Score lower than 1 standard deviation below the mean is suggestive of developmental delay. The test has 3 subscales to obtain measures of language, motor and cognitive development. Controlling for the initial performance level, it is expected that at the end of the study: (a) the intervention group will present mean scores in each area significantly higher than the controls, and (b) statistical modeling should indicate a lower chance of developmental delay, in the different areas, in the intervention group.

Secondary

MeasureTime frame
Parental stress assessed by the Index of Symptoms of Stress Lipp (ISSL), in the newborn period, and Parental Stress Index (PSI), at the end of the program. It is expected that, at 12 months, the mothers mean stress' level will be significantly lower in the intervention group ;Maternal depression assessed using the Edinburgh Postpartum Depression Scale (EDPS) applied during visit of 2 e 9 months, where the effect of the intervention will be checked by comparing the average scores of the control group and intervention group. It is expected that at the end of the program, lower number of mothers in the intervention group will show signs of depression.;Beliefs Evaluation and Parenting Practices (E-CCP) applied in the initial contact with the mother and visit 9 months, where the effect of the intervention will be checked by comparing the average scores of the control group and intervention group. It is expected that, at the end of the program, mother of the intervention group will present greater number of adequate parental practices.;Mother-child interaction through the analysis of video clips of the parent-child interaction during the presentation of a "new toy" as scored by the Parenting Interactions with Children -Checklist of Observations Linked to Outcomes (PICCOLO). The the effect of the intervention will be verified by comparing groups on the number of positive behaviors observed during mother-child interaction. It is expected that, at the end of the programa, mothers in the intervention group will show significantly higher number of positive interactions.

Countries

Brazil

Contacts

Public ContactClaudia Regina;Lívia Alves;Magalhães

Universidade Federal de Minas Gerais/Prof. Claudia Regina Lindgren Alves;Escola de Educação Física, Fisioterapia e Terapia Ocupacional- Universidade Federal de Minas Gerais-UFMG

lindgrenalves@gmail.com;liviacmag@gmail.com+55(31)3409-9773;+55(31)3409-4781

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 24, 2026