Child DevelopmentNCT04362098
A Home Visiting Program for Pregnant Youth to Promote Early Brain Development II
A study testing Home visiting Program for Young Pregnant Women in people with Child Development, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Home visiting programs for pregnant women aiming to improve mother-infant relationship has received worldwide attention in the past 30 years. These programs are considered an important strategy to improve women's health during pregnancy, aside from improving child's birthing conditions and allowing parents access to… Read more about this study
- Who is it for?
- Ages 14 to 20 years, women only
- Conditions the study is for
- Child Development
- What is being tested?
- Home visiting Program for Young Pregnant Women
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteBrazil
- Study dates
- 13 Jun 2018to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 20 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Low socioeconomic status
- Mother's age between 14-19
- Mother being a primapara
- Gestation between the 8th and 16th week
Who cannot join
- High-risk gestation
- Mother's Intellectual, visual or auditory disability
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05403010
About this study
Official title: The Effects Over Early Brain Development of a Nurse Home Visitation Program for Pregnant Youth and Their Families Living in a Poor Urban Area in São Paulo, Brazil II
Home visiting programs for pregnant women aiming to improve mother-infant relationship has received worldwide attention in the past 30 years. These programs are considered an important strategy to improve women's health during pregnancy, aside from improving child's birthing conditions and allowing parents access to tools which will nurture and properly stimulate their baby, thus promoting emotional and cognitive development. Objectives: The "Nurse home visitation program for pregnant youth" aims to promote infant´s healthy development, from pregnancy to the first months of life, in a high-risk population. Methods: Eighty young pregnant women aged between 14 and 21 years were randomly allocated to the intervention or to usual prenatal care program. The "Nurse home visitation program for pregnant youth" was developed based on Albert Bandura's theory of self-efficacy, on Urie Bronfenbrenner´s bioecological model, which recognizes the importance of individual and family inclusion in various contexts of social life, on John Bowlby and Mary Ainsworth evolutionary theories of attachment, which involves the care practitioner addressing issues such as environmental health, life course and parenting, bond between mother and infant, and infant´s social and cognitive development. Neuropsychomotor development will be assessed at 3, 6, 12 and 24 months using the Bayley Scale of Infant Development. Brain development will be assessed via electroencephalography at 6, 12 and 24 months.
- Conditions
- Child Development
- Being tested
- Home visiting Program for Young Pregnant Women
- Keywords
- Child Development, Infant, Mother-Child Relations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home visiting Program for Young Pregnant WomenBehavioural
The visitation program was elaborated based in the following theoretical principles: a) Albert Bandura's self-efficacy theory; b) Urie Brofenbrenner's bioecological theory, which recognizes the importance of the insertion of individuals in families in varied contexts of life in society; c) John Bowlby and Mary Ainsworth's attachment theory. The basic premises of the intervention are health care, environmental health, life course development, development of parenting ability, relationship with friends and family, and social service support.
| Study group | Role | What they receive |
|---|---|---|
| Nurse home visits | Experimental | Nurse home visits biweekly. Receives: Behavioral: Home visiting Program for Young Pregnant Women |
| Usual care | No intervention | Usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neuropsychomotor Development During First Year of Life: Cognition
Complete child assessment with the Bayley Scale of Infant Development at 3, 6 and 12 months of age.
Measured: From 3 to 12 months of age
Change in Neuropsychomotor Development During First Year of Life: Receptive Language
Child assessment with the Bayley Scale of Infant Development.
Measured: From 3 to 12 months of age
Change in Neuropsychomotor Development During First Year of Life: Expressive Language
Child assessment with the Bayley Scale of Infant Development
Measured: From 3 to 12 months of age
Change in Neuropsychomotor Development During First Year of Life: Fine Motor
Child assessment with the Bayley Scale of Infant Development, fine motor scale.
Measured: From 3 to 12 months of age
Change in Neuropsychomotor Development During First Year of Life: Gross Motor
Child assessment with the Bayley Scale of Infant Development
Measured: From 3 to 12 months of age
Secondary outcomes (2)
Change in Child Brain Maturation
Assessment of brain wave patterns (alpha, gamma and theta frequencies) via electroencephalography (EEG).
Measured: At 6 and 12 months
Mother-child Attachment Biomarker
Assessment of event-related potential associated with child face recognition of the mother via electroencephalography (EEG).
Measured: At 6 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 posted24 Apr 2020
- Study start13 Jun 2018
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guilherme Vanoni Polanczyk, MD PhD, University of Sao Paulo
- Investigators
- Guilherme V Polanczyk, PhD, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362098
- Sponsor's protocol ID
- 2016/22455-8
- Other IDs
- 2016
- Status last verified
- Apr 2020
- First submitted
- 22 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Over Early Brain Development of a Nurse Home Visitation Program for Pregnant Youth and Their Families Living in a Poor Urban Area in São Paulo, Brazil II
- ClinicalTrials.gov ID
- NCT04362098
- Acronym / sponsor ID
- 2016/22455-8
- Conditions
- Child Development
- Keywords
- Child Development, Infant, Mother-Child Relations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 167 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 24 Apr 2020 (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.
Home visiting programs for pregnant women aiming to improve mother-infant relationship has received worldwide attention in the past 30 years. These programs are considered an important strategy to improve women's health during pregnancy, aside from improving child's birthing conditions and allowing parents access to tools which will nurture and properly stimulate their baby, thus promoting emotional and cognitive development. Objectives: The "Nurse home visitation program for pregnant youth" aims to promote infant´s healthy development, from pregnancy to the first months of life, in a high-risk population. Methods: Eighty young pregnant women aged between 14 and 21 years were randomly allocated to the intervention or to usual prenatal care program. The "Nurse home visitation program for pregnant youth" was developed based on Albert Bandura's theory of self-efficacy, on Urie Bronfenbrenner´s bioecological model, which recognizes the importance of individual and family inclusion in various contexts of social life, on John Bowlby and Mary Ainsworth evolutionary theories of attachment, which involves the care practitioner addressing issues such as environmental health, life course and parenting, bond between mother and infant, and infant´s social and cognitive development. Neuropsychomotor development will be assessed at 3, 6, 12 and 24 months using the Bayley Scale of Infant Development. Brain development will be assessed via electroencephalography at 6, 12 and 24 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse home visits | Experimental | Behavioral: Home visiting Program for Young Pregnant WomenNurse home visits biweekly. |
| Usual care | No intervention | –Usual care. |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Low socioeconomic status
- Mother's age between 14-19
- Mother being a primapara
- Gestation between the 8th and 16th week
Key exclusion criteria (2 listed)
- High-risk gestation
- Mother's Intellectual, visual or auditory disability
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 |
|---|---|---|
| Home visiting Program for Young Pregnant WomenThe visitation program was elaborated based in the following theoretical principles: a) Albert Bandura's self-efficacy theory; b) Urie Brofenbrenner's bioecological theory, which recognizes the importance of the insertion of individuals in families in varied contexts of life in society; c) John Bowlby and Mary Ainsworth's attachment theory. The basic premises of the intervention are health care, environmental health, life course development, development of parenting ability, relationship with friends and family, and social service support. | Behavioural | Nurse home visits |
Primary outcome
Change in Neuropsychomotor Development During First Year of Life: Cognition
Time frame: From 3 to 12 months of age
Complete child assessment with the Bayley Scale of Infant Development at 3, 6 and 12 months of age.
Change in Neuropsychomotor Development During First Year of Life: Receptive Language
Time frame: From 3 to 12 months of age
Child assessment with the Bayley Scale of Infant Development.
Change in Neuropsychomotor Development During First Year of Life: Expressive Language
Time frame: From 3 to 12 months of age
Child assessment with the Bayley Scale of Infant Development
Change in Neuropsychomotor Development During First Year of Life: Fine Motor
Time frame: From 3 to 12 months of age
Child assessment with the Bayley Scale of Infant Development, fine motor scale.
Change in Neuropsychomotor Development During First Year of Life: Gross Motor
Time frame: From 3 to 12 months of age
Child assessment with the Bayley Scale of Infant Development
2 secondary outcomes
Change in Child Brain Maturation
Time frame: At 6 and 12 months
Mother-child Attachment Biomarker
Time frame: At 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
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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. This study is not recruiting at the moment.
Guilherme V Polanczyk, PhD study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home visiting Program for Young Pregnant Women in people with Child Development, run by University of Sao Paulo at 1 site in Brazil.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Apr 2020. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neuropsychomotor Development During First Year of Life: Cognition (time frame: From 3 to 12 months of age). The study lists 5 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 24 Apr 2020.