Child DevelopmentNCT02807818
A Home Visiting Program for Pregnant Youth to Promote Early Brain Development
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 19 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
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2015to Dec 2018
- 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 19 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 on Early Brain Development of a Nurse Home Visitation Program for Pregnant Youth and Their Families Living in a Poor Urban Area in Sao Paulo, Brazil
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 20 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 and 12 months using the Bayley Scale of Infant Development. Brain development will be assessed via electroencephalography at 6 and 12 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
| Study group | Role | What they receive |
|---|---|---|
| Nurse home visits | Experimental | Nurse biweekly home visit. 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
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
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 posted21 Jun 2016 (estimated)
- Study startJun 2015
- Primary completionSep 2018
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guilherme Vanoni Polanczyk, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807818
- Sponsor's protocol ID
- 0722-03
- Status last verified
- Oct 2018
- First submitted
- 9 Jun 2016
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
da Silva LA, Siqueira LD, Oliveira LGF, Miguel Filho EC, Polanczyk GV, Fracolli LA. The impact of a home visiting program on the care environment of Brazilian adolescent mothers - an descriptive exploratory study. Front Glob Womens Health. 2025 Apr 25;6:1530351. doi: 10.3389/fgwh.2025.1530351. eCollection 2025.
PubMed 40351759Euclydes VLV, Gastaldi VD, Feltrin AS, Hoffman DJ, Gouveia G, Cogo H, Felipe-Silva A, Vieira RP, Miguel EC, Polanczyk GV, Chiesa A, Fracolli L, Matijasevich A, Ferraro A, Argeu A, Maschietto M, Brentani HP. DNA methylation mediates a randomized controlled trial home-visiting intervention during pregnancy and the Bayley infant's cognitive scores at 12 months of age. J Dev Orig Health Dis. 2022 Oct;13(5):556-565. doi: 10.1017/S2040174421000738. Epub 2022 Mar 8.
PubMed 35256034Fatori D, Fonseca Zuccolo P, Shephard E, Brentani H, Matijasevich A, Archanjo Ferraro A, Aparecida Fracolli L, Chiesa AM, Leckman J, Constantino Miguel E, V Polanczyk G. A randomized controlled trial testing the efficacy of a Nurse Home Visiting Program for Pregnant Adolescents. Sci Rep. 2021 Jul 13;11(1):14432. doi: 10.1038/s41598-021-93938-7.
PubMed 34257407Alarcao FSP, Shephard E, Fatori D, Amavel R, Chiesa A, Fracolli L, Matijasevich A, Brentani H, Nelson CA, Leckman J, Miguel EC, Polanczyk GV. Promoting mother-infant relationships and underlying neural correlates: Results from a randomized controlled trial of a home-visiting program for adolescent mothers in Brazil. Dev Sci. 2021 Nov;24(6):e13113. doi: 10.1111/desc.13113. Epub 2021 Apr 12.
PubMed 33844435Fatori D, Argeu A, Brentani H, Chiesa A, Fracolli L, Matijasevich A, Miguel EC, Polanczyk G. Maternal Parenting Electronic Diary in the Context of a Home Visit Intervention for Adolescent Mothers in an Urban Deprived Area of Sao Paulo, Brazil: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Jul 28;8(7):e13686. doi: 10.2196/13686.
PubMed 32720906
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects on Early Brain Development of a Nurse Home Visitation Program for Pregnant Youth and Their Families Living in a Poor Urban Area in Sao Paulo, Brazil
- ClinicalTrials.gov ID
- NCT02807818
- Acronym / sponsor ID
- 0722-03
- Conditions
- Child Development
- Keywords
- Child development, Infant, Mother-Child Relations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Dec 2018 (estimated)
- First posted
- 21 Jun 2016 (estimated)
- 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 20 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 and 12 months using the Bayley Scale of Infant Development. Brain development will be assessed via electroencephalography at 6 and 12 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 biweekly home visit. |
| Usual care | No intervention | –Usual care. |
Who may qualify
- Ages
- 14 to 19 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 Women | Behavioural | Nurse home visits |
Primary outcome
Change in neuropsychomotor development during first year of life
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.
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 15 Oct 2018.
- Derived from this study: PubMed 40351759da Silva LA, Siqueira LD, Oliveira LGF, Miguel Filho EC, Polanczyk GV, Fracolli LA. The impact of a home visiting program on the care environment of Brazilian adolescent mothers - an descriptive exploratory study. Front Glob Womens Health. 2025 Apr 25;6:1530351. doi: 10.3389/fgwh.2025.1530351. eCollection 2025.
- Derived from this study: PubMed 35256034Euclydes VLV, Gastaldi VD, Feltrin AS, Hoffman DJ, Gouveia G, Cogo H, Felipe-Silva A, Vieira RP, Miguel EC, Polanczyk GV, Chiesa A, Fracolli L, Matijasevich A, Ferraro A, Argeu A, Maschietto M, Brentani HP. DNA methylation mediates a randomized controlled trial home-visiting intervention during pregnancy and the Bayley infant's cognitive scores at 12 months of age. J Dev Orig Health Dis. 2022 Oct;13(5):556-565. doi: 10.1017/S2040174421000738. Epub 2022 Mar 8.
- Derived from this study: PubMed 34257407Fatori D, Fonseca Zuccolo P, Shephard E, Brentani H, Matijasevich A, Archanjo Ferraro A, Aparecida Fracolli L, Chiesa AM, Leckman J, Constantino Miguel E, V Polanczyk G. A randomized controlled trial testing the efficacy of a Nurse Home Visiting Program for Pregnant Adolescents. Sci Rep. 2021 Jul 13;11(1):14432. doi: 10.1038/s41598-021-93938-7.
- Derived from this study: PubMed 33844435Alarcao FSP, Shephard E, Fatori D, Amavel R, Chiesa A, Fracolli L, Matijasevich A, Brentani H, Nelson CA, Leckman J, Miguel EC, Polanczyk GV. Promoting mother-infant relationships and underlying neural correlates: Results from a randomized controlled trial of a home-visiting program for adolescent mothers in Brazil. Dev Sci. 2021 Nov;24(6):e13113. doi: 10.1111/desc.13113. Epub 2021 Apr 12.
- Derived from this study: PubMed 32720906Fatori D, Argeu A, Brentani H, Chiesa A, Fracolli L, Matijasevich A, Miguel EC, Polanczyk G. Maternal Parenting Electronic Diary in the Context of a Home Visit Intervention for Adolescent Mothers in an Urban Deprived Area of Sao Paulo, Brazil: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Jul 28;8(7):e13686. doi: 10.2196/13686.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 15 Oct 2018. 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 (time frame: From 3 to 12 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02807818, which also lists 5 linked publications.
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 15 Oct 2018.