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Raising children and dreams: randomized clinical trial in a tertiary hospital

Raising children and dreams

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3z4dd72
Enrollment
Unknown
Registered
2025-02-08
Start date
2024-10-22
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

Pregnancy in adolescence

Interventions

This is a two-arm, parallel, randomized controlled experimental study with open masking. Pregnant teenagers aged 14 to 19 years old who are in the second trimester, between 14 and 28 weeks of gestatio
N01.400.075 SP2.770.750.323

Sponsors

Universidade Estadual de Campinas
Lead Sponsor
Universidade Estadual de Campinas
Collaborator

Eligibility

Sex/Gender
Female
Age
14 Years to 19 Years

Inclusion criteria

Inclusion criteria: Pregnant teenager; aged 14 to 19 years old; who is in the second trimester between 14 and 28 weeks of gestation; and who undergoes prenatal care at Centro de Atenção Integral à Saúde da Mulher e do Recém-nascido - CAISM/UNICAMP

Exclusion criteria

Exclusion criteria: Pregnant teenager who has difficulty reading, writing and understanding questionnaires; pregnant teenager who does not have access to and availability of the internet or cell phone

Design outcomes

Primary

MeasureTime frame
The adolescents will answer the instrument Assessment of the mother-baby bond in the postpartum period - PBQ at the birth review and three months after birth. Considering the average score of 5.5 for the control group and the improvement in the score of 2.5 for the intervention group with a standard deviation of 2.01, we will have a number of 15 for each group. We considered a 50% improvement in the bond between the binomial, comparing the groups. Hopes to improve the bond between teenage mother and child, according to remote intervention

Secondary

MeasureTime frame
The adolescents will answer the Rosenberg self-esteem scale and the Connor-Davidson Resilience scale at three and six months postpartum. They will also participate in a return to school interview. The percentage of adolescents who no longer attend school after pregnancy is 68.3%, rising to 85.7% in the third trimester of pregnancy. Considering 68% of school dropouts and that the intervention program will increase school retention to 50%, the number must be 53 participants for each group. To have clinical superiority, the number must be 80 participants in each group. Adolescents are expected to have a medium and long-term life project and return to the school environment and/or the job market after 6 months postpartum, according to remote intervention and motivational interviewing

Countries

Brazil

Contacts

Public ContactMarielle Carvalho

Universidade Estadual de Campinas

marielle@unicamp.br+55-19-35219333

Outcome results

None listed

Source: REBEC (via WHO ICTRP)