Status:
UNKNOWN
Family Intervention to Improve Maternal and Child Mental Health
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Instituto Nacional Materno Perinatal
Hospital San Bartolome
Conditions:
Adolescent Pregnancy
Eligibility:
All Genders
14+ years
Phase:
NA
Brief Summary
This pilot study will assess the acceptability, feasibility and efficacy of a family-based intervention to improve maternal and child mental health by increasing maternal sensitivity and decreasing of...
Detailed Description
Participants will be recruited from the prenatal clinics at INMP and San Bartolomé. Due to COVID-19, the prenatal clinics are currently conducting only telehealth visits. The interviews will be conduc...
Eligibility Criteria
Inclusion
- All subjects must be able to read and write Spanish.
- RCT will be limited to pregnant adolescents who are between the ages of 14-19 years and 12-34 weeks gestational age. Other caregivers (age 14 years or older) will be eligible if they are planning to be involved in infant care.
- Only pregnant adolescents receiving outpatient prenatal care at INMP or San Bartolomé will be approached as potential participants.
- Only pregnant adolescents who have been cleared by their attending doctor/nurse to engage in the approach/recruitment and interview procedure will be approached as potential participants.
- All infants born to adolescents enrolled during pregnancy will be eligible to be enrolled after birth.
Exclusion
- Anyone unable to read and write Spanish.
- Any pregnant adolescent known to have a severe fetal anomaly will not be approached.
- Infants who are advised not to participate by their attending doctor or pediatrician.
- Children or adolescents who are wards of the state will not be enrolled.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04700059
Start Date
December 1 2020
End Date
February 28 2023
Last Update
June 9 2022
Active Locations (1)
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1
Instituto Nacional Materno Perinatal
Lima, Peru