Family Intervention to Improve Maternal and Child Mental Health
Family Intervention to Improve Maternal and Child Mental Health
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 offspring abuse among adolescent mothers in Perú, a middle-income country with
 high rates of childhood physical and sexual abuse, IPV, and adolescent pregnancy.
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 conducted using structured questionnaires that cover questions about
 socio-demographic characteristics, lifestyle characteristics, symptoms of depression or PTSD,
 history of trauma, and medical, obstetric and psychiatric history. Participants will be able
 to enter their responses online, with a research team member available to answer questions by
 phone, or they can give their answers by phone while a team member enters them. See attached
 Initial Questionnaire for details.

 After the interview, each participant will be asked to provide the name of someone whom she
 anticipates will be helping her to care for the child. We expect that in most cases this will
 be a female relative of the participant, typically her mother or grandmother, but it may also
 be a friend or the baby's father. The participant will be given information about the study
 to provide to the other caregiver, and the interviewer will contact the other caregiver
 within a week of enrolling the participant and arrange for a convenient time for the
 caregiver to learn about the study and go through the informed consent procedures. If more
 than one person is providing significant support to the mother, she may identify up to two
 other caregivers. She can also identify a second caregiver at a later point.

 Each participating family will be randomized to either the intervention arm or the usual care
 arm. Usual care consists of routine prenatal care and pediatric follow up at 2 weeks, 2
 months, 4 months and 6 months. If enrolled prior to 20 weeks gestation, participants in both
 groups will receive a short phone call to check in every 4 weeks, until they reach 24 weeks
 gestation, to minimize the gap before the first visit at 28 weeks.

 After delivery, obstetric records will be reviewed for information about gestational age,
 birth weight, and any complications. See attached Birth Data form for planned data
 collection.

 Due to COVID-19, the intervention will begin with virtual visits conducting via
 videoconferencing. If, during the study period, it becomes safe to do home visits, we may
 switch to in-person home visits, or we may conduct the entire study with virtual visits. The
 intervention consists of 2 prenatal and 8 postpartum visits, with visit frequency gradually
 decreasing as mothers gain experience and confidence. Visits will last for up to 90 minutes
 to allow time for multiple caregivers to participate. Other caregivers will be encouraged to
 participate for the first 10 minutes and the last 20 minutes of the intervention sessions. As
 much as possible, visits will accommodate the family schedule, occurring at a time when all
 or most of the caregivers are at home. The perspectives of all caregivers will be elicited by
 the home visitor in order to facilitate a conversation among them about their preferences,
 concerns, and goals.

 After completion of either the intervention or the control condition, the adolescent mothers
 will repeat the questionnaires about demographics, as well as anxiety, depression, PTSD and
 trauma history. If COVID-19 precautions are still necessary during this phase of the study,
 the post-intervention questionnaires will be completed in the same manner as the initial
 questionnaires, with data entered online with the support of the research team by phone. See
 attached Post-intervention Questionnaire for details. Interactions between the mother and
 infant, other caregiver and infant, and all three together will be video recorded and coded
 to assess caregiver sensitivity. If COVID-19 precautions are still necessary, these
 assessments will be conducted using video conferencing, and the video calls will be recorded
 and coded in the manner described. These recordings will be assessed and coded across five
 dimensions: "physical involvement," "verbal involvement," "responsiveness," "positive
 statements," and "control over child's activities," each rated 0-5 for the "quality" and
 "appropriateness" of caregiver behavior (Cooper et al., 2009; Farran, Kasari, Comfort, & Jay,
 1986). Finally, the Still Face Paradigm will be conducted in which the mother-infant dyads
 will perform a video recorded 3-minute face-to-face interaction consisting of 1 minute
 normal, 1 minute still-face, and 1 minute reunion after still-face. Maternal behavior will be
 scored for sensitivity during normal and reunion phases (scored 0-5) (Murray, Fiori-Cowley,
 Hooper, & Cooper, 1996); infants will be scored for regulatory behavior (Braungart-Rieker,
 Garwood, Powers, & Wang, 2001; Murray & Trevarthen, 1985; Tronick & Weinberg, 1994) and
 dysregulated behavior, including gaze aversion, facial expression, crying, and agitated
 movement during each 1-second interval (Gunning, Halligan, & Murray, 2013).

 We will record only what is necessary for the research record and take all steps necessary to
 blur/obscure the images of those who have not consented to the research and/or to being
 recorded or photographed. All interview guides and other study materials not currently
 available will be submitted to the IRB for approval prior to use.
Inclusion Criteria:

 -  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 Criteria:

 -  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.