Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04700059 |
| Other study ID # |
IRB18-0533 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2020 |
| Est. completion date |
February 28, 2023 |
Study information
| Verified date |
June 2022 |
| Source |
Massachusetts General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 offspring abuse among adolescent mothers in Perú, a middle-income country with
high rates of childhood physical and sexual abuse, IPV, and adolescent pregnancy.
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 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.
