Adolescent PregnancyMCMHNCT04700059
Family Intervention to Improve Maternal and Child Mental Health
A study testing Virtual perinatal home visiting in people with Adolescent Pregnancy, run by Massachusetts General Hospital at 1 site in Peru.
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… Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adolescent Pregnancy
- What is being tested?
- Virtual perinatal home visiting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 sitePeru
- Study dates
- 1 Dec 2020to 28 Feb 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptation and Assessment of a Family Intervention Designed to Improve Maternal and Child Mental Health in a Resource-limited Setting
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.
Read the 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 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.
- Conditions
- Adolescent Pregnancy
- Being tested
- Virtual perinatal home visiting
- Keywords
- Perinatal intervention, Intergenerational trauma
- Medical subject headings
- Historical Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual perinatal home visitingBehavioural
10 perinatal home visits
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 10 perinatal home visits Receives: Behavioral: Virtual perinatal home visiting |
| Usual care | No intervention | Routine medical care for mother and infant. Access to online resources. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional availability scales
Video recorded coded assessment of caregiver and infant interaction
Measured: 6 months after birth
Secondary outcomes (3)
PHQ-9
Maternal depression
Measured: At enrollment and 6 months after birth
GAD-7
Maternal anxiety
Measured: At enrollment and 6 months after birth
PCL-C
Maternal PTSD
Measured: At enrollment and 6 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start1 Dec 2020
- Primary completion31 Aug 2022 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent PregnancyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional Materno Perinatal, Hospital San Bartolome, AC PROESA
- Responsible party
- Principal investigator, Elizabeth Levey, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700059
- Sponsor's protocol ID
- IRB18-0533
- Acronym
- MCMH
- Status last verified
- Jun 2022
- First submitted
- 5 Jan 2021
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Assessment of a Family Intervention Designed to Improve Maternal and Child Mental Health in a Resource-limited Setting
- ClinicalTrials.gov ID
- NCT04700059
- Acronym / sponsor ID
- MCMH / IRB18-0533
- Conditions
- Adolescent Pregnancy
- Keywords
- Perinatal intervention, Intergenerational trauma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Instituto Nacional Materno Perinatal, Hospital San Bartolome, AC PROESA
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 7 Jan 2021 (actual)
- 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.
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.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Virtual perinatal home visiting10 perinatal home visits |
| Usual care | No intervention | –Routine medical care for mother and infant. Access to online resources. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Virtual perinatal home visiting10 perinatal home visits | Behavioural | Intervention |
Primary outcome
Emotional availability scales
Time frame: 6 months after birth
Video recorded coded assessment of caregiver and infant interaction
3 secondary outcomes
PHQ-9
Time frame: At enrollment and 6 months after birth
GAD-7
Time frame: At enrollment and 6 months after birth
PCL-C
Time frame: At enrollment and 6 months after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Individual participant dataSharing planned: No
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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 Virtual perinatal home visiting in people with Adolescent Pregnancy, run by Massachusetts General Hospital at 1 site in Peru.
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 5 inclusion and 4 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 9 Jun 2022. 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 Peru. 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?
Emotional availability scales (time frame: 6 months after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2022.