NCT04700059

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 offspring abuse among adolescent mothers in Perú, a middle-income country with high rates of childhood physical and sexual abuse, IPV, and adolescent pregnancy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 5, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

June 9, 2022

Status Verified

June 1, 2022

Enrollment Period

1.7 years

First QC Date

January 5, 2021

Last Update Submit

June 8, 2022

Conditions

Adolescent Pregnancy

Keywords

Perinatal interventionIntergenerational trauma

Outcome Measures

Primary Outcomes (1)

  • Emotional availability scales

    Video recorded coded assessment of caregiver and infant interaction

    6 months after birth

Secondary Outcomes (3)

  • PHQ-9

    At enrollment and 6 months after birth

  • GAD-7

    At enrollment and 6 months after birth

  • PCL-C

    At enrollment and 6 months after birth

Study Arms (2)

Intervention

EXPERIMENTAL

10 perinatal home visits

Behavioral: Virtual perinatal home visiting

Usual care

NO INTERVENTION

Routine medical care for mother and infant. Access to online resources.

Interventions

Virtual perinatal home visitingBEHAVIORAL

10 perinatal home visits

Intervention

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional Materno Perinatal

Lima, Peru

Location

MeSH Terms

Conditions

Historical Trauma

Condition Hierarchy (Ancestors)

Psychological TraumaStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychiatry

Study Record Dates

First Submitted

January 5, 2021

First Posted

January 7, 2021

Study Start

December 1, 2020

Primary Completion

August 31, 2022

Study Completion

February 28, 2023

Last Updated

June 9, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

PE(1)