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COMPLETED
NCT03866694
NA

Growing Together: Women in Opioid Treatment and Their Infants

Sponsor: Boston University Charles River Campus

View on ClinicalTrials.gov

Summary

This study evaluates the effectiveness of the home-based therapeutic parenting intervention BRIGHT with pregnant women and postpartum mothers with opioid use disorders (OUDs) and their infants. It examines whether participation in the BRIGHT intervention improves parent-child relationships, parenting capacities, the mother's overall mental health, participation in OUD treatment, infant social-emotional development and decreases the likelihood of child maltreatment. Approximately half of the participants will receive the BRIGHT intervention, monthly handouts, and the standard of care at the maternal-fetal medical clinic and the other half will receive STAR, or Enhanced Treatment as Usual (TAU+), which includes monthly handouts and the standard of care from the medical clinic.

Official title: Growing Together: A Pragmatic Clinical Trial of a Parenting Intervention for Women in Opioid Treatment and Their Infants

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2018-12-13

Completion Date

2022-03-31

Last Updated

2026-07-20

Healthy Volunteers

No

Interventions

BEHAVIORAL

BRIGHT

Dyadic therapeutic parenting intervention (BRIGHT) beginning in third trimester of pregnancy through six months postpartum focusing on child-parent relationship, mental health, infant social-emotional development, and recovery. Monthly handouts for mothers in recovery with information about child development and recovery from substance misuse while parenting and the standard of care at participant's high risk maternal-fetal medical clinic.

OTHER

STAR/TAU+

Monthly handouts for mothers in recovery with information about child development and recovery from substance misuse while parenting and the standard of care at participant's high risk maternal-fetal medical clinic

Locations (1)

Boston Medical Center

Boston, Massachusetts, United States