Growing Together: Women in Opioid Treatment and Their Infants
NCT ID: NCT03866694
Last Updated: 2020-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2018-12-13
2021-12-30
Brief Summary
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Detailed Description
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BRIGHT has been offered to young children ages birth through 6 years and their parents affected by substance use disorders (SUDs) to mitigate the effects of trauma, promote resilience, and enhance the quality of parent-child relationships and parenting skills. BRIGHT has been successfully piloted and evaluated within residential treatment and outpatient opioid treatment programs for pregnant women/mothers with SUDs and OUDs with young children .
For this study, BRIGHT has been adapted for home-based delivery for pregnant women receiving treatment for OUDs and is offered from the 3rd trimester of pregnancy until the infant is about 6 months old. Participants in both arms will be recruited from a high-risk maternal-fetal medicine clinic and followed for approximately 15 months. The two arms of the trial are 1) the BRIGHT (Building Resilience through Intervention, Growing Healthier Together) intervention, and 2) STAR. Both arms of the study will receive the typical standard of care of at a high-risk maternal-fetal medical clinic and 7 monthly psycho-educational handouts on child development specifically for mothers in recovery.
The investigators are testing the effectiveness of the adapted version of BRIGHT by utilizing measures to examine if participation in BRIGHT decreases the likelihood of child maltreatment, improves parent-child relationships, parenting capacities, the mother's overall mental health, participation in OUD treatment, and infant social-emotional development.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BRIGHT
Building Resilience through Intervention: Growing Healthier Together (BRIGHT) weekly home-based intervention from the third trimester of pregnancy through 6 months postpartum. A licensed clinician meets with mother and infant to promote attunement and optimal parent-child interactions. Additionally, the mother receives monthly handouts focused on information about child development and recovery from substance misuse while parenting, along with the standard of care at a high risk maternal-fetal medical clinic
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.
STAR/TAU+
The mother receives monthly handouts focused on information about child development and recovery from substance misuse while parenting, along with the standard of care at a high risk maternal-fetal medical clinic.
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
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
* 18 years orolder
* Being treated with methadone, naltrexone, or suboxone
* In 3rd trimester of pregnancy
* Deemed by MDs able to give informed consent
* Planning to parent infant after birth
* Willing to participate in RCT
Exclusion Criteria
* Residing, or expected to reside post-birth 20+ miles from Boston
* Deemed by MDs unable to give informed consent
18 Years
FEMALE
No
Sponsors
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Health Resources and Services Administration (HRSA)
FED
Institute for Health and Recovery (IHR)
UNKNOWN
Boston University
OTHER
Boston University Charles River Campus
OTHER
Responsible Party
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Ruth Paris
Associate Professor
Principal Investigators
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Ruth Paris, PhD
Role: PRINCIPAL_INVESTIGATOR
Boston University
Locations
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Boston Medical Center
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Ruth Rose-Jacobs, ScD, MS
Role: primary
Other Identifiers
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R40MC31764
Identifier Type: -
Identifier Source: org_study_id
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