Growing Together: Women in Opioid Treatment and Their Infants
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/9/2019 |
| Start Date: | December 13, 2018 |
| End Date: | December 30, 2021 |
| Contact: | Ashley Short, MSW |
| Email: | growrct@bu.edu |
| Phone: | 617-358-2368 |
Growing Together: A Pragmatic Clinical Trial of a Parenting Intervention for Women in Opioid Treatment and Their Infants
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.
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.
Growing Together is a two-armed pragmatic randomized controlled trial of a trauma and
evidence-informed therapeutic parenting intervention, BRIGHT. This trial lasts approximately
9 months.
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.
evidence-informed therapeutic parenting intervention, BRIGHT. This trial lasts approximately
9 months.
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.
Inclusion Criteria:
- A patient at BUMC RESPECT clinic with history of opioid use or history of
polysubstance use
- 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:
- Planning to relinquish custody of neonate
- Residing, or expected to reside post-birth 20+ miles from Boston
- Deemed by MDs unable to give informed consent
We found this trial at
1
site
Click here to add this to my saved trials
