Clinical trial NCT03866694: Growing Together: Women in Opioid Treatment and Their Infants
Official title: Growing Together: A Pragmatic Clinical Trial of a Parenting Intervention for Women in Opioid Treatment and Their Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Substance-Related Disorders
Keywords: maternal opioid use
substance use
parent-child relationship
parenting
social and emotional development
mental health and well-being
perinatal
postpartum
health disparities
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
name: Institute for Health and Recovery (IHR)
name: Boston University
First posted: 2019-03-07
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants in this randomized controlled trial are assigned to one of two groups, BRIGHT or STAR. BRIGHT is a therapeutic parenting intervention that begins in the third trimester of pregnancy and continues through six months postpartum. BRIGHT and STAR receive the standard of care at a high risk maternal-fetal medical clinic and 7 psycho-educational handouts over the course of the study.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Coding Interactive Behavior (CIB) system (Observer-rated parent-infant video), measuring Maternal Sensitivity (representing the parent-child relationship)
timeFrame: t1 (6-8 Weeks postpartum), t2 (6-8 months postpartum)
measure: The Adult- Adolescent Parenting Inventory-2 (AAPI), measuring the Risk of Child Maltreatment
timeFrame: t1 (6-8 weeks postpartum), t2 (6-8 months postpartum), t3 (9-11 months postpartum)
Secondary outcomes:
measure: Karitane Parenting Confidence Scale (KPCS), measuring Parenting Capacity
timeFrame: t1 (6-8 weeks postpartum), t2 (6-8 months postpartum), t3 (9-11 months postpartum)
measure: Parenting Stress Index/Short Form (PSI/SF), measuring Parenting Capacity
timeFrame: t1 (6-8 weeks postpartum), t2 (6-8 months postpartum), t3 (9-11 months postpartum)
measure: The Parental Reflective Functioning Questionnaire (PRFQ), measuring Parenting Capacity
timeFrame: t1 (6-8 weeks postpartum), t2 (6-8 months postpartum), t3 (9-11 months postpartum)
measure: The Brief Symptom Inventory (BSI), measuring Maternal Mental Health (including continuation of OUD treatment)
timeFrame: t0 (3rd trimester), t1 (6-8 weeks postpartum), t2 (6-8 months postpartum)
measure: The Life Stressor Checklist- Revised (LSC-R), measuring Maternal Mental Health (including continuation of OUD treatment)
timeFrame: t0 (3rd trimester)
measure: Connor-Davidson Resilience Scale-10 (CD-RISC 10), measuring Maternal Mental Health (including continuation of OUD treatment)
timeFrame: t0 (3rd trimester), t1 (6-8 weeks postpartum), t2 (6-8 months postpartum)
measure: Post Traumatic Stress Disorder Checklist (PCL-5), measuring Maternal Mental Health (including continuation of OUD treatment)
timeFrame: t0 (3rd trimester), t1 (6-8 weeks postpartum), t2 (6-8 months postpartum)
measure: Addiction Severity Index (ASI), measuring Maternal Mental Health (including continuation of OUD treatment)
timeFrame: t0 (3rd trimester), t1 (6-8 weeks postpartum), t2 (6-8 months postpartum)
measure: Devereaux Early Childhood Assessment for Infants and Toddlers (DECA-I/T), measuring Infant Social-Emotional Development
timeFrame: t1 (6-8 weeks postpartum), t2 (6-8 months postpartum), t3 (9-11 months postpartum)
measure: Parent Development Interview (PDI)- Short Form Revised 2016, measuring Parental Reflective Functioning
timeFrame: t0 (3rd trimester), t2 (6-8 months postpartum)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Ruth Paris, PhD
role: PRINCIPAL_INVESTIGATOR
References: