Growing Together: Women in Opioid Treatment and Their Infants

NCT03866694 | Unknown

• 1 other identifier: R40MC31764
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Coding Interactive Behavior (CIB) system (Observer-rated parent-infant video), measuring Maternal Sensitivity (representing the parent-child relationship)

  CIB is a rating of mother-child interactions which has three 5-point Likert subscales: Maternal Sensitivity (MSense, primary outcome), Maternal intrusiveness (MIntrude), and Child involvement. (CInvolve). High scores on CIB scales indicate more evidence of the behavior/dimension. Moderate scores typically indicate presence of the behavior/dimension approximately 50% of the time. Low scores indicate that the behavior/dimension is never/infrequently observed. The CIB has been validated with healthy and at-risk populations. The study is assessing the change in CIB score between the time points.

  t1 (6-8 Weeks postpartum), t2 (6-8 months postpartum)

• The Adult- Adolescent Parenting Inventory-2 (AAPI), measuring the Risk of Child Maltreatment

  Responses to the inventory provide an index of risk for practicing behaviors known to be attributable to child abuse and neglect. Answers are recorded on a scale from Strongly Agree to Strongly Disagree. Subscales include: Construct A - Inappropriate Expectations of Children, Construct B - Parental Lack of Empathy Towards Children's Needs, Construct C - Strong Parental Belief in the Use of Corporal Punishment, Construct D - Reversing Parent-Child Family Roles, Construct E - Oppressing Children's Power and Independence. 32-item inventory assessing parenting and child-rearing attitudes associated with risk for child maltreatment. Five parenting interaction constructs include, 1) inappropriate expectations for child, 2) empathic awareness of child's needs, 3) belief in corporal punishment, 4) role reversal and 5) oppressing children's power. Construct validity is well-established. Test-re-test reliability is .76. The study is assessing the change in AAPI score between the time points.

  t1 (6-8 weeks postpartum), t2 (6-8 months postpartum), t3 (9-11 months postpartum)

Secondary Outcomes (10)

• Karitane Parenting Confidence Scale (KPCS), measuring Parenting Capacity

  t1 (6-8 weeks postpartum), t2 (6-8 months postpartum), t3 (9-11 months postpartum)

• Parenting Stress Index/Short Form (PSI/SF), measuring Parenting Capacity

  t1 (6-8 weeks postpartum), t2 (6-8 months postpartum), t3 (9-11 months postpartum)

• The Parental Reflective Functioning Questionnaire (PRFQ), measuring Parenting Capacity

  t1 (6-8 weeks postpartum), t2 (6-8 months postpartum), t3 (9-11 months postpartum)

• The Brief Symptom Inventory (BSI), measuring Maternal Mental Health (including continuation of OUD treatment)

  t0 (3rd trimester), t1 (6-8 weeks postpartum), t2 (6-8 months postpartum)

• The Life Stressor Checklist- Revised (LSC-R), measuring Maternal Mental Health (including continuation of OUD treatment)

  t0 (3rd trimester)

Study Arms (2)

BRIGHT

EXPERIMENTAL

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

Behavioral: BRIGHT

STAR/TAU+

ACTIVE COMPARATOR

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.

Other: STAR/TAU+

Interventions

BRIGHT BEHAVIORAL

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.

BRIGHT

STAR/TAU+ OTHER

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+

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A patient at BUMC RESPECT clinic with history of opioid use or history of polysubstance use
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• Health Resources and Services Administration (HRSA): collaborator
• Institute for Health and Recovery (IHR): collaborator
• Boston University: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Ruth Paris, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Short, MSW

CONTACT

617-358-2368; growrct@bu.edu

Ruth Paris, PhD

CONTACT

617-353-7717; rparis@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking is used in this clinical trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: March 7, 2019
• Study Start: December 13, 2018
• Primary Completion: March 31, 2021
• Study Completion: December 30, 2021
• Last Updated: July 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)