RESPECT-PLUS: Services for Infants With Prenatal Opiate Exposure

NCT02334111 | Completed

• 1 other identifier: HHS-2012-ACF-ACYF-CB-0286
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The impact of parental opioid use disorder and other substance use exposure on child welfare and the healthcare system is undeniable. Between 2000 and 2009, the number of delivering mothers using or dependent on opiates rose nearly five-fold, and it is estimated that 48-94% of children exposed to opioids in utero will be diagnosed with neonatal abstinence syndrome (NAS), a set of behavioral and physiological complications resulting from abrupt substance withdrawal at birth. Opioid abuse is usually coupled with use of other substances, and research has demonstrated that children born to parents with substance use disorders are three to four times more likely to suffer abuse or neglect. Currently, the standard of care for pregnant women who are being treated for opiate dependence at Boston Medical Center (BMC) is to receive all their prenatal care in the RESPECT Clinic, an innovative program of the BMC Department of Obstetrics and Gynecology designed to treat addiction during the prenatal and early postnatal period. Once the child is born, BMC staff files a report of suspected child abuse and neglect in accordance with the Massachusetts General Laws section 51A. The state Department of Children and Families makes a determination regarding the disposition of these families. Medically, most of these children are treated in-patient at BMC for NAS and then discharged to follow-up with routine pediatric primary care. Currently, approximately 85% of infants born exposed to opioids go home with their mothers, and the remainder receive substitute care, either with other family members or via foster care. This investigation is a randomized controlled trial of RESPECT-Plus, a continuum of promising and evidence-based practices designed to strengthen family protective factors and improve health permanency and well-being outcomes for children born to mothers in treatment for opioid use disorder. Anticipated outcomes of the intervention include fewer reports of supported child abuse or neglect filings in the child's first year of life, fewer days in out-of-home placement; fewer terminations of parental rights in the child's first year of life; and improvements in family functions overall (e.g. improved access to basic needs/social determinants of health, improved parental resilience, and decreased maternal depression).

Conditions

Opioid Use Disorder; Neonatal Abstinence Syndrome; Child Development; Child Abuse; Child Neglect

Keywords

Parenting Support for Mothers in Recovery; Neonatal Abstinence Syndrome; Social Determinants of Health; Child Development; Child Abuse; Child Neglect; Primary Care

Outcome Measures

Primary Outcomes (1)

• Time to Change in Custody

  Child welfare data will be obtained for all enrolled infant subjects from the Department of Children and Families (DCF). DCF will provide information concerning any changes in custody. The study outcome will be time to change in custody as primary outcome.

  up to 12 months post-birth

Secondary Outcomes (1)

• Improvements in parental resilience and parenting aligned with the Strengthening Families model (parental resilience, knowledge of parenting and child development, concrete supports, social connections, and child well-being)

  Outcomes will be measured at baseline, 6 months, and 12 months (child-related measures only administered at 6 and 12 months post-birth)

Other Outcomes (1)

• Process Data

  Measures will be taken at 6 and 12 months

Study Arms (2)

(Control)

NO INTERVENTION

Patients will receive standard of care

(Intervention)

EXPERIMENTAL

Patients will receive RESPECT-Plus intervention

Behavioral: RESPECT-Plus

Interventions

RESPECT-Plus BEHAVIORAL

A RESPECT-Plus family specialist (FS) will deliver the intervention to subjects (mothers in treatment for opiate use disorder) recruited during their third trimester of pregnancy and randomized into the study's intervention arm post-delivery. During their infant's hospital stay, the FS will schedule a convenient time to meet the subjects (mothers) to educate them on infant soothing techniques. With permission from the mother, the FS will join the subjects during their infant's routine well-child visits at the pediatric primary site. Optional home visiting provides another meeting opportunity between the subjects and FS.

(Intervention)

Eligibility Criteria

• Age: Up to 21 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Opiate-dependent pregnant women receiving opiate-replacement therapy (methadone or buprenorphine) treatment by licensed provider (mother)
• Receives prenatal and obstetric care through Boston Medical Center's RESPECT clinic (mother)
• Due date within 3 months at time of enrollment (Estimated Gestation Age \>27 weeks) (mother)
• years and older (mother)
• Singleton pregnancy (infant)
• Intends to deliver at Boston Medical Center (mother)
• Intends to remain in the Boston area after birth of child (mother)
• Mother able to provide informed consent (not excluded by RESPECT staff)
• No serious medical illness in infant such as sepsis, asphyxia, seizures, or respiratory failure (infant)
• No major congenital abnormalities in infant including genetic syndromes (infant)
• Gestational age at birth 36 weeks or greater defined by obstetrical estimate (infant)
• Born at Boston Medical Center (infant)
• Not incarcerated at the time of enrollment (mother)

You may not qualify if:

• Plans to voluntarily relinquish parental rights at birth
• Does not speak English.
• Estimated gestational age less than 36 weeks
• Infant positive for serious congenital anomaly or developmental disability

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02445, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Neonatal Abstinence Syndrome

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ruth Rose-Jacobs, Sc.D.

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: January 8, 2015
• Study Start: July 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 16, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)