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NCT02334111 · ClinicalTrials.gov registry record · NA
RESPECT-PLUS: Services for Infants With Prenatal Opiate Exposure
A NA study, sponsored by Boston Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 200
- Enrollment target
NCT02334111: Completed NA study, sponsored by Boston Medical Center.
NCT02334111 is a NA study that has completed, run by Boston Medical Center. The registered enrollment target is 200 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02334111, a NA study, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
Study 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 a
Primary Outcome
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.
Interventions
- BEHAVIORAL RESPECT-Plus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2013-07 |
| Est. Completion | 2016-09 |
| Phase | NA |
What the finished NCT02334111 record still lists
NCT02334111 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which RESPECT-Plus is the first listed.
NCT02334111 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02334111 about?
NCT02334111 is a clinical study titled "RESPECT-PLUS: Services for Infants With Prenatal Opiate Exposure". 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 op...
What is the current status of trial NCT02334111?
This trial is currently completed. It is a NA study. The enrollment target is 200 participants. The study started on 2013-07. Estimated completion is 2016-09.
What interventions are being tested in trial NCT02334111?
The interventions under investigation include: RESPECT-Plus (BEHAVIORAL).
Who is sponsoring clinical trial NCT02334111?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02334111's enrollment target sits among peer trials
200 506th of 2000 higher than 1,434 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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