Opioid Use DisorderRESPECT-PlusNCT02334111
RESPECT-PLUS: Services for Infants With Prenatal Opiate Exposure
A study testing RESPECT-Plus in people with Opioid Use Disorder and Neonatal Abstinence Syndrome, run by Boston Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 21 days
- Conditions the study is for
- Opioid Use Disorder, Neonatal Abstinence Syndrome, Child Development
- What is being tested?
- RESPECT-Plus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
- 18 years and older (mother)
- Singleton pregnancy (infant)
- Intends to deliver at Boston Medical Center (mother)
Show all 13Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Project RESPECT-Plus: Recovery, Empowerment, Social Services, Prenatal Care, Education and Community Treatment-Plus
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).
Read the detailed description
Project RESPECT-Plus (Recovery, Empowerment, Social Services, Prenatal care, Education, and Community Treatment-Plus) is a randomized controlled trial 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. The target population for project RESPECT-Plus is pregnant women in treatment for opiate use disorder receiving prenatal care at BMC's RESPECT Clinic. A total of 200 subjects - 100 mothers - will be enrolled into the study and randomized post-partum to receive the intervention or standard of care, and will be followed for 1 year.
In order to provide continuity of care from the prenatal to pediatric primary care setting, participants receiving prenatal care at the RESPECT Clinic are recruited during their third trimester of pregnancy. After consent, the initial baseline data collection is scheduled and once the infants are born and pass the eligibility screening (term birth and no major congenital abnormalities or developmental disabilities), mothers and their infants are randomized into the intervention (RESPECT-Plus) or control (standard of care) group.
The intervention is delivered by a family specialist who, with the permission of the mother, will attend routine well-child visits so as to collaborate with providers in the child's medical home and parent through the medical visit. As desired by the mother, home visits, other face-to-face contacts, telephone calls, and text messages will assist in addressing social determinants of health, improve the mother's knowledge of child development and parenting, and link families to community resources to address existing concrete support needs. The family specialist will receive support and training by a licensed clinical social worker and the Medical-Legal Partnership, Boston (MLP Boston) to identify legal and social needs that may affect a child's health and development and to take action either by helping family members advocate for themselves, or by referring them to an appropriate public health, legal, or social service agency or resources.
Both the intervention and standard of care groups will be evaluated by research evaluators not associated with the intervention at baseline, and when the child is 6 and 12 months old.
The two goals and associated objectives for RESPECT-Plus are:
- To evaluate the RESPECT-Plus intervention, on improving child well-being, safety, and permanency outcomes.
- To evaluate family functioning aligned with the five protective factors in the Strengthening Families model (parental resilience, knowledge of parenting and child development, concrete supports, social connections, and child factors).
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 and 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
- Being tested
- RESPECT-Plus
- Keywords
- Parenting Support for Mothers in Recovery, Neonatal Abstinence Syndrome, Social Determinants of Health, Child Development, Child Abuse, Child Neglect, Primary Care
- Medical subject headings
- Opioid-Related Disorders, Neonatal Abstinence Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESPECT-PlusBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| (Control) | No intervention | Patients will receive standard of care |
| (Intervention) | Experimental | Patients will receive RESPECT-Plus intervention Receives: Behavioral: RESPECT-Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
This composite measure involves evaluating important factors associated with parenting. This will include the Edinburgh Post-natal Depression Scale, the Connor-Davidson Resilience Scale, the Difficult Life Circumstances Scale, the Inventory of Socially Supportive Behaviors, and additional measures to assess material hardships and access to public assistance programs.
Measured: Outcomes will be measured at baseline, 6 months, and 12 months (child-related measures only administered at 6 and 12 months post-birth)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startJul 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth Rose-Jacobs Sc.D., Boston Medical Center
- Investigators
- Ruth Rose-Jacobs, Sc.D., Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334111
- Sponsor's protocol ID
- HHS-2012-ACF-ACYF-CB-0286
- Acronym
- RESPECT-Plus
- Status last verified
- Jan 2017
- First submitted
- 15 Apr 2014
- Last updated
- 16 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project RESPECT-Plus: Recovery, Empowerment, Social Services, Prenatal Care, Education and Community Treatment-Plus
- ClinicalTrials.gov ID
- NCT02334111
- Acronym / sponsor ID
- RESPECT-Plus / HHS-2012-ACF-ACYF-CB-0286
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 8 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Project RESPECT-Plus (Recovery, Empowerment, Social Services, Prenatal care, Education, and Community Treatment-Plus) is a randomized controlled trial 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. The target population for project RESPECT-Plus is pregnant women in treatment for opiate use disorder receiving prenatal care at BMC's RESPECT Clinic. A total of 200 subjects - 100 mothers - will be enrolled into the study and randomized post-partum to receive the intervention or standard of care, and will be followed for 1 year.
In order to provide continuity of care from the prenatal to pediatric primary care setting, participants receiving prenatal care at the RESPECT Clinic are recruited during their third trimester of pregnancy. After consent, the initial baseline data collection is scheduled and once the infants are born and pass the eligibility screening (term birth and no major congenital abnormalities or developmental disabilities), mothers and their infants are randomized into the intervention (RESPECT-Plus) or control (standard of care) group.
The intervention is delivered by a family specialist who, with the permission of the mother, will attend routine well-child visits so as to collaborate with providers in the child's medical home and parent through the medical visit. As desired by the mother, home visits, other face-to-face contacts, telephone calls, and text messages will assist in addressing social determinants of health, improve the mother's knowledge of child development and parenting, and link families to community resources to address existing concrete support needs. The family specialist will receive support and training by a licensed clinical social worker and the Medical-Legal Partnership, Boston (MLP Boston) to identify legal and social needs that may affect a child's health and development and to take action either by helping family members advocate for themselves, or by referring them to an appropriate public health, legal, or social service agency or resources.
Both the intervention and standard of care groups will be evaluated by research evaluators not associated with the intervention at baseline, and when the child is 6 and 12 months old.
The two goals and associated objectives for RESPECT-Plus are:
- To evaluate the RESPECT-Plus intervention, on improving child well-being, safety, and permanency outcomes.
- To evaluate family functioning aligned with the five protective factors in the Strengthening Families model (parental resilience, knowledge of parenting and child development, concrete supports, social connections, and child factors).
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 and 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (Control) | No intervention | –Patients will receive standard of care |
| (Intervention) | Experimental | Behavioral: RESPECT-PlusPatients will receive RESPECT-Plus intervention |
Who may qualify
- Ages
- Up to 21 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- 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)
- 18 years and older (mother)
- Singleton pregnancy (infant)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RESPECT-PlusA 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. | Behavioural | (Intervention) |
Primary outcome
Time to Change in Custody
Time frame: up to 12 months post-birth
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.
1 secondary outcome
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)
Time frame: Outcomes will be measured at baseline, 6 months, and 12 months (child-related measures only administered at 6 and 12 months post-birth)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth Rose-Jacobs, Sc.D. principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RESPECT-Plus in people with Opioid Use Disorder and Neonatal Abstinence Syndrome, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Change in Custody (time frame: up to 12 months post-birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2017.