Opioid Use DisorderNCT05746507
Night Respite for Postpartum Mothers With SUD
A study testing Night Respite Care in people with Opioid Use Disorder and Maternal Drugs Affecting Fetus, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
This single arm pilot feasibility study will evaluate the implementation of overnight infant respite care and parenting skills to mothers with substance use disorders in the early postpartum period residing in residential substance use disorder treatment programs. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Opioid Use Disorder, Maternal Drugs Affecting Fetus, Postpartum Mood Disturbance
- What is being tested?
- Night Respite Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Dec 2022to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caring for an infant under 12 months of age.
- Being the primary caretaker for their infant.
- Having a DSM-5 diagnosis of a substance use disorder.
- Currently residing in a participating residential treatment program or private home setting
- English-speaking or Spanish-speakers with limited English proficiency
Who cannot join
- Having an untreated serious mental health illness.
- Having an untreated substance use disorder or existing concerns that this person is actively using substances.
- Having a history of prior violence or intimate partner violence in the home.
- Provider concern regarding instability or lack of information about home safety.
- Not actively parenting an infant under 12 months of age
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Entre Familia Residential Treatment Program
Mattapan, Massachusetts, 02126
New Day Residential Treatment Program
Somerville, Massachusetts, 02143
About this study
Official title: Pilot Feasibility of Night Respite Care for Postpartum Mothers With Substance Use Disorder in Residential Treatment Programs
This single arm pilot feasibility study will evaluate the implementation of overnight infant respite care and parenting skills to mothers with substance use disorders in the early postpartum period residing in residential substance use disorder treatment programs.
Read the detailed description
This single arm pilot feasibility study will evaluate the implementation of overnight infant respite care provided approximately 3 nights per week for 6 weeks (18 nights total) to each of 20 - 25 mothers with substance use disorders in the early postpartum period residing in residential substance use disorder treatment programs. Overnight respite care will last for eight hours, with one hour reserved each morning to provide teaching about infant-specific temperament and cues. The program is a unique public/private/academic partnership with the Massachusetts Department of Children and Families (DCF), Boston Baby Nurse and Nanny (BBNN), two residential treatment programs, and Massachusetts General Hospital.
Partnering with BBNN, Newborn Care Experts interested in providing respite care to families impacted by SUD will be paired with postpartum families residing in two residential treatment programs in the Boston area. New Day in Somerville, MA and Entre Familia in Mattapan, MA will partner with MGH to recruit individuals to complete a screening and baseline intake, receive night respite care, and complete a follow up study visit at the completion of the intervention and at 3 months post intervention.
This study will use mixed methods to understand the feasibility and acceptability of the pilot intervention including experiences of this pilot program through the perspectives of program participants, respite care givers, residential treatment overnight staff, and study staff. Respite caregivers and residential treatment program staff will be invited to participate in interviews after each dyad receives their allotted hours of respite care to reflect on this program participant's specific experience.
BBNN, DCF, and residential treatment program leadership staff, will be invited to participate a focus group once at the completion of the study to understand the feasibility, acceptability, and implementation of this program through the lens of their organizations. They will also be invited to take a short survey aimed at assessing their perception of the intervention's appropriateness and feasibility.
- Conditions
- Opioid Use Disorder, Maternal Drugs Affecting Fetus, Postpartum Mood Disturbance, Sleep Disorder, Neonatal Opioid Withdrawal
- Being tested
- Night Respite Care
- Medical subject headings
- Opioid-Related Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Night Respite CareBehavioural
(see description above)
| Study group | Role | What they receive |
|---|---|---|
| Night Respite Care | Experimental | 18 overnight night respite care sessions over six weeks with parental skills provided through teachable moments before and after respite care supports Receives: Behavioral: Night Respite Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Number of individuals who study consent AND completed screening and baseline, this being eligible to start intervention
Measured: Period from signing study consent form to completing screening and baseline, ranged from 1d to several weeks, on average less than a week
Participation in Intervention
Reciept of any nights of respite care during the intervention period
Measured: Completion of consent and screening/baseline through end of intervention period, approximately 6 weeks
Study Feasibility
Count of total number individuals completing intervention and retained through study follow up
Measured: At completion of the intervention, up to six weeks following the completion
Study Acceptability
Feedback in semi-structured interviews with participants
Measured: At completion of the intervention, up to six weeks after last night of respite.
Secondary outcomes (11)
Maternal Sleep Quantity
Measurement of total sleep using actigraphy device in a 24hr period
Measured: Measurement began between 1 week and 1 day before starting respite and continued until at least one day after respite care ended, maximum of 8 weeks
Ability to Fall Asleep
Insomnia Sleep Index (Measured on a scale of 0-28). Insomnia symptoms were assessed using a brief insomnia symptom score capturing difficulty initiating sleep, maintaining sleep, and sleep satisfaction. Higher scores indicate greater insomnia severity. This measure was analyzed as a single continuous outcome reflecting insomnia symptom burden.
Measured: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
Sleep Quality
Single Item Sleep Quality Scale; Overall perceived sleep quality was assessed using a single-item self-report measure asking participants to rate their global sleep quality over a recent time period. Higher scores reflect better perceived sleep quality. Single-item sleep quality measures have demonstrated sensitivity to change and strong correlations with multi-item sleep scales in postpartum populations.
Participants rate their overall sleep quality using a single-item self-report measure. Scores range from 0 to 10, where 0 = terrible sleep quality and 10 = excellent sleep quality. Higher scores indicate better perceived sleep quality.
Measured: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
Postpartum Sleep Quality
Postpartum-specific sleep quality was measured using the Postpartum Sleep Quality Scale is a caregiver-reported measure of postpartum sleep quality. The PSQS includes the following subscales:
Infant-Related Sleep Disruption subscale: range 0-42 Physical Symptoms subscale: range 0-42 Total PSQS score: range 0-84, calculated by summing item responses across subscales.
For all PSQS scores, higher values indicate worse postpartum sleep quality and greater sleep burden.
Measured: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
Maternal Mental Health - Depression
Patient Health Questionnaire-8: Depressive symptoms were measured using the PHQ-8, an 8-item self-report scale assessing core symptoms of depression over the past two weeks. Items are scored from 0 ("not at all") to 3 ("nearly every day"), with total scores ranging from 0 to 24. The PHQ-8 is a unidimensional measure and is widely used in postpartum and population-based studies. A higher score indicates greater degree of depressive symptoms
Measured: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
Maternal Mental Health - Anxiety
Anxiety symptoms were assessed using the GAD-7, a validated 7-item self-report measure of generalized anxiety symptoms over the past two weeks. Items are scored on a 0-3 Likert scale, yielding a total score ranging from 0 to 21, with higher scores indicating greater anxiety severity. The GAD-7 is unidimensional and has demonstrated strong reliability and validity in perinatal populations.
Measured: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
Recovery Capitol
The BARC-10 is a 10-item self-report measure assessing personal, social, and community resources that support recovery from substance use disorder. Each item is scored from 1 to 6 and summed to create a total score.
Total score range: 10-60
Higher scores indicate greater recovery capital and a better recovery-related outcome. The scale is analyzed as a single total score.
Measured: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
Parental Stress
Parenting Stress Index-Short Form (PSI-SF). The PSI-SF is a 36-item caregiver-reported measure that yields three subscale scores and a Total Stress Score:
Parental Distress (PD): range 12-60 Parent-Child Dysfunctional Interaction (P-CDI): range 12-60 Difficult Child (DC): range 12-60 Total Stress Score: range 36-180, calculated as the sum of the three subscales
Higher scores indicate greater parenting stress and a worse outcome.
Measured: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
Parental Bonding
Postpartum Bonding Questionnaire (PBQ); The PBQ is a 25-item caregiver-reported measure assessing disturbances in the parent-infant relationship. It includes the following subscales:
Impaired Bonding: range 0-60 Rejection and Anger: range 0-36 Infant-Focused Anxiety: range 0-20 Risk of Abuse: range 0-12 Total PBQ score: range 0-100, calculated by summing all items
Higher scores indicate greater bonding difficulties and a worse outcome.
Measured: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
Parental Self-efficacy
Parenting self-efficacy was measured using the Perceived Maternal Parenting Self-Efficacy Scale, a multi-item self-report instrument assessing caregivers' confidence in their parenting skills and ability to manage parenting tasks.
The Perceived Maternal Parenting Self-Efficacy Scale is a 20-item self-report measure assessing caregivers' confidence in their parenting abilities and performance of parenting tasks.
Total score range: 20-80 (20 items scored 1-4 and summed)
Higher scores indicate greater parenting self-efficacy and a better outcome. The scale is analyzed as a total score.
Measured: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
Social Support
Perceived social support in the postpartum period was assessed using the Postpartum Social Support Screening tool, a caregiver-reported measure evaluating emotional, instrumental, and informational support. The scale includes multiple items and is commonly analyzed as a total score reflecting overall perceived support. There are 9 total questions that range from 1 (none of the time) to 5 (all of the time) and the total score is summed. The scores can range from 9-45 and and high score indicate higher postpartum social support.
Measured: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start20 Dec 2022
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Overnight infant respite care provided approximately 3 nights per week for 6 weeks (18 nights total) lasting eight hours per night. Overnight respite care will last for eight hours, with one hour reserved to provide teaching about infant-specific temperament and cues.
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Davida M. Schiff, MD, Massachusetts General Hospital
- Investigators
- Davida M Schiff, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746507
- Sponsor's protocol ID
- 2025P001377
- Other IDs
- K23DA048169
- Status last verified
- Aug 2026
- First submitted
- 15 Feb 2023
- Last updated
- 11 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility of Night Respite Care for Postpartum Mothers With Substance Use Disorder in Residential Treatment Programs
- ClinicalTrials.gov ID
- NCT05746507
- Acronym / sponsor ID
- 2025P001377
- Conditions
- Opioid Use Disorder, Maternal Drugs Affecting Fetus, Postpartum Mood Disturbance, Sleep Disorder, Neonatal Opioid Withdrawal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Posted 11 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single arm pilot feasibility study will evaluate the implementation of overnight infant respite care and parenting skills to mothers with substance use disorders in the early postpartum period residing in residential substance use disorder treatment programs.
Detailed description
This single arm pilot feasibility study will evaluate the implementation of overnight infant respite care provided approximately 3 nights per week for 6 weeks (18 nights total) to each of 20 - 25 mothers with substance use disorders in the early postpartum period residing in residential substance use disorder treatment programs. Overnight respite care will last for eight hours, with one hour reserved each morning to provide teaching about infant-specific temperament and cues. The program is a unique public/private/academic partnership with the Massachusetts Department of Children and Families (DCF), Boston Baby Nurse and Nanny (BBNN), two residential treatment programs, and Massachusetts General Hospital.
Partnering with BBNN, Newborn Care Experts interested in providing respite care to families impacted by SUD will be paired with postpartum families residing in two residential treatment programs in the Boston area. New Day in Somerville, MA and Entre Familia in Mattapan, MA will partner with MGH to recruit individuals to complete a screening and baseline intake, receive night respite care, and complete a follow up study visit at the completion of the intervention and at 3 months post intervention.
This study will use mixed methods to understand the feasibility and acceptability of the pilot intervention including experiences of this pilot program through the perspectives of program participants, respite care givers, residential treatment overnight staff, and study staff. Respite caregivers and residential treatment program staff will be invited to participate in interviews after each dyad receives their allotted hours of respite care to reflect on this program participant's specific experience.
BBNN, DCF, and residential treatment program leadership staff, will be invited to participate a focus group once at the completion of the study to understand the feasibility, acceptability, and implementation of this program through the lens of their organizations. They will also be invited to take a short survey aimed at assessing their perception of the intervention's appropriateness and feasibility.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Overnight infant respite care provided approximately 3 nights per week for 6 weeks (18 nights total) lasting eight hours per night. Overnight respite care will last for eight hours, with one hour reserved to provide teaching about infant-specific temperament and cues.
| Arm | Type | Receives |
|---|---|---|
| Night Respite Care | Experimental | Behavioral: Night Respite Care18 overnight night respite care sessions over six weeks with parental skills provided through teachable moments before and after respite care supports |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Caring for an infant under 12 months of age.
- Being the primary caretaker for their infant.
- Having a DSM-5 diagnosis of a substance use disorder.
- Currently residing in a participating residential treatment program or private home setting
- English-speaking or Spanish-speakers with limited English proficiency
Key exclusion criteria (5 listed)
- Having an untreated serious mental health illness.
- Having an untreated substance use disorder or existing concerns that this person is actively using substances.
- Having a history of prior violence or intimate partner violence in the home.
- Provider concern regarding instability or lack of information about home safety.
- Not actively parenting an infant under 12 months of age
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 |
|---|---|---|
| Night Respite Care(see description above) | Behavioural | Night Respite Care |
Primary outcome
Recruitment
Time frame: Period from signing study consent form to completing screening and baseline, ranged from 1d to several weeks, on average less than a week
Number of individuals who study consent AND completed screening and baseline, this being eligible to start intervention
Participation in Intervention
Time frame: Completion of consent and screening/baseline through end of intervention period, approximately 6 weeks
Reciept of any nights of respite care during the intervention period
Study Feasibility
Time frame: At completion of the intervention, up to six weeks following the completion
Count of total number individuals completing intervention and retained through study follow up
Study Acceptability
Time frame: At completion of the intervention, up to six weeks after last night of respite.
Feedback in semi-structured interviews with participants
11 secondary outcomes
Maternal Sleep Quantity
Time frame: Measurement began between 1 week and 1 day before starting respite and continued until at least one day after respite care ended, maximum of 8 weeks
Ability to Fall Asleep
Time frame: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
Sleep Quality
Time frame: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
Postpartum Sleep Quality
Time frame: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
Maternal Mental Health - Depression
Time frame: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
Maternal Mental Health - Anxiety
Time frame: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
Recovery Capitol
Time frame: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
Parental Stress
Time frame: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
Parental Bonding
Time frame: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
Parental Self-efficacy
Time frame: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
Social Support
Time frame: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Davida M Schiff, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Night Respite Care in people with Opioid Use Disorder and Maternal Drugs Affecting Fetus, run by Massachusetts General Hospital at 2 sites 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 5 inclusion and 5 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 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 11 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Recruitment (time frame: Period from signing study consent form to completing screening and baseline, ranged from 1d to several weeks, on average less than a week). The study lists 4 primary outcomes in all. 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 11 Sep 2026.