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Completed

NCT Number: NCT05746507

Night Respite for Postpartum Mothers With SUD

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Entre Familia Residential Treatment Program, Mattapan, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Night Respite Care

Behavioral

(see description above)

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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

    Measurement of total sleep using actigraphy device in a 24hr period

  2. 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)

    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.

  3. 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)

    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.

  4. 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)

    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.

  5. 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)

    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

  6. 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)

    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.

  7. 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)

    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.

  8. 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)

    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.

  9. 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)

    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.

  10. 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)

    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.

  11. 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)

    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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Pilot Feasibility of Night Respite Care for Postpartum Mothers With Substance Use Disorder in Residential Treatment Programs

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2023
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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