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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 and Enrollment

    Time frame: Through study completion up to 3 months

    Total number of individuals approached, consented, and enrolled in the study

  2. Study Feasibility

    Time frame: Through three months following intervention period

    Count of total number individuals completing intervention and retained through study follow up

  3. Study Acceptability

    Time frame: Through three months following intervention period

    Feedback in semi-structured interviews with participants and key stakeholders

Secondary outcomes

  1. Maternal sleep quantity

    Time frame: Through three months following intervention

    Measurement of total nightly sleep using actigraphy device

  2. Ability to fall asleep

    Time frame: Through three months following intervention

    Insomnia Sleep Index (Measured on a scale of 0-28)

  3. Sleep quality

    Time frame: Through three months following intervention

    Single Item Sleep Quality Scale;

  4. Postpartum Sleep Quality

    Time frame: Through three months following intervention

    Postpartum Sleep Quality Scale

  5. Maternal mental health - Depression

    Time frame: Through three months following intervention

    Patient Health Questionnaire-8

  6. Maternal mental health - Anxiety

    Time frame: Through three months following intervention

    General Anxiety Disorder-7

  7. Medication for Addiction Treatment Retention

    Time frame: Through three months following intervention

    Continuation of medication for addiction treatment

  8. Substance use treatment retention

    Time frame: Through three months following intervention

    Retention in residential treatment program

  9. Recovery Capitol

    Time frame: Through three months following intervention

    Brief Assessment of Recovery Capitol (BARC-10)

  10. Parental stress

    Time frame: Through three months following intervention

    Parenting Stress Index

  11. Parental bonding

    Time frame: Through three months following intervention

    Postpartum Bonding Questionnaire;

  12. Parental self-efficacy

    Time frame: Through three months following intervention

    Perceived Parenting Self-Efficacy Questionnaire

  13. Social Support

    Time frame: Through three months following intervention

    Postpartum Social Support Scale

  14. Unnecessary unscheduled healthcare utilization

    Time frame: Through three months following intervention

    ED and Urgent care visits attended

  15. Filings for child abuse/neglect

    Time frame: Through three months following intervention

    51A-filings for child abuse or neglect to MA DCF

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
Jan 16, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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