Night Respite Care for Postpartum Mothers with Substance Use Disorder

No longer recruiting at 1 trial location

Overseen By Davida M Schiff, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Untreated mental illness, Untreated substance use, Violence history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 20

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the benefits of overnight infant care for new mothers dealing with substance use issues. The focus is on providing night respite care, offering mothers a break by caring for their infants overnight, and teaching parenting skills during these times. The trial seeks mothers who are the primary caretakers of babies under 12 months old, have a diagnosed substance use disorder, and reside in specific treatment centers. As an unphased trial, this study offers a unique opportunity for mothers to receive support and learn valuable skills in a supportive environment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that Night Respite Care is safe for postpartum mothers with substance use disorder?

Research shows that night respite care is a supportive service, not a medication, so it lacks the same safety concerns as drugs. It provides overnight care for infants, allowing postpartum mothers with substance use disorders to rest.

Previous studies have found that such programs can improve family functioning and help mothers feel more supported. This approach is part of broader efforts to assist mothers in residential treatment programs for substance use disorders. Although specific data on negative events related to night respite care itself is lacking, the main goal is to create a safe, supportive environment for both mothers and their infants.

Even without detailed safety data, since this isn't a drug, the care aims to offer a positive and supportive experience. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike typical treatments for postpartum mothers with substance use disorder, which often focus on medication-assisted therapy or outpatient counseling, Night Respite Care offers a different approach. This method provides 18 overnight sessions designed to give mothers much-needed rest while helping them develop parental skills through teachable moments. Researchers are excited because this approach not only addresses the immediate need for rest but also integrates skill-building, potentially leading to more sustainable recovery outcomes. By combining respite care with practical parenting support, this treatment aims to tackle both the physical exhaustion and the parenting challenges these mothers face, setting it apart from traditional methods.

What evidence suggests that Night Respite Care is effective for postpartum mothers with substance use disorder?

Research shows that overnight infant respite care, provided to participants in this trial, can help new mothers with substance use issues enhance their parenting skills. Studies have found that treatments focusing on the whole family, including overnight care, improve family relationships. For mothers in residential treatment for substance use, these methods support successful recovery and help them retain custody of their children. Structured support and skill-building opportunities are linked to positive outcomes in maternal caregiving. Overall, evidence suggests that night respite care can effectively aid the recovery process for these mothers. ^{1 2 6 7 8}

Who Is on the Research Team?

Davida M Schiff, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for mothers with substance use disorders who are the primary caretakers of an infant under 12 months, living in a residential treatment program. They must speak English or have limited proficiency and be diagnosed with a substance use disorder. Mothers with untreated serious mental health issues, active substance use, violence history, or unsafe home environments cannot join.

Inclusion Criteria

I am currently caring for a baby under 1 year old.

You are the main person taking care of a baby.

You have been diagnosed with a substance use disorder according to the DSM-5.

Exclusion Criteria

You have a history of being violent or involved in domestic violence.

The healthcare provider is worried that your home might not be safe or that there isn't enough information about how safe your home is.

I am not currently caring for a baby under 12 months old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive overnight infant respite care approximately 3 nights per week for 6 weeks, with parental skills provided through teachable moments

6 weeks

18 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including feedback and various assessments

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Night Respite Care

Trial Overview

The study tests overnight infant respite care combined with parenting skills support for postpartum mothers with substance use disorders. It's a single-arm pilot study focusing on feasibility within residential treatment programs.

How Is the Trial Designed?

Group I: Night Respite Care Experimental Treatment 1 Intervention

18 overnight night respite care sessions over six weeks with parental skills provided through teachable moments before and after respite care supports

Night Respite Care is already approved in United States, European Union for the following indications:

Approved in United States as Respite Care for:

• Support for caregivers of infants whose mothers have substance use disorders

Approved in European Union as Respite Services for:

• General support for caregivers
• Temporary relief for families with special needs

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Pregnant and postpartum women with opioid use disorder (OUD) reported positive experiences with peer support specialists (PSS), highlighting their strong impact on recovery during treatment.

Participants suggested improvements for PSS interactions, such as clearer boundaries, indicating that while PSS are beneficial, there is room for enhancing the support they provide to better meet the needs of perinatal women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer support specialists and perinatal opioid use disorder: Someone that's been there, lived it, seen it. Fallin-Bennett, A., Elswick, A., Ashford, K.[2021]

The study followed 149 homeless mothers over 18 months and found that those in residential substance abuse treatment had lower dropout rates compared to those in nonresidential services.

Both residential and nonresidential groups showed improvements in alcohol and drug issues and housing stability, indicating that residential placements can enhance engagement in treatment programs for homeless mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eighteen-month follow-up data on a treatment program for homeless substance abusing mothers. Smith, EM., North, CS., Fox, LW.[2022]

A new model of care for pregnant women and mothers with substance use disorders emphasizes integrated, harm reduction, and person-centered approaches, based on insights from interviews with 38 service providers in Sydney, Australia.

Key challenges to implementing this model include the fragmentation of services and ensuring continuity of care, which are essential for promoting engagement and achieving positive outcomes for mothers and their children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a model of care for substance use in pregnancy and parenting services, Sydney, Australia: Service provider perspectives. Coupland, H., Moensted, ML., Reid, S., et al.[2022]

A study of a residential substance abuse treatment program for women and their children in rural South Carolina showed that women who completed the program had significantly reduced addiction severity and parental stress at 6 and 12 months post-discharge.

Children of these women also demonstrated improved emotional and behavioral functioning, indicating that such treatment programs can benefit both mothers and their children, supporting the need for inclusive care in substance use disorder treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parental stress and child behavioral outcomes following substance abuse residential treatment. Follow-up at 6 and 12 months. Killeen, T., Brady, KT.[2019]

There is a significant gap in addiction management for individuals during the postpartum period, as care often ends after pregnancy, leading to increased risks of substance use disorder recurrence and overdose deaths, which have become a leading cause of maternal mortality in the US.

The review highlights the need for effective interventions and strategies to support continued addiction care postpartum, emphasizing the importance of harm reduction and the integration of evidence-based services to improve outcomes for new mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to Support Engagement in Addiction Care Postpartum: Principles and Pitfalls. Mazel, S., Alexander, K., Cioffi, C., et al.[2023]

The planned point-of-care clinical trials (MOMs and INFANTs) aim to compare the effectiveness of buprenorphine versus methadone for treating opioid dependence in pregnant women and its impact on neonatal abstinence syndrome (NAS), involving approximately 370 and 284 participants respectively.

Preliminary research suggests that buprenorphine may lead to shorter hospital stays for infants suffering from NAS compared to traditional treatments like methadone, indicating a potential benefit in maternal and infant health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design considerations for point-of-care clinical trials comparing methadone and buprenorphine treatment for opioid dependence in pregnancy and for neonatal abstinence syndrome. Winhusen, T., Wilder, C., Wexelblatt, SL., et al.[2015]

The Family Rehabilitation Program (FRP) in New York City showed that mothers who completed or remained active in the program had higher rates of abstinence from drug use and lower cocaine levels in their hair after one year, compared to those who left early.

Participation in the FRP was associated with a stable rate of family cohesion, as the percentage of families with children out of their homes did not significantly increase, indicating the program's effectiveness in supporting families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of comprehensive services for crack-dependent mothers with newborns and young children. Magura, S., Laudet, A., Kang, SY., et al.[2015]

Out of 4370 women in substance use treatment, 39.6% were mothers, with many facing significant challenges such as housing problems and higher rates of opioid and crack-cocaine use compared to women without children.

The study emphasizes the importance of improving substance use services to better address the specific needs of mothers, particularly in encouraging them to disclose their parenting and childcare situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parental status and characteristics of women in substance use treatment services: Analysis of electronic patient records. Canfield, M., Norton, S., Downs, J., et al.[2021]

Pregnant and parenting women with opioid use disorder require comprehensive care that addresses their unique challenges, including trauma, stigma, and access to treatment, to improve their health and that of their children.

The Maternal Addiction Treatment, Education, and Research program has successfully provided a model of care that includes patient navigation, low-barrier medications, trauma-responsive therapy, and support services, which are essential for engaging these women in treatment and promoting family health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive and compassionate responses for opioid use disorder among pregnant and parenting women. Hand, DJ., Fischer, AC., Gannon, ML., et al.[2021]

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Night Respite for Postpartum Mothers With SUD

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