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Night Respite Care for Postpartum Mothers with Substance Use Disorder
N/A
Recruiting
Led By Davida M Schiff, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through three months following intervention
Awards & highlights
No Placebo-Only Group
Summary
This trial provides babysitting and baby care education to new mothers with substance use disorders in residential treatment. Experts take care of the babies and teach the mothers about baby behavior. The goal is to help these mothers rest and learn how to better care for their newborns.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves non-medical interventions like night respite care and parenting education, traditional side effects associated with medications are not applicable. However, there may be emotional or psychological impacts from participating.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through three months following intervention period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through three months following intervention period
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Recruitment and Enrollment
Study Acceptability
Study Feasibility
Secondary study objectives
Ability to fall asleep
Filings for child abuse/neglect
Maternal mental health - Anxiety
+12 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Night Respite CareExperimental Treatment1 Intervention
18 overnight night respite care sessions over six weeks with parental skills provided through teachable moments before and after respite care supports
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Opioid Use Disorder (OUD) include pharmacological and psychosocial interventions. Medications like methadone, buprenorphine, and naltrexone work by interacting with opioid receptors in the brain to reduce cravings and withdrawal symptoms.
Methadone and buprenorphine are opioid agonists that activate these receptors to a lesser degree, while naltrexone is an antagonist that blocks opioid effects. Psychosocial treatments, such as Cognitive Behavioral Therapy (CBT) and family therapy, focus on changing behaviors and thought patterns related to substance use.
These combined approaches are essential for addressing both the physiological and psychological aspects of addiction, thereby improving the chances of long-term recovery. This is particularly relevant for programs like Overnight Infant Respite Care and Parenting Skills, which aim to reduce stress and enhance caregiving abilities, supporting the overall well-being of mothers with OUD.
Family in pediatric obesity management: a literature review.
Family in pediatric obesity management: a literature review.
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Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,785 Total Patients Enrolled
Davida M Schiff, MDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.