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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

Study Summary

This trial looks at overnight care for babies of moms with substance use disorder, in order to help them build parenting skills.

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.Check my eligibility

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.See study design

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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through three months following intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and through three months following intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Recruitment and Enrollment

Study Acceptability

Study Feasibility

Secondary outcome measures

Ability to fall asleep

Filings for child abuse/neglect

Maternal mental health - Anxiety

+12 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,933 Previous Clinical Trials

13,198,446 Total Patients Enrolled

Davida M Schiff, MDPrincipal InvestigatorMassachusetts General Hospital

Media Library

Night Respite Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05746507 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the expected outcomes of this experiment?

"This study aims to evaluate the feasibility of a particular intervention over a three month timeline. Secondary objectives include assessing insomnia severity via Insomnia Sleep Index, measuring sleep quality with Single Item Sleep Quality Scale, and Postpartum Sleep Quality by way of Postpartum Sleep Quality Scale."

Answered by AI

Is the research team currently recruiting participants for this experiment?

"As indicated on clinicaltrials.gov, this medical trial is currently recruiting participants. The study was posted online in December of 2022 and updated as recently as February 2023."

Answered by AI

What is the uppermost capacity of participants for this experiment?

"Affirmative. As outlined on clinicaltrials.gov, this research is currently recruiting participants. It was initially posted on December 20th 2022 and has since been updated on February 25th 2023 with a target of 25 patients from 2 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Night Respite for Postpartum Mothers With SUD

Davida M. Schiff, MD 2022. "Night Respite for Postpartum Mothers With SUD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05746507.