NCT05746507

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

2.4 years

First QC Date

February 15, 2023

Last Update Submit

January 15, 2026

Conditions

Opioid Use DisorderMaternal Drugs Affecting FetusPostpartum Mood DisturbanceSleep DisorderNeonatal Opioid Withdrawal

Outcome Measures

Primary Outcomes (3)

  • Recruitment and Enrollment

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

    Through study completion up to 3 months

  • Study Feasibility

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

    Through three months following intervention period

  • Study Acceptability

    Feedback in semi-structured interviews with participants and key stakeholders

    Through three months following intervention period

Secondary Outcomes (15)

  • Maternal sleep quantity

    Through three months following intervention

  • Ability to fall asleep

    Through three months following intervention

  • Sleep quality

    Through three months following intervention

  • Postpartum Sleep Quality

    Through three months following intervention

  • Maternal mental health - Depression

    Through three months following intervention

  • +10 more secondary outcomes

Study Arms (1)

Night Respite Care

EXPERIMENTAL

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

Behavioral: Night Respite Care

Interventions

Night Respite CareBEHAVIORAL

(see description above)

Night Respite Care

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale-identifying individuals living in residential treatment programs
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Entre Familia Residential Treatment Program

Mattapan, Massachusetts, 02126, United States

Location

New Day Residential Treatment Program

Somerville, Massachusetts, 02143, United States

Location

MeSH Terms

Conditions

Opioid-Related DisordersSleep Wake Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Davida M Schiff, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Overnight infant respite care provided approximately 3 nights per week for 6 weeks (18 nights total) lasting eight hours per night. Overnight respite care will last for eight hours, with one hour reserved to provide teaching about infant-specific temperament and cues.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

February 15, 2023

First Posted

February 27, 2023

Study Start

December 20, 2022

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)