Maternal Drugs Affecting Fetus, Neonatal Opioid Withdrawal, Opioid Use Disorder, Postpartum Mood Disturbance, Sleep Disorder
Conditions
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.
Detailed description
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.
Interventions
BEHAVIORALNight Respite Care
(see description above)
Sponsors
Massachusetts General Hospital
National Institute on Drug Abuse (NIDA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | Period from signing study consent form to completing screening and baseline, ranged from 1d to several weeks, on average less than a week | Number of individuals who study consent AND completed screening and baseline, this being eligible to start intervention |
| Participation in Intervention | Completion of consent and screening/baseline through end of intervention period, approximately 6 weeks | Reciept of any nights of respite care during the intervention period |
| Study Feasibility | At completion of the intervention, up to six weeks following the completion | Count of total number individuals completing intervention and retained through study follow up |
| Study Acceptability | At completion of the intervention, up to six weeks after last night of respite. | Feedback in semi-structured interviews with participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Sleep Quantity | Measurement began between 1 week and 1 day before starting respite and continued until at least one day after respite care ended, maximum of 8 weeks | Measurement of total sleep using actigraphy device in a 24hr period |
| Ability to Fall Asleep | Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention) | Insomnia Sleep Index (Measured on a scale of 0-28). Insomnia symptoms were assessed using a brief insomnia symptom score capturing difficulty initiating sleep, maintaining sleep, and sleep satisfaction. Higher scores indicate greater insomnia severity. This measure was analyzed as a single continuous outcome reflecting insomnia symptom burden. |
| Sleep Quality | Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention) | Single Item Sleep Quality Scale; Overall perceived sleep quality was assessed using a single-item self-report measure asking participants to rate their global sleep quality over a recent time period. Higher scores reflect better perceived sleep quality. Single-item sleep quality measures have demonstrated sensitivity to change and strong correlations with multi-item sleep scales in postpartum populations. Participants rate their overall sleep quality using a single-item self-report measure. Scores range from 0 to 10, where 0 = terrible sleep quality and 10 = excellent sleep quality. Higher scores indicate better perceived sleep quality. |
| Postpartum Sleep Quality | Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention) | Postpartum-specific sleep quality was measured using the Postpartum Sleep Quality Scale is a caregiver-reported measure of postpartum sleep quality. The PSQS includes the following subscales: Infant-Related Sleep Disruption subscale: range 0-42 Physical Symptoms subscale: range 0-42 Total PSQS score: range 0-84, calculated by summing item responses across subscales. For all PSQS scores, higher values indicate worse postpartum sleep quality and greater sleep burden. |
| Maternal Mental Health - Depression | Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention) | Patient Health Questionnaire-8: Depressive symptoms were measured using the PHQ-8, an 8-item self-report scale assessing core symptoms of depression over the past two weeks. Items are scored from 0 ("not at all") to 3 ("nearly every day"), with total scores ranging from 0 to 24. The PHQ-8 is a unidimensional measure and is widely used in postpartum and population-based studies. A higher score indicates greater degree of depressive symptoms |
| Maternal Mental Health - Anxiety | Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention) | Anxiety symptoms were assessed using the GAD-7, a validated 7-item self-report measure of generalized anxiety symptoms over the past two weeks. Items are scored on a 0-3 Likert scale, yielding a total score ranging from 0 to 21, with higher scores indicating greater anxiety severity. The GAD-7 is unidimensional and has demonstrated strong reliability and validity in perinatal populations. |
| Recovery Capitol | Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention) | The BARC-10 is a 10-item self-report measure assessing personal, social, and community resources that support recovery from substance use disorder. Each item is scored from 1 to 6 and summed to create a total score. Total score range: 10-60 Higher scores indicate greater recovery capital and a better recovery-related outcome. The scale is analyzed as a single total score. |
| Parental Stress | Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention) | Parenting Stress Index-Short Form (PSI-SF). The PSI-SF is a 36-item caregiver-reported measure that yields three subscale scores and a Total Stress Score: Parental Distress (PD): range 12-60 Parent-Child Dysfunctional Interaction (P-CDI): range 12-60 Difficult Child (DC): range 12-60 Total Stress Score: range 36-180, calculated as the sum of the three subscales Higher scores indicate greater parenting stress and a worse outcome. |
| Parental Bonding | Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention) | Postpartum Bonding Questionnaire (PBQ); The PBQ is a 25-item caregiver-reported measure assessing disturbances in the parent-infant relationship. It includes the following subscales: Impaired Bonding: range 0-60 Rejection and Anger: range 0-36 Infant-Focused Anxiety: range 0-20 Risk of Abuse: range 0-12 Total PBQ score: range 0-100, calculated by summing all items Higher scores indicate greater bonding difficulties and a worse outcome. |
| Parental Self-efficacy | Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention) | Parenting self-efficacy was measured using the Perceived Maternal Parenting Self-Efficacy Scale, a multi-item self-report instrument assessing caregivers' confidence in their parenting skills and ability to manage parenting tasks. The Perceived Maternal Parenting Self-Efficacy Scale is a 20-item self-report measure assessing caregivers' confidence in their parenting abilities and performance of parenting tasks. Total score range: 20-80 (20 items scored 1-4 and summed) Higher scores indicate greater parenting self-efficacy and a better outcome. The scale is analyzed as a total score. |
| Social Support | Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention) | Perceived social support in the postpartum period was assessed using the Postpartum Social Support Screening tool, a caregiver-reported measure evaluating emotional, instrumental, and informational support. The scale includes multiple items and is commonly analyzed as a total score reflecting overall perceived support. There are 9 total questions that range from 1 (none of the time) to 5 (all of the time) and the total score is summed. The scores can range from 9-45 and and high score indicate higher postpartum social support. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavida M Schiff, MD
Massachusetts General Hospital
Participant flow
Recruitment details
There were 41 pregnant or postpartum individuals interested who consented to participate in the study
Pre-assignment details
Of 41 individuals who consented to be part of the study, 32 completed all of the screening and baseline questionnaires and were subsequently eligible to received respite care in the trial.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants |
| Age, Continuous | 33.05 years STANDARD_DEVIATION 4.77 |
| Current children in your custody | 1.2 Number of Children STANDARD_DEVIATION 0.6 |
| Current DCF involvement | 28 Participants |
| Employment Status Employed for wages, self-employed | 2 Participants |
| Employment Status Homemaker/Parental Leave | 6 Participants |
| Employment Status Out of work | 15 Participants |
| Employment Status Student | 1 Participants |
| Employment Status Unable to work | 13 Participants |
| Health Insurance Status Health Insurance obtained | 36 Participants |
| Health Insurance Status No health insurance | 1 Participants |
| Highest level of education attained College Degree | 2 Participants |
| Highest level of education attained Did not obtain high school degree | 9 Participants |
| Highest level of education attained High School Degree | 15 Participants |
| Highest level of education attained Some college | 11 Participants |
| Housing Status In room/home I own/rent | 2 Participants |
| Housing Status Residential treatment program | 33 Participants |
| Housing Status Shelter, Family + Friends | 2 Participants |
| Incarceration history No | 17 Participants |
| Incarceration history Yes | 20 Participants |
| Infant age at start of respite 3-6 months | 4 Participants |
| Infant age at start of respite Less than 3 months old | 30 Participants |
| Infant age at start of respite Not avaialble (infant not born @ study completion) | 1 Participants |
| Infant age at start of respite Older than 6 months | 2 Participants |
| Infant feeding type Formula Only | 24 Participants |
| Infant feeding type Mixed Breast and Formula | 13 Participants |
| Medical History Breathing or Throat Problems | 6 Participants |
| Medical History Dental Problems | 9 Participants |
| Medical History Endocrine or Metabolic Problems | 2 Participants |
| Medical History Eye Problems | 8 Participants |
| Medical History Heart Problems | 4 Participants |
| Medical History Liver or GI problems | 9 Participants |
| Medical History Neurologic Problems | 2 Participants |
| Medical History Skin Problems | 2 Participants |
| Mental Health Diagnoses Anxiety | 27 Participants |
| Mental Health Diagnoses Bipolar Disorder | 16 Participants |
| Mental Health Diagnoses Depression | 24 Participants |
| Mental Health Diagnoses No psychiatric diagoses | 7 Participants |
| Mental Health Diagnoses Post-Traumatic Stress Disorder | 20 Participants |
| Past Substance Use Cannabis | 22 Participants |
| Past Substance Use Cocaine/Crack | 25 Participants |
| Past Substance Use Hallucinogens | 9 Participants |
| Past Substance Use Heroin or fentanyl | 24 Participants |
| Past Substance Use Stimulants (Amphetamine/Methamphetamine) | 15 Participants |
| Past Substance Use Tranquilizers or anti-anxiety drugs | 15 Participants |
| Pregnancy History - Gravida | 3.9 Number of Pregnancies STANDARD_DEVIATION 2.2 |
| Pregnancy History - Parity | 2.5 Number of Deliveries STANDARD_DEVIATION 1.3 |
| Psychiatric hospitalization | 14 Participants |
| Race/Ethnicity, Customized Hispanic | 7 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 2 Participants |
| Race/Ethnicity, Customized Non-Hispanic Mixed Race | 4 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 24 Participants |
| Relationship Status Dating | 5 Participants |
| Relationship Status Living with a partner | 1 Participants |
| Relationship Status Married/Partnered | 9 Participants |
| Relationship Status Other | 3 Participants |
| Relationship Status Single | 19 Participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 0 Participants |
| Substance use treatment receipt Acute Withdrawal Services (Detoxification) | 25 Participants |
| Substance use treatment receipt Counseling | 20 Participants |
| Substance use treatment receipt Family residential treatment (parenting/with child | 13 Participants |
| Substance use treatment receipt Intensive Outpatient Treatment | 13 Participants |
| Substance use treatment receipt Involuntary Civil Commitment | 14 Participants |
| Substance use treatment receipt Mutual Help Meetings | 21 Participants |
| Substance use treatment receipt Residential treatment | 23 Participants |
| Use of any past buprenorphine, methadone, or naltrexone? | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 41 |
| other Total, other adverse events | 0 / 41 |
| serious Total, serious adverse events | 0 / 41 |
Outcome results
None listed