SleepNCT06737055
The Dream Team: Testing Implementation of a Sleep Intervention for Perinatal Women Delivered by Direct Care Workers
A study testing Education about behavioral strategies to improve sleep in people with Sleep and Postpartum Depression, run by Rhode Island Hospital at 1 site in United States.
Trial summary
Insufficient and disrupted sleep are rarely addressed in expectant and new mothers, despite evidence that disturbed sleep is a modifiable risk factor for negative health outcomes for mothers and their children. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Postpartum Depression, Pregnancy Related
- What is being tested?
- Education about behavioral strategies to improve sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Phase 1 Inclusion Criteria:
To qualify for Phase 1 enrollment, participants must be:
- over 18 years of age;
- working with expectant and new mothers in a community setting (i.e., outpatient clinic, social service agency, home visiting program, community center);
- in a role where they would be expected to meet with the same client on at least 4 occasions during the perinatal period; in situations where a team-based approach is used to provide services and a client may not see the exact same person at each visit, team members will qualify if they all enroll in the study (e.g., two nurse midwives who provide coverage for each other may both enroll);
- have access to a smart phone to view the training videos, complete the assessments, and access the free CBTi Coach app; speak and read English or Spanish;
- express interest in providing their clients with additional tools to manage sleep disturbances in pregnancy and the postpartum period.
Phase 1 Exclusion Criteria:
The investigators will exclude potential participants who:
- already have certification or a specialty in perinatal sleep (e.g., therapists with formal training in CBTi, individuals with sleep coaching practices);
- those who do not have longitudinal relationships with clients (e.g., intake workers).
Phase 2 Inclusion Criteria:
To qualify, Phase 2 participants must be:
- expectant parents OR new parents up to 1 year postpartum;
- age 18 to 45 years old;
- receiving community-based health, well-being, and or mental health services or treatment from individuals who participated in Phase 1;
- speak and read English or Spanish;
- have access to a smart phone to view the training videos and complete the assessments;
- have clinically significant sleep difficulties defined as an Insomnia Severity Index score greater than 7.
Phase 2 Exclusion Criteria:
The investigators will exclude potential participants whose infants will not be living in the home or who will have a nighttime caregiver.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Katherine M Sharkey, MD, PhD, 401-793-3497, katherine_sharkey@brown.edu
About this study
Insufficient and disrupted sleep are rarely addressed in expectant and new mothers, despite evidence that disturbed sleep is a modifiable risk factor for negative health outcomes for mothers and their children. In this study the investigators will adapt, refine, and pilot test the implementation of a behavioral sleep intervention consisting of short videos designed to accompany a free behavioral sleep app. In Phase 1, the investigators will develop and refine the intervention with input from direct care workers who serve at-risk perinatal women. In Phase 2, direct care workers will deploy the training to expectant mothers with sleep concerns and the investigators will assess the reach, effectiveness, adoption, implementation, and maintenance of this scalable, efficient intervention to improve sleep.
Read the detailed description
Disrupted, insufficient sleep occurs in the majority of pregnant women and increases the risk of negative health consequences for mothers and their infants, including pregnancy and childbirth complications as well as chronic illnesses, such as major depression and weight retention/obesity. Conventionally, perinatal sleep disturbances have been viewed as expected and intractable, but recent studies demonstrate that behavioral interventions are effective for improving sleep in pregnant and postpartum women. Nevertheless, efficient, scalable sleep interventions that are tailored to expectant and new mothers are scarce. This Administrative Supplement for Research on Women's Health seeks to develop a high-fidelity, evidence-based sleep intervention in collaboration with direct care workers who engage with perinatal women and to collect preliminary data regarding delivery of the resulting intervention to expectant and new parents. This pilot project is grounded in the RE-AIM framework, and will assess the Reach, Effectiveness, Adoption, Implementation, and Maintenance dimensions of this model to prepare for a large-scale future R01 hybrid effectiveness-implementation trial. In Phase 1, the investigators will develop short, evidence-based, educational videos in English (with Spanish subtitles) that focus on improving perinatal sleep and that map onto modules in the free, publicly-available mobile app, CBTi Coach. Videos will be produced and refined in cooperation with direct care workers and a video production company with community engagement experience. Direct care workers who work with perinatal women will be trained to deliver the intervention (target n=35). In Phase 2, direct care workers will be invited to use the intervention with clients who report sleep problems and the investigators will study implementation in workers and clients (target n=20).
- Conditions
- Sleep, Postpartum Depression, Pregnancy Related, Insomnia, Sleep Deprivation, Sleep Hygiene
- Being tested
- Education about behavioral strategies to improve sleep
- Keywords
- Home visitors, sleep diaries, education, implementation, RE-AIM
- Medical subject headings
- Depression, Postpartum, Sleep Initiation and Maintenance Disorders, Sleep Deprivation, Sleep Hygiene, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education about behavioral strategies to improve sleepBehavioural
Also called Dream Team Training
In collaboration with direct care workers, the investigators are developing an intervention to help home visitors support clients who experience sleep difficulties in the perinatal period. The intervention consists of a series of educational videos about promoting healthy sleep and addressing sleep difficulties during pregnancy and the postpartum period.
| Study group | Role | What they receive |
|---|---|---|
| Home Visitors | Experimental | The participants in Phase 1 of the proposed study are individuals who provide services to perinatal women who are at risk of postpartum depression. The investigators will recruit 35 adults ages 18 years or older who provide health, well-being, and/or mental health services/treatment to pregnant and postpartum women to participate in Phase 1 of this study. Job titles that meet inclusion criteria include nurses, nurse practitioners, family support workers, therapists, counselors, doulas, lactation consultants, childbirth educators, social workers, public health workers, midwives, and nurse midwives. The investigators will not select participants based on age, gender, sex, or racial or ethnic identity. Receives: Behavioral: Education about behavioral strategies to improve sleep |
| Expectant and New Parents | Experimental | Phase 2 participants will be given access to the educational materials about sleep and the investigators will collect information about their sleep.
To qualify for enrollment, Phase 2 participants must be:
* expectant parents OR new parents up to 1 year postpartum
* 18 to 45 years old
* receiving community-based health, well-being, and or mental health services or treatment from individuals who participated in Phase 1
* speak and read English or Spanish
* have access to a smart phone to view the training videos and complete the sleep diaries and assessments
* are experiencing clinically significant sleep difficulties defined as an Insomnia Severity Index score greater than 7 The investigators will exclude potential participants who are parents whose infants will not be living in the home or who will have a nighttime caregiver Receives: Behavioral: Education about behavioral strategies to improve sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 Reach
Reach: Number of eligible workers who enroll in the training and number of workers who complete the training
Measured: Throughout training period, i.e., for about 6 months; one time measure.
Phase 1 Effectiveness
Effectiveness: Participants are tested before and after training on sleep and circadian rhythm knowledge. Questions are based on the learning objectives for the educational modules. A successful outcome will be defined as >= 70% of sleep knowledge questions answered correctly.
Measured: At enrollment and 1 month after training.
Phase 1 Acceptability
Acceptability: Participants will complete an online questionnaire to assess their perceptions of the training videos including Likert scales where they will report on (a) how prepared they feel to deliver the intervention; (b) ease of use; (c) compatibility with other resources they provide; and (d) the likelihood that they will use the app with their clients. This questionnaire will also include a short answer section for participants to report facilitators and barriers to use of the intervention.
Measured: 1 month after training
Phase 2 Reach
Reach: Investigators will track what percent of clients who are referred actually enroll, the number of pregnant vs. postpartum women who enroll, and the number of fathers/partners who enroll.
Measured: one time measure during enrollment period, ~ 6 months
Phase 2 Effectiveness
Effectiveness: Clients will complete a brief survey to assess their perceptions of the acceptability and utility of the intervention.
Measured: 6 weeks after enrollment
Phase 2 Effectiveness - Insomnia Severity Index
Participants will complete the 7-item Insomnia Severity Index (ISI, range 0-28, higher scores indicate more sleep disturbance) at enrollment and 6 weeks after enrollment.
Measured: at enrollment and 6 weeks after enrollment
Phase 2 Effectiveness - Implementation
Implementation: After clients enroll, investigators will assess quantitative implementation measures related to whether clients engage with the intervention as intended through metadata provided by the app and website (i.e., time spent on the app in minutes and time spent viewing videos in minutes).
Measured: from enrolllment through 6 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start8 Aug 2023
- Primary completion31 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is an implementation science project to develop and test an educational program for teaching home visitors and expectant and new parents about sleep. The study uses the RE-AIM framework.
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bradley Hospital
- Responsible party
- Sponsor
- Investigators
- Katherine M Sharkey, MD, PhD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737055
- Sponsor's protocol ID
- 1848819
- Status last verified
- Dec 2024
- First submitted
- 1 Jul 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final computerized research datasets will include both raw and summary data as well as documentation so that others can make use of the data. These data represent a valuable public resource and the investigators strongly support the notion that other researchers will be able to capitalize on the efforts and funding that go into collecting and processing these data.
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dream Team: Testing Implementation of a Sleep Intervention for Perinatal Women Delivered by Direct Care Workers
- ClinicalTrials.gov ID
- NCT06737055
- Acronym / sponsor ID
- 1848819
- Conditions
- Sleep, Postpartum Depression, Pregnancy Related, Insomnia, Sleep Deprivation, Sleep Hygiene
- Keywords
- Home visitors, sleep diaries, education, implementation, RE-AIM
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- Bradley Hospital
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Insufficient and disrupted sleep are rarely addressed in expectant and new mothers, despite evidence that disturbed sleep is a modifiable risk factor for negative health outcomes for mothers and their children. In this study the investigators will adapt, refine, and pilot test the implementation of a behavioral sleep intervention consisting of short videos designed to accompany a free behavioral sleep app. In Phase 1, the investigators will develop and refine the intervention with input from direct care workers who serve at-risk perinatal women. In Phase 2, direct care workers will deploy the training to expectant mothers with sleep concerns and the investigators will assess the reach, effectiveness, adoption, implementation, and maintenance of this scalable, efficient intervention to improve sleep.
Detailed description
Disrupted, insufficient sleep occurs in the majority of pregnant women and increases the risk of negative health consequences for mothers and their infants, including pregnancy and childbirth complications as well as chronic illnesses, such as major depression and weight retention/obesity. Conventionally, perinatal sleep disturbances have been viewed as expected and intractable, but recent studies demonstrate that behavioral interventions are effective for improving sleep in pregnant and postpartum women. Nevertheless, efficient, scalable sleep interventions that are tailored to expectant and new mothers are scarce. This Administrative Supplement for Research on Women's Health seeks to develop a high-fidelity, evidence-based sleep intervention in collaboration with direct care workers who engage with perinatal women and to collect preliminary data regarding delivery of the resulting intervention to expectant and new parents. This pilot project is grounded in the RE-AIM framework, and will assess the Reach, Effectiveness, Adoption, Implementation, and Maintenance dimensions of this model to prepare for a large-scale future R01 hybrid effectiveness-implementation trial. In Phase 1, the investigators will develop short, evidence-based, educational videos in English (with Spanish subtitles) that focus on improving perinatal sleep and that map onto modules in the free, publicly-available mobile app, CBTi Coach. Videos will be produced and refined in cooperation with direct care workers and a video production company with community engagement experience. Direct care workers who work with perinatal women will be trained to deliver the intervention (target n=35). In Phase 2, direct care workers will be invited to use the intervention with clients who report sleep problems and the investigators will study implementation in workers and clients (target n=20).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an implementation science project to develop and test an educational program for teaching home visitors and expectant and new parents about sleep. The study uses the RE-AIM framework.
| Arm | Type | Receives |
|---|---|---|
| Home Visitors | Experimental | Behavioral: Education about behavioral strategies to improve sleepThe participants in Phase 1 of the proposed study are individuals who provide services to perinatal women who are at risk of postpartum depression. The investigators will recruit 35 adults ages 18 years or older who provide health, well-being, and/or mental health services/treatment to pregnant and postpartum women to participate in Phase 1 of this study. Job titles that meet inclusion criteria include nurses, nurse practitioners, family support workers, therapists, counselors, doulas, lactation consultants, childbirth educators, social workers, public health workers, midwives, and nurse midwives. The investigators will not select participants based on age, gender, sex, or racial or ethnic identity. |
| Expectant and New Parents | Experimental | Behavioral: Education about behavioral strategies to improve sleepPhase 2 participants will be given access to the educational materials about sleep and the investigators will collect information about their sleep. To qualify for enrollment, Phase 2 participants must be: * expectant parents OR new parents up to 1 year postpartum * 18 to 45 years old * receiving community-based health, well-being, and or mental health services or treatment from individuals who participated in Phase 1 * speak and read English or Spanish * have access to a smart phone to view the training videos and complete the sleep diaries and assessments * are experiencing clinically significant sleep difficulties defined as an Insomnia Severity Index score greater than 7 The investigators will exclude potential participants who are parents whose infants will not be living in the home or who will have a nighttime caregiver |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education about behavioral strategies to improve sleepAlso: Dream Team TrainingIn collaboration with direct care workers, the investigators are developing an intervention to help home visitors support clients who experience sleep difficulties in the perinatal period. The intervention consists of a series of educational videos about promoting healthy sleep and addressing sleep difficulties during pregnancy and the postpartum period. | Behavioural | Expectant and New Parents, Home Visitors |
Primary outcome
Phase 1 Reach
Time frame: Throughout training period, i.e., for about 6 months; one time measure.
Reach: Number of eligible workers who enroll in the training and number of workers who complete the training
Phase 1 Effectiveness
Time frame: At enrollment and 1 month after training.
Effectiveness: Participants are tested before and after training on sleep and circadian rhythm knowledge. Questions are based on the learning objectives for the educational modules. A successful outcome will be defined as >= 70% of sleep knowledge questions answered correctly.
Phase 1 Acceptability
Time frame: 1 month after training
Acceptability: Participants will complete an online questionnaire to assess their perceptions of the training videos including Likert scales where they will report on (a) how prepared they feel to deliver the intervention; (b) ease of use; (c) compatibility with other resources they provide; and (d) the likelihood that they will use the app with their clients. This questionnaire will also include a short answer section for participants to report facilitators and barriers to use of the intervention.
Phase 2 Reach
Time frame: one time measure during enrollment period, ~ 6 months
Reach: Investigators will track what percent of clients who are referred actually enroll, the number of pregnant vs. postpartum women who enroll, and the number of fathers/partners who enroll.
Phase 2 Effectiveness
Time frame: 6 weeks after enrollment
Effectiveness: Clients will complete a brief survey to assess their perceptions of the acceptability and utility of the intervention.
Phase 2 Effectiveness - Insomnia Severity Index
Time frame: at enrollment and 6 weeks after enrollment
Participants will complete the 7-item Insomnia Severity Index (ISI, range 0-28, higher scores indicate more sleep disturbance) at enrollment and 6 weeks after enrollment.
Phase 2 Effectiveness - Implementation
Time frame: from enrolllment through 6 weeks after enrollment
Implementation: After clients enroll, investigators will assess quantitative implementation measures related to whether clients engage with the intervention as intended through metadata provided by the app and website (i.e., time spent on the app in minutes and time spent viewing videos in minutes).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: Yes. The final computerized research datasets will include both raw and summary data as well as documentation so that others can make use of the data. These data represent a valuable public resource and the investigators strongly support the notion that other researchers will be able to capitalize on the efforts and funding that go into collecting and processing these data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine M Sharkey, MD, PhD principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education about behavioral strategies to improve sleep in people with Sleep and Postpartum Depression, run by Rhode Island Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine M Sharkey, MD, PhD (401-793-3497, katherine_sharkey@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 Reach (time frame: Throughout training period, i.e., for about 6 months; one time measure.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.