Clinical trial NCT03045874: Community Partnership for Healthy Sleep
Official title: Community Partnership for Healthy Sleep
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Sleep
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2017-02-08
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents will reside in New Haven and obtain pediatric health care in a New Haven community practice.

Pediatric primary care providers will be experienced in the care of community children and will include physicians, senior resident pediatricians, and nurse practitioners (NPs) who provide primary care in the greater New Haven area and speak English.

Brief summary: The purpose of this study is to conduct community-engaged research (CEnR) with families and pediatric providers caring for the children in those families to address the following specific aims:

1. Examine parents' knowledge and perceptions about their 6-36 month old children's sleep and objective characteristics of sleep, including (1a) self-reported and actigraph-recorded characteristics of sleep, sleep habits, and difficulty; (1b) the contributions of sleep habits and individual, family, community, cultural/social, and health-related factors to sleep characteristics and sleep difficulty; (1c) consequences of sleep difficulty; (1d) successful and unsuccessful strategies used to promote children's sleep and sleep habits; (1e) preferences regarding sleep promotion interventions for their children; and perceptions of the optimal timing to begin sleep promotion intervention
2. Examine pediatric primary care providers' perceptions about (2a) the importance of sleep and sleep habits for 6-36 month old children; (2b) factors that contribute to sleep habits and sleep difficulty; (2c) successful and unsuccessful approaches to promote healthy sleep habits, adequate duration and good quality sleep and assessment and management of sleep difficulty in young children within the context of their families; and (2c) barriers, facilitators, and preferences regarding sleep-promoting interventions for families with young children;
3. Collaborate with families and providers to use the information obtained in Aims 1 and 2 to develop and refine a feasible, relevant, and acceptable sleep promotion program, including procedures, protocols, patient materials, intervention fidelity plans, and delivery methods.

Detailed description: The investigators will conduct this study in 3 phases, employ Community Engaged Research (CEnR), and use guidelines for community participation developed through Yale Center for Clinical Investigation (YCCI/Yale's CTSA). The Social Ecological Model, depicting interactions among the environment, individual, family, community, and society as they influence health, will guide the study. The key informants and community and clinical stakeholders represent layers of the model49-51 acknowledging the critical intersection between the model components and health promotion behavior (i.e., healthy sleep habits).

Community Engagement. The investigators will extend the CEnR process begun in our preliminary work to engage two groups of community stakeholders: parents of children between the ages of 6-36 months and pediatric primary care clinicians who provide health care to those children. The investigators will invite 8-10 volunteers (pediatricians, nurse practitioners, parents of 6-18 month old children, parents of 19-36 month olds) to join our team as members of a Community Advisory Committee that will meet quarterly throughout this project to assist with oversight and share decision-making about methods, interpretation of findings, and intervention development, implementation, evaluation, and dissemination. The investigators will meet at convenient times and locations and use conference calls if preferred. The investigators will compensate parents and providers for time spent in study activities and reimburse parents for taxi cab fare. The investigators will provide onsite childcare in a separate room from the interviews. The investigators will offer committee members co-authorship on reports and collaboration on disseminating information on sleep habits into the community. The investigators will also invite them to continue to guide future studies and intervention projects. Consistent with a CEnR approach, The investigators will include them as full partners in future collaborations as preferred.

In Phase I/Aims 1 \& 2 the investigators will employ a convergent mixed methods approach in which the investigators will collect quantitative (questionnaires) and qualitative interview data (semi-structured interview) about parents' perceptions of children's sleep, sleep habits, sleep difficulty, and sleep-promoting interventions (Aim 1). The investigators will also use semi-structured interviews to elicit perceptions about the importance of sleep, promotion of healthy sleep habits, sleep assessment, sleep difficulties, and barrier and facilitators to sleep promotion, assessment, and intervention from primary care clinicians (Aim 2).

In Phase II/Aim 3 the investigators will collaborate with the Community Advisory Board to draft a sleep promotion program, based on phase I results and the literature. Deliverables will include objectives, content, procedures, protocols, patient materials, intervention fidelity procedures, and delivery methods, including a possible prototype of an mHealth approach. The investigators will use an iterative method, including focus groups with our two communities, for member checking and cognitive interviewing to assess feasibility, cultural relevance and acceptability of the intervention. Investigators will conduct feasibility testing of the sleep promotion intervention in one childcare center.

Eligibility criteria: Inclusion Criteria for parents:

* fluent in English
* New Haven residents
* obtain pediatric care in a New Haven community practice
* parents of 6-18 month old children
* parents of 19-36 month old children

Exclusion Criteria for parents:

* severe mental illness
* severe cognition impairment
* substance-related symptoms requiring inpatient hospitalization or ambulatory detoxification
* those whose children have a serious illness, significant developmental delays
* parents with children in custody of the CT Department of Children and Family Services

Inclusion Criteria for Pediatric primary care providers

* experienced in the care of community children
* provide care in the greater New Haven are
* speak English

Primary outcomes:
measure: parent knowledge about sleep
timeFrame: interview of approximately 60 minutes
measure: parent distress/stress via Brief Symptom Inventory (BSI)
timeFrame: interview of approximately 60 minutes
measure: actigraph sleep duration
timeFrame: 9 nights
measure: actigraph sleep efficiency
timeFrame: 9 nights
measure: actigraph nap duration
timeFrame: 9 days
measure: parent-reported sleep patterns
timeFrame: interview of approximately 60 minutes
measure: parent stress/distress via Parenting Stress Index (PSI)-Short Form
timeFrame: interview of approximately 60 minutes
Secondary outcomes:
measure: perceptions of the importance of sleep from providers
timeFrame: interview of approximately 60 minutes
measure: successful and unsuccessful approaches to promoting healthy sleep habits from providers
timeFrame: interview of approximately 60 minutes
measure: assessing and managing sleep disorders from providers
timeFrame: interview of approximately 60 minutes
measure: resources needed to support assessment and management from providers
timeFrame: interview of approximately 60 minutes
measure: barriers, facilitators, and preferences for sleep-promoting interventions from providers
timeFrame: interview of approximately 60 minutes
measure: focus group to assess feasibility, cultural relevance and acceptability
timeFrame: 90 minutes
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale School of Nursing
name: Nancy Redeker, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale School of Nursing
name: Lois Sadler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ordway MR, Sadler LS, Jeon S, O'Connell M, Banasiak N, Fenick AM, Crowley AA, Canapari C, Redeker NS. Sleep health in young children living with socioeconomic adversity. Res Nurs Health. 2020 Aug;43(4):329-340. doi: 10.1002/nur.22023. Epub 2020 Apr 19.