Pediatric Sleep Clinical Trial
Official title:
Community Partnership for Healthy Sleep
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05130229 -
Community Partnership for Healthy Sleep: Sleep Well, Bee Well Part 2
|
N/A |