Clinical trial NCT06038591: Parent Intervention to Improve Child Sleep
Official title: Parenting Intervention to Improve Young Children's Sleep Among Families With Low Income
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Temple University
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2023-09-15
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study, the investigators pilot tested a parenting intervention to improve young children's sleep in families with low income. Families were randomized to an intervention or wait-list control group. The investigators hypothesized the intervention would be feasible and acceptable to enrolled families.

Detailed description: This pilot study tested a parenting intervention to improve young children's sleep in families with low income using a randomized controlled trial (RCT) design. Parents were randomized to the intervention or wait-list control group. Intervention content was delivered in virtual sessions with a parent and interventionist. The primary aim was to examine intervention feasibility (e.g., recruitment, retention, acceptability) with a secondary goal of preliminary efficacy on intervention changes in child sleep patterns to inform a future large-scale RCT. Exploratory evidence was collected on changes in children's health behaviors (e.g., diet, screen time), and social-emotional health (e.g., behavior problems) as indicators for potential spillover effects on these domains.

Eligibility criteria: Inclusion Criteria:

* Parents or primary caregivers 18 years of age or older
* Have a child 2-4 years of age
* Child's 24-hour sleep duration does not meet established recommendations based on child age
* English speaking
* Annual household income \<= 200% of the Federal Poverty Line or receive assistance benefits (e.g., SNAP, WIC)
* Computer or phone access for video calls

Exclusion Criteria:

* Parent or child has a medical condition that impairs their ability to participate
* Child has a clinical sleep disorder
* Child takes medication that significantly impacts their sleep

Primary outcomes:
measure: Intervention feasibility: recruitment screening eligibility
timeFrame: Through study completion, an average of 2 years
measure: Intervention feasibility: recruitment screening enrollment
timeFrame: Through study completion, an average of 2 years
measure: Intervention feasibility: recruitment duration
timeFrame: Through study completion, an average of 2 years
measure: Intervention feasibility: Enrollment yield for each recruitment strategy
timeFrame: Through study completion, an average of 2 years
measure: Intervention feasibility: retention attendance
timeFrame: Through study completion, an average of 2 years
measure: Intervention feasibility: retention percentage
timeFrame: Through study completion, an average of 2 years
measure: Intervention feasibility: retention dropout
timeFrame: Through study completion, an average of 2 years
measure: Intervention feasibility: retention dropout reasons
timeFrame: Through study completion, an average of 2 years
measure: Intervention acceptability
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Process measures: Intervention attendance
timeFrame: Through study completion, an average of 2 years
measure: Process measures: Content fidelity
timeFrame: Through study completion, an average of 2 years
measure: Process measure: Implementation
timeFrame: Through study completion, an average of 2 years
measure: Child sleep: night sleep duration
timeFrame: Baseline (0 weeks) and post-intervention (6 weeks)
measure: Child sleep: daytime sleep duration
timeFrame: Baseline (0 weeks) and post-intervention (6 weeks)
measure: Child sleep: 24-hour sleep duration
timeFrame: Baseline (0 weeks) and post-intervention (6 weeks)
measure: Child sleep: sleep quality
timeFrame: Baseline (0 weeks) and post-intervention (6 weeks)
measure: Child sleep: sleep timing
timeFrame: Baseline (0 weeks) and post-intervention (6 weeks)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: South Carolina early childhood support state agencies
state: South Carolina
Study officials:
References: