Clinical Trials Directory

Trials / Completed

CompletedNCT06038591

Parent Intervention to Improve Child Sleep

Parenting Intervention to Improve Young Children's Sleep Among Families With Low Income

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
University of South Carolina · Academic / Other
Sex
All
Age
2 Years – 4 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSleep TightThe sleep intervention focuses on enhancing young children's sleep by providing parents with behavioral strategies and support. Interventionists will work with parents on establishing consistent soothing bedtime routines; behavioral regulation to manage bedtime resistance and nighttime wakings; goal setting, problem solving, and action planning; self-monitoring via daily sleep logs; and stimulus control of child's sleep environment.

Timeline

Start date
2024-01-08
Primary completion
2025-01-03
Completion
2025-03-28
First posted
2023-09-15
Last updated
2025-04-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06038591. Inclusion in this directory is not an endorsement.