Parent Intervention to Improve Child Sleep

University of South Carolina

Status: Completed

Conditions: Sleep

Treatments: Behavioral: Sleep Tight

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06038591

5P20GM130420 (U.S. NIH Grant/Contract)

Pro00123879

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 2 to 4 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Sleep Intervention

Experimental group

Description:

The 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.

Treatment:

Behavioral: Sleep Tight

Comparison/control

No Intervention group

Description:

The comparison arm is a no-contact control group. Parents and children will not receive any intervention. They will be placed on a wait-list, and then offered the sleep intervention once the post-assessments are complete.