A Sleep Hygiene-based Intervention Program for Infants and Toddlers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

247 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Sleep problems during infancy are associated with behavior and emotional problems, poor language development , parental distress and mood disturbances, and overweight and obese children. The investigators proposed that children who receive the light, activity, and sleep training (LAST) intervention program in this study will have less parent report of problem sleep behaviors and longer duration of nighttime sleep compared to children with no intervention provided.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bedtime Routines and Children's Health

NCT05201924

Myopia Dental Caries Sleep +1 more

COMPLETED NA

Behavioral Effects of Obstructive Sleep Apnea in Children

NCT00060723

Sleep-disordered Breathing Sleep Apnea, Obstructive ADHD

COMPLETED

The Effect of Sleep Hygiene Training Implemented

NCT05957874

Sleep Hygiene

COMPLETED NA

Brain Tissue Integrity and Autonomic Function Alterations in Childhood OSA and ADHD, and After Adenotonsillectomy.

NCT04732572

Attention-deficit/Hyperactivity Disorder Autonomic Nervous System Imbalance Obstructive Sleep Apnea of Child

UNKNOWN NA

Parent Intervention to Improve Child Sleep

NCT06038591

Sleep

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Sleep problems are reported in 71.65% of our nation's infants and toddlers, and the prevalence is much higher than the 20-30% reported in Western countries. The investigators' preliminary findings also show that approximately 53-55% of parents of children between 6 and 12 months of age consider their child sleep a problem with about 4% not knowing whether their child sleep is a problem. Sleep development during infancy is characterized by increasing day-night differences in sleep-wakefulness such as longer bouts of sleep and fewer awakenings at night, and is driven by neurobiological maturation and environmental interactions. By 3 months of age, nearly 58% of infants can sleep continuously between 24:00-05:00 hours. When infants do not sleep through the night by 17 months of age, they are less likely to be able to do so at 29 months of age and beyond. Without proper intervention, sleep problems during infancy can persist to toddler and preschool age. Various interventions have been developed and tested in Western and Asian Countries to address the sleep problems in infants and young children, but none are in Taiwan.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sleep hygiene & standard care

Participants receive a light, activity, and sleep training (LAST) intervention consists of behavioral and educational strategies for increasing light exposure and physical activity to minimize sleep disturbance.

Group Type EXPERIMENTAL

Sleep hygiene

Intervention Type BEHAVIORAL

LAST intervention (light, activity, and sleep training) consists of behavioral and educational strategies for increasing light exposure and physical activity, minimizing television viewing and reducing television viewing time to \< 2 hours per day, and engaging activities suitable to the child's motor development to minimize sleep disturbance.

Standard care

Participants receive usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sleep hygiene

LAST intervention (light, activity, and sleep training) consists of behavioral and educational strategies for increasing light exposure and physical activity, minimizing television viewing and reducing television viewing time to \< 2 hours per day, and engaging activities suitable to the child's motor development to minimize sleep disturbance.

Intervention Type BEHAVIORAL