Helping Young Children Sleep

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Behavioral: Internet; Behavioral: DVD

• Registration Number: NCT01729715
• Lead Sponsor: Nationwide Children's Hospital

Brief Summary

The investigators are conducting a randomized trial of behavioral treatments for young children with insomnia. The investigators are comparing the improvement in sleep patterns after families are given access to Internet sleep instructions compared to DVD sleep instructions.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-15
• Study First Submitted QC: 2012-11-19
• Study First Posted: 2012-11-20
• Primary Completion: 2015-11
• Study Completion: 2017-03
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-19
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• 6-36 months
• difficulties falling asleep or staying asleep
• DVD and internet access

Exclusion Criteria

• Under 14 pounds
• Requires nighttime feeding or parental intervention for health reasons
• Chronic medical or psychological conditions such as asthma or autism
• Parents prefer co-sleeping

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internet	Internet	Internet site that offers parents tips on promoting sleep in infants and toddlers
DVD	DVD	DVD that offers parents tips on promoting sleep in infants and toddlers

Primary Outcome Measures

Name	Time	Method
Brief infant sleep questionnaire	3 weeks	infant sleep patterns and sleep problems

Secondary Outcome Measures

Name	Time	Method
Profile of mood states	1 week	parental mood in the past week
Pittsburgh sleep quality index	1 month	parental sleep patterns within the past month

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States