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OpenTrials
Completed

NCT Number: NCT01729715

Helping Young Children Sleep

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

6 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet

Behavioral

DVD

Behavioral

Primary outcomes

  1. Brief infant sleep questionnaire

    Time frame: 3 weeks

    infant sleep patterns and sleep problems

Secondary outcomes

  1. Profile of mood states

    Time frame: 1 week

    parental mood in the past week

  2. Pittsburgh sleep quality index

    Time frame: 1 month

    parental sleep patterns within the past month

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2017
First posted
Nov 20, 2012
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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