Helping Young Children Sleep

July 19, 2017 updated by: Mark Splaingard, Nationwide Children's Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 3 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No treatment
Experimental: Internet
Internet site that offers parents tips on promoting sleep in infants and toddlers
Behavioral: Internet
Experimental: DVD
DVD that offers parents tips on promoting sleep in infants and toddlers
Behavioral: DVD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief infant sleep questionnaire
Time Frame: 3 weeks
infant sleep patterns and sleep problems
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Profile of mood states
Time Frame: 1 week
parental mood in the past week
1 week
Pittsburgh sleep quality index
Time Frame: 1 month
parental sleep patterns within the past month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nationwide Children's Hospital

Investigators

  • Principal Investigator: Mark Splaingard, MD, Nationwide Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

November 15, 2012

First Submitted That Met QC Criteria

November 19, 2012

First Posted (Estimate)

November 20, 2012

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 19, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB12-00439

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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