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Helping Young Children Sleep

Primary Purpose

Insomnia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet
DVD
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Pediatric, Insomnia

Eligibility Criteria

6 Months - 36 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Internet

DVD

No treatment

Arm Description

Internet site that offers parents tips on promoting sleep in infants and toddlers

DVD that offers parents tips on promoting sleep in infants and toddlers

Outcomes

Primary Outcome Measures

Brief infant sleep questionnaire
infant sleep patterns and sleep problems

Secondary Outcome Measures

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

Full Information

First Posted
November 15, 2012
Last Updated
July 19, 2017
Sponsor
Nationwide Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01729715
Brief Title
Helping Young Children Sleep
Official Title
Helping Young Children Sleep
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Pediatric, Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet
Arm Type
Experimental
Arm Description
Internet site that offers parents tips on promoting sleep in infants and toddlers
Arm Title
DVD
Arm Type
Experimental
Arm Description
DVD that offers parents tips on promoting sleep in infants and toddlers
Arm Title
No treatment
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Internet
Intervention Type
Behavioral
Intervention Name(s)
DVD
Primary Outcome Measure Information:
Title
Brief infant sleep questionnaire
Description
infant sleep patterns and sleep problems
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Profile of mood states
Description
parental mood in the past week
Time Frame
1 week
Title
Pittsburgh sleep quality index
Description
parental sleep patterns within the past month
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Splaingard, MD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States

12. IPD Sharing Statement

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Helping Young Children Sleep

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