Helping Young Children Sleep | NCT01729715

Studies
Helping Young Children Sleep

NCT01729715

Sponsor

Nationwide Children's Hospital

Status

Completed

Last Update Posted

Jul 21, 2017Actual

Enrollment

240Actual

Phase

Not Applicable

Conditions

Insomnia

Interventions

Internet
DVD

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Nov 2015Actual

Completion Date

Mar 2017Actual

First Submitted Date

Nov 15, 2012

First Submission Date that Met QC Criteria

Nov 19, 2012

First Posted Date

Nov 20, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2017

Last Update Posted Date

Jul 21, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mark Splaingard, Prof. and Dir. of pediatric sleep medicine, Nationwide Children's HospitalPrincipal Investigator

Lead Sponsor

Nationwide Children's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Internet	Experimental	Internet site that offers parents tips on promoting sleep in infants and toddlers	Behavioral: Internet
DVD	Experimental	DVD that offers parents tips on promoting sleep in infants and toddlers	Behavioral: DVD
No treatment	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Internet	Behavioral		Internet
DVD

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

36 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark Splaingard, MD	Nationwide Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nationwide Children's Hospital		Columbus	Ohio	43205	United States

Condition Browse Module

MeSH Terms

ID	Term
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000072638	Patient Portals

Ancestor Terms

ID	Term
D055991	Health Records, Personal
D008499	Medical Records
D011996	Records
D003625	Data Collection

Browse Leaves

Not provided

Browse Branches

Not provided