Helping Young Children Sleep

NCT ID: NCT01729715

Last Updated: 2017-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2017-03-31

Brief Summary

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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

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Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Internet

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

Group Type EXPERIMENTAL

Internet

Intervention Type BEHAVIORAL

DVD

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

Group Type EXPERIMENTAL

DVD

Intervention Type BEHAVIORAL

No treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Internet

Intervention Type BEHAVIORAL

DVD

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mark Splaingard

Prof. and Dir. of pediatric sleep medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark Splaingard, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB12-00439

Identifier Type: -

Identifier Source: org_study_id

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