NCT01729715

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

3 years

First QC Date

November 15, 2012

Last Update Submit

July 19, 2017

Conditions

Insomnia

Keywords

PediatricInsomnia

Outcome Measures

Primary Outcomes (1)

  • Brief infant sleep questionnaire

    infant sleep patterns and sleep problems

    3 weeks

Secondary Outcomes (2)

  • Profile of mood states

    1 week

  • Pittsburgh sleep quality index

    1 month

Study Arms (3)

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

InternetBEHAVIORAL
Internet
DVDBEHAVIORAL
DVD

Eligibility Criteria

Age6 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • months
  • difficulties falling asleep or staying asleep
  • DVD and internet access

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Patient Portals

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Health Records, PersonalMedical RecordsRecordsData CollectionEpidemiologic MethodsInvestigative Techniques

Study Officials

  • Mark Splaingard, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. and Dir. of pediatric sleep medicine

Study Record Dates

First Submitted

November 15, 2012

First Posted

November 20, 2012

Study Start

November 1, 2012

Primary Completion

November 1, 2015

Study Completion

March 1, 2017

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

US(1)