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Helping Young Children Sleep

Helping Young Children Sleep

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01729715
Enrollment
240
Registered
2012-11-20
Start date
2012-11-30
Completion date
2017-03-31
Last updated
2017-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Keywords

Pediatric, Insomnia

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.

Interventions

BEHAVIORALInternet
BEHAVIORALDVD

Sponsors

Nationwide Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Months to 36 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Brief infant sleep questionnaire3 weeksinfant sleep patterns and sleep problems

Secondary

MeasureTime frameDescription
Profile of mood states1 weekparental mood in the past week
Pittsburgh sleep quality index1 monthparental sleep patterns within the past month

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026