What this study is
This is non-controlled feasibility study testing the delivery of a brief sleep intervention for children aged 3-7 who struggle to fall asleep independently. The interventions is designed to be delivered by a behavioral health consultant during routine primary care visits. The treatment components consist of education about good sleep hygiene and the "Bedtime Pass." The hypotheses are that the intervention will be delivered with fidelity in the time allotted, and that parents will rate the intervention as feasible and acceptable.
What's being tested
- Bedtime Pass
Intervention · BEHAVIORAL
The Bedtime Pass is a small paper card that children will be allowed to exchange for a trip out of their bedroom after bedtime. Once the card has been exchanged, participants will be instructed to ignore any additional pleas from their child. Participants will also be provided with general information about good sleep hygiene.
Study details
- Sponsor
- Oregon Health and Science University
- Conditions
- Child Sleep
- Enrolling
- 40 people
- Starts
- 2025-05-29
- Est. completion
- 2026-09
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Caregiver of a child aged 3-7 years who receives primary care services who endorses their child demonstrating bedtime resistance; English-speaking; receiving primary care at the study locations.
You can't join if
- Existing receipt of more intensive sleep intervention; severe intellectual disability or other condition precluding participation.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openOregon Health & Science University
Portland, Oregon, United States
- Andrew Riley · Contact4022034574rileyand@ohsu.edu
Recruiting
Study team
Sponsor
Oregon Health and Science University
Study ID STUDY00025469
Principal investigator
Andrew R Riley
Oregon Health and Science University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.