Oregon Health & Science University
Portland, Oregon, 97239, United States
Location status: Recruiting
Recruiting
NCT Number: NCT06970392
Brief Sleep Intervention for Bedtime Resistance
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- Existing receipt of more intensive sleep intervention; severe intellectual disability or other condition precluding participation.
Treatment and study plan
Bedtime Pass
BehavioralThe 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.
Primary outcomes
-
Acceptability Survey
Time frame: Immediately post-intervention and 30 days post-intervention
-
Treatment Fidelity Checklist
Time frame: Immediately post-intervention
Secondary outcomes
-
Pediatric Insomnia Severity Index
Time frame: 30 days post-intervention
The Pediatric Insomnia Severity Index (PISI) is a 6-item, parent-report questionnaire (for children 4-10 years old) designed to measure the severity of insomnia symptoms, including difficulty falling asleep, staying asleep, and daytime impairment. It uses a 6-point scale to measure frequency, with higher scores (0-30) indicating more severe insomnia, and has demonstrated reliability and validity.
Study contacts
Contact information is provided by the study sponsor or research team.
Andrew R Riley, PhD
CONTACT
Cassidy McDermott, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Oregon Health and Science University
Other
Registry information
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- May 14, 2025
- Registry last updated
- Apr 9, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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