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Brief Sleep Intervention for Bedtime Resistance

Brief Sleep Intervention for Bedtime Resistance

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06970392
Enrollment
40
Registered
2025-05-14
Start date
2025-05-29
Completion date
2026-09-01
Last updated
2026-04-09

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

Conditions

Child Sleep

Keywords

Feasibility trial, Bedtime Resistance, Bedtime Pass, Primary Care, Integrated Care

Brief summary

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.

Interventions

BEHAVIORALBedtime Pass

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.

Sponsors

Oregon Health and Science University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Acceptability SurveyImmediately post-intervention and 30 days post-intervention
Treatment Fidelity ChecklistImmediately post-intervention

Secondary

MeasureTime frameDescription
Pediatric Insomnia Severity Index30 days post-interventionThe 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.

Countries

United States

Contacts

CONTACTAndrew R Riley, PhD
rileyand@ohsu.edu503-494-1724
CONTACTCassidy McDermott, PhD
mcdermott@ohsu.edu503-418-8236
PRINCIPAL_INVESTIGATORAndrew R Riley

Oregon Health and Science University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 10, 2026