Recruiting

Sleep Intervention

Sponsor:

Oregon Health and Science University

Code:

NCT06970392

Conditions

Child Sleep

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bedtime Pass

Study Details

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.

Conditions

Child Sleep

Study ID

NCT06970392

Start date

May 29, 2025

Status verified date

Apr, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Bedtime Pass

The behavioral health consultant will converse with the participant about the child's bedtime resistance, bedtime routine, and other variables that may impact sleep. The behavioral health consultant will provide psychoeducation on sleep hygiene and provide relevant handouts. The behavioral health consultant will also explain the Bedtime Pass Intervention and provide relevant materials. The participant will have the opportunity to ask questions about implementing the intervention at home with their child.

Interventions

Bedtime 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.

Primary outcome measure

  • Acceptability Survey [ Time Frame: Immediately post-intervention and 30 days post-intervention ]
  • Treatment Fidelity Checklist [ Time Frame: Immediately post-intervention ]

Central Contacts and Locations

Central contacts

Andrew R Riley, PhD

503-494-1724rileyand@ohsu.edu

Cassidy McDermott, PhD

503-418-8236mcdermott@ohsu.edu

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Andrew Riley

4022034574rileyand@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Apr 9, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2026-04-09.