Brief Sleep Intervention for Bedtime Resistance

NCT06970392 | Recruiting

• 1 other identifier: STUDY00025469
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Acceptability Survey

  Immediately post-intervention and 30 days post-intervention

• Treatment Fidelity Checklist

  Immediately post-intervention

Secondary Outcomes (1)

• Pediatric Insomnia Severity Index

  30 days post-intervention

Study Arms (1)

Bedtime Pass

EXPERIMENTAL

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.

Behavioral: Bedtime Pass

Interventions

Bedtime Pass 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.

Bedtime Pass

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify if:

• Existing receipt of more intensive sleep intervention; severe intellectual disability or other condition precluding participation.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

Study Officials

• Andrew R Riley

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew R Riley, PhD

CONTACT

503-494-1724; rileyand@ohsu.edu

Cassidy McDermott, PhD

CONTACT

503-418-8236; mcdermott@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: May 29, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 5 years from the end of the study.
• Access Criteria: Anonymized data will be available from the PI upon request.

Locations

US (1)