Child SleepNCT06970392
Brief Sleep Intervention for Bedtime Resistance
A study testing Bedtime Pass in people with Child Sleep, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Child Sleep
- What is being tested?
- Bedtime Pass
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Existing receipt of more intensive sleep intervention; severe intellectual disability or other condition precluding participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Andrew Riley, 4022034574, rileyand@ohsu.edu
About this study
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
- Being tested
- Bedtime Pass
- Keywords
- Feasibility trial, Bedtime Resistance, Bedtime Pass, Primary Care, Integrated Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedtime PassBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Bedtime Pass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability Survey
Measured: Immediately post-intervention and 30 days post-intervention
Treatment Fidelity Checklist
Measured: Immediately post-intervention
Secondary outcomes (1)
Pediatric Insomnia Severity Index
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.
Measured: 30 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start29 May 2025
- Primary completionJul 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Riley, Oregon Health and Science University
- Investigators
- Andrew R Riley, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970392
- Sponsor's protocol ID
- STUDY00025469
- Status last verified
- Apr 2026
- First submitted
- 6 May 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual data will be available from the PI upon request .
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Sleep Intervention for Bedtime Resistance
- ClinicalTrials.gov ID
- NCT06970392
- Acronym / sponsor ID
- STUDY00025469
- Conditions
- Child Sleep
- Keywords
- Feasibility trial, Bedtime Resistance, Bedtime Pass, Primary Care, Integrated Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 29 May 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bedtime Pass | Experimental | Behavioral: Bedtime PassThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Existing receipt of more intensive sleep intervention; severe intellectual disability or other condition precluding participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bedtime PassThe 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. | Behavioural | Bedtime Pass |
Primary outcome
Acceptability Survey
Time frame: Immediately post-intervention and 30 days post-intervention
Treatment Fidelity Checklist
Time frame: Immediately post-intervention
1 secondary outcome
Pediatric Insomnia Severity Index
Time frame: 30 days post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Yes. Individual data will be available from the PI upon request .
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew R Riley principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bedtime Pass in people with Child Sleep, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew R Riley, PhD (503-494-1724, rileyand@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability Survey (time frame: Immediately post-intervention and 30 days post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.