40 Participants NeededMy employer runs this trial

Bedtime Pass for Childhood Sleep

AR
CM
Overseen ByCassidy McDermott, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Oregon Health and Science University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new, simple method to help young children, aged 3 to 7, who struggle to fall asleep independently. The treatment involves educating parents on good sleep habits and using a "Bedtime Pass," a tool to manage bedtime resistance. The goal is to ensure that healthcare providers can easily deliver the intervention during regular doctor visits and that it benefits families. This trial suits caregivers with children who face bedtime resistance and already receive primary care at participating locations. As an unphased trial, it allows families to contribute to research that could simplify bedtime routines for many.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Bedtime Pass intervention is safe for children?

Research has shown that the Bedtime Pass is a safe and well-accepted method for helping young children who resist bedtime. One study found that this approach reduced bedtime problems without negative effects. Pediatricians consider the Bedtime Pass a very good option, favorably comparing it to other common methods like co-sleeping or ignoring bedtime resistance. For some children, the pass completely eliminated bedtime issues, demonstrating its potential effectiveness and safety for home use.12345

Why are researchers excited about this trial?

The Bedtime Pass is unique because it offers a behavioral approach to managing childhood sleep issues, specifically bedtime resistance. Unlike traditional methods that may rely on medication or strict sleep schedules, the Bedtime Pass involves psychoeducation on sleep hygiene and empowering parents with a flexible tool to manage bedtime routines. This intervention allows for a more personalized and less invasive solution, aiming to improve sleep patterns by addressing the root behavioral causes. Researchers are excited about this trial because it explores a non-pharmacological option that could offer lasting benefits for children and their families.

What evidence suggests that the Bedtime Pass is effective for improving childhood sleep?

Research has shown that the Bedtime Pass, which participants in this trial will use, helps reduce bedtime struggles in children. One study found that children using the Bedtime Pass called out and left their rooms much less often than those who didn't use it. Another study reported high parental satisfaction with this method. For some families, it completely resolved bedtime issues, with benefits lasting up to three months. Overall, the Bedtime Pass offers a simple and effective way to help children fall asleep independently with fewer bedtime challenges.23678

Who Is on the Research Team?

AR

Andrew R Riley

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for parents of children aged 3-7 who have trouble going to bed on their own and get primary care at the study clinics. Families must speak English.

Inclusion Criteria

I am an English-speaking caregiver of a 3-7 year old with bedtime resistance in primary care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Behavioral health consultant delivers a brief sleep intervention including education on sleep hygiene and the Bedtime Pass during routine primary care visits

1 week
1 visit (in-person)

Follow-up

Participants are monitored for changes in sleep patterns and insomnia severity post-intervention

4 weeks
1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Bedtime Pass

Trial Overview

The study tests a brief sleep program, including education about healthy sleep habits and using a 'Bedtime Pass,' delivered by a behavioral health consultant during regular doctor visits. There is no comparison group.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Bedtime PassExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials
1,024
Recruited
7,420,000+

Citations

Treating Bedtime Resistance with the Bedtime Pass - PMC - NIH

First, the results show that the pass effectively reduced bedtime resistance in 3-year-old children who were the only targets of the intervention (as distinct ...

An Approach to Bedtime Crying and Leaving the Room

In our study, the bedtime pass reduced the frequency of bedtime problems to zero rates in the 2 primary participants without adverse effects and was rated as an ...

Evaluating the Bedtime Pass Program for Child Resistance ...

Parents reported high levels of satisfaction and treatment acceptability. Conclusions BPP is a noncomplex, socially acceptable, effective treatment for bedtime ...

Brief Sleep Intervention for Bedtime Resistance

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 ...

Bedtime Pass program curbs sleep resistance

Results showed that children in the intervention group called out and cried less often than the control group at post-test, and there was no extinction burst.

CE corner: Helping children get a good night's sleep

Interventions include behavioral treatments for insomnia and bedtime resistance in young children, and insomnia and delayed sleep-wake phase ...

Behavioral sleep interventions in children aged 0-5 years

Brief report: evaluating the bedtime pass program for child resistance to bedtime--a randomized, controlled trial. J Pediatr Psychol, 32 (2007), pp. 283-287 ...

The Bedtime Pass Helps Parents And Kids Skip The Sleep ...

"Pediatricians rated the pass as significantly more acceptable than letting children sleep with parents and equivalent to ignoring. Parents ...