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Recruiting NCT06970392

Brief Sleep Intervention for Bedtime Resistance

No phase Interventional Child Sleep

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bedtime Pass.
Who it may be relevant to
Registry conditions: Child Sleep. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Behavioral 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 measures

  • Acceptability Survey [Time frame: Immediately post-intervention and 30 days post-intervention]
  • Treatment Fidelity Checklist [Time frame: Immediately post-intervention]
Secondary outcome measures (1)
  • Pediatric Insomnia Severity Index [Time frame: 30 days post-intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Oregon Health & Science University — Portland

Identifiers

NCT: NCT06970392 · STUDY00025469

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗