Health TrialsbyHealthPanel

Brief Sleep Intervention for Bedtime Resistance

ConditionChild Sleep
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOregon Health and Science University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Bedtime PassExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Acceptability Survey

Time frame
Immediately post-intervention and 30 days post-intervention
2

Treatment Fidelity Checklist

Time frame
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.

Time frame
30 days post-intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oregon Health and Science University

Lead sponsor

Source ClinicalTrials.gov
Apply now