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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability Survey | Immediately post-intervention and 30 days post-intervention | |
| Treatment Fidelity Checklist | Immediately post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew R Riley, PhD | Contact | 503-494-1724 | rileyand@ohsu.edu | |
| Cassidy McDermott, PhD | Contact | 503-418-8236 | mcdermott@ohsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Andrew R Riley | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Recruiting | Portland | Oregon | 97239 | United States |
Individual data will be available from the PI upon request .
5 years from the end of the study.
Anonymized data will be available from the PI upon request.
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| 30 days post-intervention |