Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-27 @ 4:22 AM
Study NCT ID:
NCT06970392
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-14
First Post:
2025-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brief Sleep Intervention for Bedtime Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2025-05-06', 'studyFirstSubmitQcDate': '2025-05-06', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability Survey', 'timeFrame': 'Immediately post-intervention and 30 days post-intervention'}, {'measure': 'Treatment Fidelity Checklist', 'timeFrame': 'Immediately post-intervention'}], 'secondaryOutcomes': [{'measure': 'Pediatric Insomnia Severity Index', 'timeFrame': '30 days post-intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Feasibility trial', 'Bedtime Resistance', 'Bedtime Pass', 'Primary Care', 'Integrated Care'], 'conditions': ['Child Sleep']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* Existing receipt of more intensive sleep intervention; severe intellectual disability or other condition precluding participation.'}, 'identificationModule': {'nctId': 'NCT06970392', 'briefTitle': 'Brief Sleep Intervention for Bedtime Resistance', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Brief Sleep Intervention for Bedtime Resistance', 'orgStudyIdInfo': {'id': 'STUDY00025469'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bedtime Pass', 'description': "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.", 'interventionNames': ['Behavioral: Bedtime Pass']}], 'interventions': [{'name': 'Bedtime Pass', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Bedtime Pass']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Andrew R Riley, PhD', 'role': 'CONTACT', 'email': 'rileyand@ohsu.edu', 'phone': '503-494-1724'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '5 years from the end of the study.', 'ipdSharing': 'YES', 'description': 'Individual data will be available from the PI upon request .', 'accessCriteria': 'Anonymized data will be available from the PI upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Andrew Riley', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}