Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-25 @ 1:44 PM
Study NCT ID:
NCT06239792
Status:
COMPLETED
Last Update Posted:
2025-11-06
First Post:
2024-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Promotion Program Primary Care (SPP PC) Open Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D012892', 'term': 'Sleep Deprivation'}], 'ancestors': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-05-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-04', 'studyFirstSubmitDate': '2024-01-24', 'studyFirstSubmitQcDate': '2024-01-24', 'lastUpdatePostDateStruct': {'date': '2025-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Intervention Measure', 'timeFrame': 'Post-Intervention (~8 weeks)', 'description': 'The Feasibility of Intervention Measure (FIM) is a 4-item measure that assesses the feasibility of the intervention, each item is scored on a 1-5 likert scale (completely disagree to completely agree). Items can be evaluated individually or a scale can be created by averaging responses. Scale values range from 1-5.'}, {'measure': 'Acceptability of Intervention Measure', 'timeFrame': 'Post-Intervention (~8 weeks)', 'description': 'The Acceptability of Intervention Measure (AIM) is a 4-item measure that assesses the acceptability of the intervention, each item is scored on a 1-5 likert scale (completely disagree to completely agree). Items can be evaluated individually or a scale can be created by averaging responses. Scale values range from 1-5.'}, {'measure': 'Intervention Appropriateness Measure', 'timeFrame': 'Post-Intervention (~8 weeks)', 'description': 'The Intervention Appropriateness Measure (IAM) is a 4-item measure that assesses the appropriateness of the intervention, each item is scored on a 1-5 likert scale (completely disagree to completely agree). Items can be evaluated individually or a scale can be created by averaging responses. Scale values range from 1-5.'}, {'measure': 'Clinical Global Impressions Scale - Improvement', 'timeFrame': 'Post-Intervention (~8 weeks)', 'description': 'This is a clinician rating of improvement in sleep and psychopathology. Clinicians rate domains of sleep health, psychiatric symptoms, and overall health on a range from 1 very much improved) to 7 (very much worse). A score of 0 indicates no assessment. Scores for each domain are reported individually.'}, {'measure': 'Patient Health Questionnaire - 9 - M', 'timeFrame': 'Change Screening to Post-Intervention (~10 weeks)', 'description': 'This is a self-report measure of depressive symptoms. It consists of 9 items rated 0 (not at all) to 3 (nearly every day) over the past 2 weeks. Scores on those 9 items are summed to create a total score (0-27, higher score indicates greater depression).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep', 'Sleep Disturbance', 'Insufficient Sleep']}, 'descriptionModule': {'briefSummary': 'Investigators developed a brief, scalable, behavioral Sleep Promotion Program (SPP) for adolescents with short sleep duration and sleep-wake irregularity, which relies on one individual session and smart phone technology to deliver evidence-based strategies. This open trial portion of the R34 will focus on conducting an open trial (n=8) to iteratively refine provider training, implementation procedures, and SPP program, per participant and staff feedback.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nYouth:\n\n* Able and willing to provide informed assent (with consent from parent/guardian)\n* Ages 12-18\n* Currently a patient at Kids Plus Pediatrics\n* Currently depressed\n* Report short sleep duration (\\<7 hours on school nights) and/or weekday-weekend sleep timing difference of \\>=2 hours\n\nParents:\n\nParents must be age 18 or older and the parent/guardian of an enrolled youth participant and must have at least 10 hours face-to-face interaction with the youth participant per week.\n\nExclusion Criteria:\n\nYouth:\n\n* Significant or unstable medical conditions\n* Diagnosis of sleep apnea, narcolepsy, restless leg syndrome, nightmare disorder, or periodic limb movement disorder\n* Diagnosis of PTSD, bipolar disorder, a psychotic disorder, or substance use disorder\n* Currently engaged in cognitive and/or behavioral therapy that aims to improve sleep\n* Changes in medications in the month prior to screening\n* Active suicidality requiring immediate treatment\n* Unable or unwilling to comply with study procedures\n* Have any physical or mental condition that would preclude study participation.\n\nParents will be excluded if they:\n\n* Express active suicidality that requires immediate treatment;\n* Have any physical or mental condition that would preclude study participation; OR\n* Are unable or unwilling to comply with study procedures.'}, 'identificationModule': {'nctId': 'NCT06239792', 'acronym': 'SPP OT', 'briefTitle': 'Sleep Promotion Program Primary Care (SPP PC) Open Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'A Sleep Promotion Program for Depressed Adolescents in Pediatric Primary Care Open Trial', 'orgStudyIdInfo': {'id': 'STUDY23010211 (Open)'}, 'secondaryIdInfos': [{'id': 'R34MH132724', 'link': 'https://reporter.nih.gov/quickSearch/R34MH132724', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sleep Promotion Program', 'description': 'Participants will receive the Sleep Promotion Program (SPP), consisting of 2 individual sessions with a clinician via telehealth (or in-person if desired), about 2 weeks apart, and web-based intervention components.', 'interventionNames': ['Behavioral: Sleep Promotion Program']}], 'interventions': [{'name': 'Sleep Promotion Program', 'type': 'BEHAVIORAL', 'otherNames': ['SPP'], 'description': "SPP prioritizes increasing sleep duration and regularizing sleep-wake timing. The provider and youth review the youth's sleep pattern, based on sleep diary data collected before and during the program and actigraphy data collected at baseline. They discuss benefits to the current sleep pattern, reasons for changing sleep, and they create an action plan. Psychoeducation about healthy sleep is offered via a handout developed by our group. Youth and provider jointly select SPP strategies relevant to the contributors to poor sleep for each youth (e.g., time management, limiting weekend oversleep). In the second session they review progress and adjust the plan. Parents participate for part of each session to learn about their child's sleep and to discuss ways they can support their child to make the planned changes.", 'armGroupLabels': ['Sleep Promotion Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15217', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Jessica C Levenson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'All quantitative data will be cleaned and available for addressing other research questions (those not described in funded/pending grants) within one year of the completion of the study.', 'ipdSharing': 'YES', 'description': "In accordance with the National Insitute of Mental Health (NIMH) Data Archive Data Use Certification, investigators will share data collected as part of this proposal with outside investigators. To access data from this study, outside investigators will be asked to submit a proposal that incudes project aims and hypotheses, variables and analytic approach, and rationale for the proposed analysis. The proposal would also include information on how and where the data will be used, investigators' qualifications, timeframe in which data will be analyzed/submitted/published, source of financial support, and conflict of interest statement. They will be asked to sign a data sharing agreement and confidentiality statement prior to the sharing of this data.", 'accessCriteria': 'Access to data will be provided to those meeting our pre-requesites through the National Database for Clinical Trials (NDCT) Data Access Committee (DAC). Only Investigators and Institutions who have met security measures and have submitted a Data Use Certification co-signed by the PI and the designated Institutional Official at the NIH-recognized sponsoring institution with a current Federal Wide Assurance will be given access. Outside Investigators will be asked to acknowledge the grant that supported the data collection and management in all publications and presentations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jessica Levenson', 'investigatorAffiliation': 'University of Pittsburgh'}}}}