Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-04-23 @ 1:59 PM
Study NCT ID:
NCT05683756
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2022-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Attention and Sleep Intervention Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2022-11-24', 'studyFirstSubmitQcDate': '2023-01-04', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Actigraphy', 'timeFrame': 'Change from baseline up to 8 months', 'description': 'Actigraphy is collected for 10 days at each of the three study timepoints. These data are to assess feasibility of actigraphy data collection with this population and will be used in exploratory analyses.'}, {'measure': 'Sleep Diary', 'timeFrame': 'Change from baseline up to 8 months', 'description': 'Sleep diary is collected for 10 days at each of the three study timepoints. These data are to assess feasibility of parent reported sleep diary data collection with this population and will be used in exploratory analyses.'}], 'primaryOutcomes': [{'measure': 'Intervention Acceptability', 'timeFrame': 'Post Intervention at approximately 4 months', 'description': 'Therapists and caregiver report of intervention acceptability will be assessed using the 4-item Acceptability of Intervention Measure (AIM), rated from 1-completely disagree to 5-completely agree, with scores greater than or equal to 16 indicating good acceptability.'}, {'measure': 'Intervention Appropriateness', 'timeFrame': 'Post Intervention at approximately 4 months', 'description': 'Therapists and caregiver report of intervention appropriateness will be assessed using the 4-item Intervention Appropriateness Measure (IAM), rated from 1-completely disagree to 5-completely agree, with scores greater than or equal to 16 indicating good appropriateness.'}, {'measure': 'Intervention Feasibility', 'timeFrame': 'Post Intervention at approximately 4 months', 'description': 'Therapists and caregiver report of intervention feasibility will be assessed using the 4-item Feasibility of Intervention Measure (FIM), rated from 1-completely disagree to 5-completely agree, with scores greater than or equal to 16 indicating good feasibility.'}, {'measure': 'Problematic Sleep', 'timeFrame': 'Change from baseline up to 8 months', 'description': "Using the Brief Child Sleep Questionnaire caregivers will report on their perception of child's sleep as problematic, rated 1 (Not at all) to 5 (A serious problem)."}, {'measure': 'ADHD Symptoms', 'timeFrame': 'Change from baseline up to 8 months', 'description': "Using the 18-item ADHD Rating Scale-IV-Preschool Version caregivers will report on the child's ADHD symptoms. Symptoms are rated from 0 (Rarely) to 3 (Very Often)."}], 'secondaryOutcomes': [{'measure': 'Nighttime Awakenings', 'timeFrame': 'Change from baseline up to 8 months', 'description': 'Caregivers will report how many times their child typically wakes during the night, using the Brief Child Sleep Questionnaire.'}, {'measure': 'Sleep Latency', 'timeFrame': 'Change from baseline up to 8 months', 'description': 'Sleep latency will be determined by using the caregiver report of how long it typically takes their child to fall asleep (number of minutes), using the Brief Child Sleep Questionnaire.'}, {'measure': 'Consistency of Bedtime Routine', 'timeFrame': 'Change from baseline up to 8 months', 'description': 'Caregivers will report the number of days, in a typical week, they regularly put their child to bed at the same time (within 15 minutes), using the Brief Child Sleep Questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Attention Deficit and Disruptive Behavior Disorders', 'Attention Deficit Hyperactivity Disorder', 'Child, Preschool', 'Sleep', 'Sleep Disturbance']}, 'referencesModule': {'references': [{'pmid': '8847377', 'type': 'BACKGROUND', 'citation': 'Cunningham CE, Bremner R, Boyle M. Large group community-based parenting programs for families of preschoolers at risk for disruptive behaviour disorders: utilization, cost effectiveness, and outcome. J Child Psychol Psychiatry. 1995 Oct;36(7):1141-59. doi: 10.1111/j.1469-7610.1995.tb01362.x.'}, {'pmid': '40001155', 'type': 'RESULT', 'citation': 'Joseph HM, Levenson JC, Conlon RPK, Mannion K, Kipp HL, Gradian A, Wallace ML, Williamson AA. Optimizing Attention and Sleep Intervention Study (OASIS): a protocol for a pilot randomized controlled trial to compare parent behavioral interventions with and without sleep strategies delivered in pediatric primary care for preschool-aged children at risk of childhood ADHD. Pilot Feasibility Stud. 2025 Feb 25;11(1):22. doi: 10.1186/s40814-025-01600-0.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this pilot clinical effectiveness trial is to compare a brief parent behavioral intervention (PBI) to a modified sleep focused PBI (SF-PBI) delivered by therapists in pediatric primary care for families of children 3-5 years old with sleep problems and early ADHD symptoms.\n\nThe main aims are to:\n\nAim 1: Demonstrate the acceptability, feasibility, and appropriateness of the sleep focused PBI (SF-PBI) delivered in pediatric primary care for preschool-aged children (3-5 years old) at elevated risk for ADHD.\n\nAim 2: Examine change in target engagement (sleep) and ADHD symptoms among preschool-aged children at elevated risk for ADHD receiving SF-PBI compared to standard PBI.', 'detailedDescription': "Sleep problems may be one mechanism through which young children may be at risk for developing ADHD, although first line ADHD interventions, including parent behavioral interventions (PBIs), do not address sleep. Investigators will test a modified version of a PBI to target sleep disrupting behaviors for children 3-5 years old at elevated risk for ADHD. The intervention will be delivered by behavioral health therapists embedded in pediatric primary care to increase families' access to intervention. This pilot effectiveness trial is the first step towards developing an early intervention targeting sleep as a mechanism to reduce the prevalence, symptoms, and impairments associated with childhood ADHD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParent/Caregiver:\n\n* (1) Legal guardian is at least 18 years of age\n* (2) Reads and speaks English\n\nChild:\n\n* (1) 3-5 years of age\n* (2) Caregiver report of 4 or more ADHD symptoms\n* (3) Caregiver reports child\'s sleep as a "moderate" or "serious problem"\n* (4) English speaking\n* (5) Child receives care from participating pediatric primary care office\n\nExclusion Criteria:\n\n* (1) Sleep interfering medical diagnoses (e.g., narcolepsy, obstructive sleep apnea)\n* (2) Severe neurodevelopmental disorder'}, 'identificationModule': {'nctId': 'NCT05683756', 'acronym': 'OASIS', 'briefTitle': 'Optimizing Attention and Sleep Intervention Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Optimizing Attention and Sleep Intervention Study: A Pilot RCT to Compare Parent Behavioral Interventions With and Without Sleep Strategies Delivered in Pediatric Primary Care for Preschool-aged Children at Risk of Childhood ADHD', 'orgStudyIdInfo': {'id': 'STUDY22070096'}, 'secondaryIdInfos': [{'id': 'R34MH131993', 'link': 'https://reporter.nih.gov/quickSearch/R34MH131993', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Brief Parent Behavioral Intervention', 'description': 'A brief parent behavioral intervention with evidenced based strategies for treatment of ADHD.', 'interventionNames': ['Behavioral: Brief Parent Behavioral Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Sleep-Focused Parent Behavioral Intervention', 'description': 'A modified version of the brief parent behavioral intervention that specifically targets sleep disrupting behaviors.', 'interventionNames': ['Behavioral: Sleep-Focused Parent Behavioral Intervention']}], 'interventions': [{'name': 'Brief Parent Behavioral Intervention', 'type': 'BEHAVIORAL', 'description': 'PBI administered in pediatric primary care by an embedded therapist.', 'armGroupLabels': ['Brief Parent Behavioral Intervention']}, {'name': 'Sleep-Focused Parent Behavioral Intervention', 'type': 'BEHAVIORAL', 'description': 'SF-PBI administered in pediatric primary care by an embedded therapist.', 'armGroupLabels': ['Sleep-Focused Parent Behavioral Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16066', 'city': 'Cranberry Township', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Children's Community Pediatrics Bass Wolfson, Cranberry", 'geoPoint': {'lat': 40.68496, 'lon': -80.10714}}, {'zip': '15146', 'city': 'Monroeville', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Children's Community Pediatrics GIL Murrysville", 'geoPoint': {'lat': 40.42118, 'lon': -79.7881}}, {'zip': '16101', 'city': 'New Castle', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Children's Community Pediatrics Shenango", 'geoPoint': {'lat': 41.00367, 'lon': -80.34701}}, {'zip': '16105', 'city': 'New Castle', 'state': 'Pennsylvania', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': "Children's Community Pediatrics Neshannock", 'geoPoint': {'lat': 41.00367, 'lon': -80.34701}}, {'zip': '15206', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Children's Community Pediatrics GIL East Liberty", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15217', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Children's Community Pediatrics Bass Wolfson, Squirrel Hill", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'centralContacts': [{'name': 'Heather M Joseph, DO', 'role': 'CONTACT', 'email': 'liebherrh@upmc.edu', 'phone': '4122465338'}], 'overallOfficials': [{'name': 'Heather M Joseph, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor of Psychiatry and Pediatrics, University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'url': 'https://nda.nih.gov', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be shared upon publication or 1 year after the grant end date. Data will be available indefinitely.', 'ipdSharing': 'YES', 'description': 'Individual participant data collected during the trial will be shared, after deidentification, via the NIMH National Data Archive.', 'accessCriteria': 'Any NIMH NDA authorized users may request the data.'}, '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': 'Heather Joseph', 'investigatorAffiliation': 'University of Pittsburgh'}}}}