Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-01-04 @ 9:32 AM
Study NCT ID:
NCT06410495
Status:
RECRUITING
Last Update Posted:
2025-03-28
First Post:
2024-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Dyadic Family Based Intervention to Improve Sleep in Children with ODD and Their Parents: NiteCAPP SINCC (Pilot)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000096865', 'term': 'Oppositional Defiant Disorder'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2024-05-07', 'studyFirstSubmitQcDate': '2024-05-07', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child Daily Sleep Diaries', 'timeFrame': 'Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks', 'description': 'Daily diaries filled out by children with parent assistance that measure sleep efficiency, sleep onset latency, and total sleep time. Diaries also measure child behavior.'}, {'measure': 'Parent Daily Sleep Diaries', 'timeFrame': 'Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks', 'description': 'Daily diaries filled out by parent that measure sleep efficiency, sleep onset latency, and total sleep time. Diaries also measure child behavior.'}], 'secondaryOutcomes': [{'measure': 'Child Actigraphy', 'timeFrame': '24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks', 'description': 'Physiological measure of sleep efficiency, sleep onset latency, and total sleep time'}, {'measure': 'Parent Actigraphy', 'timeFrame': '24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks', 'description': 'Physiological measure of sleep efficiency, sleep onset latency, and total sleep time'}, {'measure': 'Child Heartrate Variability', 'timeFrame': 'during a cold-pressor task at 0 weeks, 6 weeks, 10 weeks', 'description': 'Child heartrate variability will be measured during the following: 1) resting state, 2) cold pressor stimulation to hand (place hand to bottom of 4° Celsius ice water) for 30 secs, 3) 3 min recovery, 4) cold pressor stimulation to other hand for 30secs, 5) resting state'}, {'measure': 'Parent Heartrate Variability', 'timeFrame': 'during a cold-pressor task at 0 weeks, 6 weeks, 10 weeks', 'description': 'Parent heartrate variability will be measured during the following: 1) resting state, 2) cold pressor stimulation to hand (place hand to bottom of 4° Celsius ice water) for 30 secs, 3) 3 min recovery, 4) cold pressor stimulation to other hand for 30secs, 5) resting state'}, {'measure': 'The Revised Childhood Anxiety and Depression Scale', 'timeFrame': '0 weeks, 6 weeks, 10 weeks', 'description': 'Measures child anxiety and depression'}, {'measure': 'PROMIS Child Sleep Disturbance', 'timeFrame': '0 weeks, 6 weeks, 10 weeks', 'description': 'Measures child sleep'}, {'measure': 'Alabama Parenting Questionnaire', 'timeFrame': '0 weeks, 6 weeks, 10 weeks', 'description': 'Measures parenting behaviors'}, {'measure': 'Perceived Stress Scale', 'timeFrame': '0 weeks, 6 weeks, 10 weeks', 'description': 'Measures parent stress'}, {'measure': 'Child Disruptive Behavior Disorders Checklist', 'timeFrame': '0 weeks, 6 weeks, 10 weeks', 'description': 'Measures child disruptive behaviors'}, {'measure': 'Beck Depression Inventory-II', 'timeFrame': '0 weeks, 6 weeks, 10 weeks', 'description': 'Measures parent depression'}, {'measure': 'State-Trait Anxiety Inventory', 'timeFrame': '0 weeks, 6 weeks, 10 weeks', 'description': 'Measures parent anxiety'}, {'measure': 'PROMIS Adult Sleep Disturbance', 'timeFrame': '0 weeks, 6 weeks, 10 weeks', 'description': 'Measures parent sleep'}, {'measure': 'Pediatric Sleep Questionnaire', 'timeFrame': '0 weeks, 6 weeks, 10 weeks', 'description': 'Measures child sleep apnea risk'}, {'measure': 'Epworth Sleepiness Scale', 'timeFrame': '0 weeks, 6 weeks, 10 weeks', 'description': 'Measures parent sleep apnea risk'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oppositional Defiant Disorder', 'Insomnia Chronic']}, 'descriptionModule': {'briefSummary': 'In this proposal a brief web-based cognitive behavioral treatment for insomnia (CBT-I) for children with oppositional defiant disorder (ODD) and their parents is iteratively adapted and tested for acceptability, feasibility, and preliminary efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Child ages 8-17 with ODD (prior diagnosis) and insomnia\n2. Child and parent English proficiency.\n\nInsomnia:\n\n1. complaints of difficulties falling asleep, staying asleep, or early morning awakening by child report or parent observation for 3+ mos\n2. daytime dysfunction (mood, cognitive, social, academic) due to insomnia\n3. baseline diaries and actigraphy indicate \\>30 mins. of sleep onset latency, wake after sleep onset, or early morning awakening (time between last awakening and out of bed time) on 6+ nights\n\nExclusion criteria:\n\n1. Parent unable to provide informed consent or child unable to provide assent\n2. Family unwilling to accept random assignment\n3. Child/parent participation in another randomized research project\n4. Parent unable to complete forms or implement treatment procedures due to cognitive impairment\n5. Child untreated medical comorbidity, including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation/intent, \\[frequent\\] parasomnias)\n6. Child psychotropic or other medications that alter sleep with the exceptions of stimulants, sleep medications, and/or melatonin\n7. Child participation in non-pharmacological treatment (including CBT) for sleep outside current trial\n8. Parent report of inability to undergo Holter Monitoring or actigraphy (e.g., extreme sensitivity, behavioral outbursts)\n9. Other conditions adversely affecting trial participation'}, 'identificationModule': {'nctId': 'NCT06410495', 'briefTitle': 'Digital Dyadic Family Based Intervention to Improve Sleep in Children with ODD and Their Parents: NiteCAPP SINCC (Pilot)', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'Digital Dyadic Family Based Intervention to Improve Sleep in Children with ODD and Their Parents: NiteCAPP SINCC (Pilot)', 'orgStudyIdInfo': {'id': '6595'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NiteCAPP SINCC', 'description': 'Content includes both standard CBT-I techniques \\[sleep hygiene, stimulus control, sleep restriction, cognitive therapy\\] as well as those targeting children with ODD and their parents. Active child participation is a goal but may be limited due to age/abilities. Parents will work with children to implement behavioral strategies.', 'interventionNames': ['Behavioral: NiteCAPP SINCC']}], 'interventions': [{'name': 'NiteCAPP SINCC', 'type': 'BEHAVIORAL', 'description': 'Standard CBT-I techniques along with modules targeting noncompliance in children with ODD and their parents.', 'armGroupLabels': ['NiteCAPP SINCC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33620-8100', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Melanie Stearns, PhD', 'role': 'CONTACT', 'email': 'mstearns@usf.edu'}], 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'centralContacts': [{'name': 'Melanie Stearns, PhD', 'role': 'CONTACT', 'email': 'mstearns@usf.edu', 'phone': '8123828872'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Melanie Stearns', 'investigatorAffiliation': 'University of South Florida'}}}}