Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-27 @ 8:50 PM
Study NCT ID:
NCT06350292
Status:
RECRUITING
Last Update Posted:
2025-03-28
First Post:
2024-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SLEEP-COPE: Sleep Intervention for Oppositional Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D000096865', 'term': 'Oppositional Defiant Disorder'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2024-03-25', 'studyFirstSubmitQcDate': '2024-04-01', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-05', '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 parents that measure sleep efficiency, sleep onset latency, and total sleep time. Diaries also measure parenting techniques.'}], '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 Salivary Cortisol', 'timeFrame': 'before and after a cold-pressor task at 0 weeks, 6 weeks, 10 weeks', 'description': 'Salivary cortisol collected in the morning before and after cold-pressor task and immediately frozen. Saliva samples (25 µL) assayed in duplicate. At rest children will undergo the following: 1) baseline saliva collection, 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) post assessment saliva collection.'}, {'measure': 'Child Hair Cortisol', 'timeFrame': '0 weeks, 6 weeks, 10 weeks', 'description': 'Hair collected (15-50 mg) will be cut into 1 cm segments and ground into a fine powder before extracted with methanol for 16-18 hours while shaking. Cortisol then is quantified by liquid chromatography - tandem mass spectrometry (LC-MS/MS) (Salimetrics LLC, State College PA).'}, {'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': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insomnia Chronic', 'Oppositional Defiant Disorder']}, 'descriptionModule': {'briefSummary': 'Children with Oppositional Defiant Disorder (ODD) are at risk for insomnia, arousal dysfunction, mood problems, and noncompliance. Cognitive behavioral treatment for insomnia (CBT-I) holds promise for improving insomnia and related concerns. Telehealth delivery will reduce the burden of in-person sessions, particularly in areas where there is low mental healthcare access. Telehealth CBT-I is efficacious in adults and children but has not been tested in children with ODD. The proposed trial is the next logical step - development and iterative testing of SLEEP-COPE, a brief dyadic telehealth CBT-I for children with ODD and their parents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Child ages 8-12 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': 'NCT06350292', 'briefTitle': 'SLEEP-COPE: Sleep Intervention for Oppositional Children', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'SLEEP-COPE: Sleep Enhancement and Effective Parenting for Children with Oppositional and Problematic Expressions', 'orgStudyIdInfo': {'id': '0161464'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SLEEP: COPE', '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: SLEEP: COPE']}], 'interventions': [{'name': 'SLEEP: COPE', 'type': 'BEHAVIORAL', 'description': 'Standard CBT-I techniques along with modules targeting noncompliance in children with ODD and their parents.', 'armGroupLabels': ['SLEEP: COPE']}]}, '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 A Stearns, PhD', 'role': 'CONTACT', 'email': 'mstearns@usf.edu', 'phone': '8139748110'}]}, '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'}}}}