Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-30 @ 2:47 PM
Study NCT ID:
NCT04779333
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2021-02-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lifestyle Enhancement for ADHD Program 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2024-11-20', 'unreleaseDate': '2024-11-21'}, {'resetDate': '2024-12-16', 'releaseDate': '2024-11-21'}], 'estimatedResultsFirstSubmitDate': '2024-11-20'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-02', 'studyFirstSubmitDate': '2021-02-24', 'studyFirstSubmitQcDate': '2021-02-26', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of intervention on Physical Activity', 'timeFrame': 'Baseline to 10 weeks', 'description': 'Comparing within-subject pre to post activity (MVPA) using accelerometer data'}, {'measure': 'Effects of intervention on Physical Activity', 'timeFrame': 'Baseline to 20 weeks', 'description': 'Comparing within-subject pre to post activity (MVPA) using accelerometer data'}, {'measure': 'Effects of intervention on Physical Activity', 'timeFrame': 'Baseline to 1 year', 'description': 'Comparing within-subject pre to post activity (MVPA) using accelerometer data'}], 'secondaryOutcomes': [{'measure': 'Effects of LEAP participation on child executive function', 'timeFrame': 'Baseline to 10 weeks', 'description': "Evaluate effects of LEAP participation on the child's executive functioning using the parent reported BRIEF-2 measure"}, {'measure': 'Effects of LEAP participation on child executive function', 'timeFrame': 'Baseline to 20 weeks', 'description': "Evaluate effects of LEAP participation on the child's executive functioning using the parent reported BRIEF-2 measure"}, {'measure': 'Effects of LEAP participation on child executive function', 'timeFrame': 'Baseline to 1 year', 'description': "Evaluate effects of LEAP participation on the child's executive functioning using the parent reported BRIEF-2 measure"}, {'measure': 'Effects of LEAP participation on child ADHD symptoms', 'timeFrame': 'Baseline to 10 weeks', 'description': "Evaluate effects of LEAP participation on the child's ADHD symptoms using the Conners-3 Parent Rating Scale"}, {'measure': 'Effects of LEAP participation on child ADHD symptoms', 'timeFrame': 'Baseline to 20 weeks', 'description': "Evaluate effects of LEAP participation on the child's ADHD symptoms using the Conners-3 Parent Rating Scale"}, {'measure': 'Effects of LEAP participation on child ADHD symptoms', 'timeFrame': 'Baseline to 1 year', 'description': "Evaluate effects of LEAP participation on the child's ADHD symptoms using the Conners-3 Parent Rating Scale"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to increase physical activity (PA) in children with ADHD using a novel, family-based intervention that promotes PA within the context of evidence-based behavioral management training (BMT) for caregivers, enhanced with mobile health (mHealth) behavior change strategies.\n\nPrimary Objective: To evaluate the primary effects of a 9-week, family-based intervention (Lifestyle Enhancement for ADHD Program - LEAP) to promote PA in young children with ADHD\n\nSecondary: To evaluate secondary effects of the LEAP program on child ADHD symptoms and executive functioning', 'detailedDescription': "This is a randomized trial comparing the LEAP program to standard BMT for ADHD (without the enhanced focus on health behaviors, mHealth technology, or social media). Specifically, 80 families will be randomized to receive either LEAP or a standard BMT program based on Russell Barkley's Defiant Children intervention manual. Moderators (e.g., child sex, medication, BMI) and mediators (e.g., change in PA) will be analyzed as exploratory outcomes. Hypotheses being tested include: 1) LEAP will be successful in increasing PA in children with ADHD in the short-term and over a year, more so than standard BPT and 2) children randomized to LEAP will exhibit greater and more sustained improvement in clinical outcomes relative to standard BMT. If successful, the R33 phase will inform the development of a larger and longer, confirmatory trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria (child):\n\n* Age 6-10 years\n* ADHD diagnosis\n* CGI-S rating ranging from 4 to 7.\n* Child not wearing a wrist-worn activity tracker more than 50% of days in the past month\n\nInclusion Criteria (caregiver):\n\n* One adult custodial caregiver (resides with the child at least 50% of the time) willing to participate in the study and complete baseline/follow-up measures\n* Caregiver able to complete forms in English\n* Caregiver owns a smart phone or similar Garmin compatible mobile device (e.g. iPod Touch) or willing to borrow iPod from study coordinators during the study period\n* Agree to install and share data from the Garmin smart phone app with investigators\n\nInclusion Criteria (supplementary caregiver):\n\n* An additional caregiver designated by the participating caregiver who provides care for the participating child on at least one occasion every other week\n* Able to participate in one or more group sessions\n* Able to consent in English\n\nExclusion Criteria (children):\n\n* \\- Younger than 6 years old or older than 10 years old\n* Do not meet criteria currently for ADHD diagnosis\n* Meet diagnostic criteria for psychiatric co-morbidities of Autism Spectrum Disorder, Depressive Disorder, Mood Disorder, Psychotic Disorder, or Intellectual Disability (by history)\n* Per caregiver report, engage in \\>60 min/day of MVPA consistently for at least 5 days per week\n* Any physical or medical restrictions on PA\n* Child currently/previously used a wearable physical activity sensing device at least 50% of days in the past month\n\nExclusion Criteria (caregiver):\n\n\\- Caregiver participated in an evidence-based parent behavior management training program (i.e., Incredible Years, Triple P, PCIT, Barkley's Defiant Child) in the past 24 months.\n\nExclusion Criteria (supplementary caregiver): none"}, 'identificationModule': {'nctId': 'NCT04779333', 'acronym': 'LEAP', 'briefTitle': 'Lifestyle Enhancement for ADHD Program 2', 'organization': {'class': 'OTHER', 'fullName': "Seattle Children's Hospital"}, 'officialTitle': 'Lifestyle Enhancement for ADHD Program (LEAP) Study 2', 'orgStudyIdInfo': {'id': 'STUDY00002356'}, 'secondaryIdInfos': [{'id': 'R33AT010041', 'link': 'https://reporter.nih.gov/quickSearch/R33AT010041', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LEAP Group', 'description': 'In addition to the components of the BMT group, the LEAP program includes an emphasis on supporting optimal physical activity, limiting screen time, and encouraging adequate sleep. The child and caregiver are also given a wrist-worn activity tracker and caregivers participate in a motivational Facebook group.', 'interventionNames': ['Behavioral: LEAP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BMT Group', 'description': 'The BMT Group will take part in a family-based intervention within the context of evidence-based behavioral management training (BMT) for caregivers. Standard BMT represents the current standard of care for childhood ADHD.', 'interventionNames': ['Behavioral: Standard BMT']}], 'interventions': [{'name': 'LEAP', 'type': 'BEHAVIORAL', 'description': 'LEAP will be delivered through the typical 9 weekly BMT group sessions lasting 90 minutes. Plus wrist worn activity tracker \\& facebook group.', 'armGroupLabels': ['LEAP Group']}, {'name': 'Standard BMT', 'type': 'BEHAVIORAL', 'description': 'Weekly BMT groups sessions which follow the Barkley curriculum', 'armGroupLabels': ['BMT Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98145', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Research Institute", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Pooja Tandon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seattle Children's Hospital"}, {'name': 'Erin Gonzalez, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seattle Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Seattle Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Pooja Tandon', 'investigatorAffiliation': "Seattle Children's Hospital"}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-11-20', 'type': 'RELEASE'}, {'date': '2024-11-21', 'type': 'UNRELEASE'}, {'date': '2024-11-21', 'type': 'RELEASE'}, {'date': '2024-12-16', 'type': 'RESET'}], 'unpostedResponsibleParty': "Pooja Tandon, Principal Investigator, Seattle Children's Hospital"}}}}