Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT06012851
Status:
COMPLETED
Last Update Posted:
2024-12-04
First Post:
2023-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mobile Behavioral Parent Training for Childhood ADHD: A Micro-randomized Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-06-13', 'size': 407270, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-11-27T11:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'All participants receive access to a beta version of the mobile behavioral parent training application. Each participant is randomized multiple times per day (about 4-6 times per day) to received either no push notification (50% chance) or a push notification providing parenting feedback or a suggestion to use a parenting strategy (50% chance).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2023-08-22', 'studyFirstSubmitQcDate': '2023-08-22', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Passive Audio Data-Positive Sentiment Analysis', 'timeFrame': 'Through study completion, average of 5 weeks', 'description': 'Parent and child interaction behavior- proportion of recorded interaction that is labeled positive via sentiment analysis algorithm. This will be assessed during scheduled, daily audio recordings. Specifically, we will assess sentiment after the randomization of prompt delivery and prior to the next randomization.'}, {'measure': 'Passive Audio Data-Negative Sentiment Analysis', 'timeFrame': 'Throughout study completion, average of 5 weeks', 'description': 'Parent and child interaction behavior- proportion of recorded interaction that is labeled negative via sentiment analysis algorithm. This will be assessed during scheduled, daily audio recordings. Specifically, we will assess sentiment after the randomization of prompt delivery and prior to the next randomization.'}], 'secondaryOutcomes': [{'measure': 'Intervention Engagement', 'timeFrame': 'Through study completion, average of 5 weeks', 'description': 'Number of mobile BPT sessions completed divided by the total number of sessions available.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': 'The goal of the study is to develop and refine a personalized behavioral parent training intervention for caregivers of children with attention deficit hyperactivity disorder (ADHD). The behavioral intervention will teach positive parenting through videos and quizzes that caregivers can access through a smartphone application. The program also gives parents and caregivers in-the-moment feedback their use of parenting strategies. The current study, a micro-randomized trial, aims to see whether the in-the-moment feedback given to parents (a push notification on their smartphone) changes parenting behavior right after the feedback. Micro-randomized means that parents are randomly assigned repeatedly, in this study multiple times per day, to receive or not receive parenting feedback or suggestions on their smartphones.\n\nThe main questions to answer are:\n\nIs parenting feedback provided by a smartphone application acceptable to caregivers? When parents receive the feedback, do they use more positive parenting skills in the next few minutes compared to when they do not receive the feedback? Is the phone application usable and acceptable to parents and caregivers of children with attention deficit hyperactivity disorder?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently meets Diagnostic Statistical Manual 5 diagnostic criteria for ADHD\n* Ages 7 -12\n* Has parent-reported impairment in homework performance defined as a score of 3 or greater on an Impairment Rating Scale measure (Fabiano et al., 2006) of homework performance\n* Has at least one parent or primary caregiver who is willing to participate and is able to access the intervention at home via smartphone.\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT06012851', 'briefTitle': 'Mobile Behavioral Parent Training for Childhood ADHD: A Micro-randomized Trial', 'organization': {'class': 'OTHER', 'fullName': 'Florida International University'}, 'officialTitle': 'Personalizing Behavioral Parent Training: Improving Reach and Outcomes for Families of Children With Attention Deficit Hyperactivity Disorder (ADHD)', 'orgStudyIdInfo': {'id': '1R34MH128513-01', 'link': 'https://reporter.nih.gov/quickSearch/1R34MH128513-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mobile BPT with in-the-moment feedback', 'description': 'Participants will be randomized multiple times per day to receive a push notification that provides feedback about parenting.', 'interventionNames': ['Behavioral: Mobile behavioral parent training (mBPT)', 'Behavioral: In the moment feedback']}, {'type': 'EXPERIMENTAL', 'label': 'Mobile BPT with in-the-moment suggestions', 'description': 'Participants will be randomized multiple times per day to receive a push notification that provides a suggestion for a parenting behavior.', 'interventionNames': ['Behavioral: Mobile behavioral parent training (mBPT)', 'Behavioral: In the moment suggestions']}, {'type': 'OTHER', 'label': 'Mobile BPT only', 'description': 'Participants will be randomized multiple times per day to receive no push notification.', 'interventionNames': ['Behavioral: Mobile behavioral parent training (mBPT)']}], 'interventions': [{'name': 'Mobile behavioral parent training (mBPT)', 'type': 'BEHAVIORAL', 'description': 'The mobile phone application includes behavioral parent training content (for example, praise, effective commands, reward systems) delivered in videos, examples, and quizzes that parents/caregivers access.', 'armGroupLabels': ['Mobile BPT only', 'Mobile BPT with in-the-moment feedback', 'Mobile BPT with in-the-moment suggestions']}, {'name': 'In the moment feedback', 'type': 'BEHAVIORAL', 'description': 'In-the-moment feedback will include parenting feedback.', 'armGroupLabels': ['Mobile BPT with in-the-moment feedback']}, {'name': 'In the moment suggestions', 'type': 'BEHAVIORAL', 'description': 'In-the-moment feedback will include suggestions for parenting strategies.', 'armGroupLabels': ['Mobile BPT with in-the-moment suggestions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14226', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Center for Children and Families of Western New York', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}