Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT05145920
Status:
COMPLETED
Last Update Posted:
2023-04-25
First Post:
2021-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Encouraging Positive Parenting Habits Through Digital Media
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open, single-group trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-24', 'studyFirstSubmitDate': '2021-09-27', 'studyFirstSubmitQcDate': '2021-11-23', 'lastUpdatePostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'ADHD symptoms', 'timeFrame': '1 month', 'description': 'Strengths and Weakness of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior Scale (SWAN) inattention and hyperactivity/impulsivity symptoms total. Parent ratings completed before and after the intervention using a 7-point scale. Averaged across 18 items. Higher scores indicate ADHD symptoms more frequently observed.'}, {'measure': 'ODD symptoms', 'timeFrame': '1 month', 'description': 'SWAN oppositional/defiant symptoms total. Parent ratings completed before and after the intervention using a 7-point scale. Averaged across 8 items. Higher scores indicate ODD symptoms more frequently observed.'}, {'measure': 'Irritability', 'timeFrame': '1 month', 'description': 'Affective Reactivity Index (ARI). Parent ratings completed before and after the intervention using a 3-point scale. Averaged across 6 items. Higher scores indicate irritability more frequently observed.'}], 'primaryOutcomes': [{'measure': 'Number of videos viewed', 'timeFrame': '1 month', 'description': 'The number of videos viewed (minimum 0, maximum 5) to evaluate participant engagement.'}, {'measure': 'Percentage of completed daily ratings', 'timeFrame': '1 month', 'description': 'The percentage of completed daily ratings (minimum 0, maximum 17). Parents are asked to provide daily ratings on the degree of success in implementing parenting strategies taught.'}, {'measure': 'Participant satisfaction', 'timeFrame': '1 month', 'description': 'The parent-rated satisfaction regarding information presented in the videos. A rating completed after each video viewing using a 4-point scale. Averaged across the ratings completed for the videos viewed. (Minimum 0, maximum 4). Higher scores indicate greater satisfaction.'}], 'secondaryOutcomes': [{'measure': "Parent-rated child's difficulties with daily transitions", 'timeFrame': '1 month', 'description': "The parent-rated child's difficulties with 9 common daily transitions. Ratings completed before and after the intervention using a 3-point scale. Averaged across the ratings completed for the 9 transitions. Higher scores indicate greater difficulties."}, {'measure': "Parent-rated child's impairment related to transition difficulties", 'timeFrame': '1 month', 'description': 'The parent-rated level of impairment caused by transition difficulties (1 item). Ratings completed before and after the intervention using a 7 point scale. Higher scores indicate greater impairment.'}, {'measure': 'Proactive parenting', 'timeFrame': '1 month', 'description': 'Multidimensional Assessment of Parenting Scale (MAPS) Proactive Parenting sub-scale. Parent ratings completed before and after the intervention using a 5-point scale. Average across 6 items. Higher scores indicate more frequent use of proactive parenting strategies.'}, {'measure': 'Use of positive reinforcement', 'timeFrame': '1 month', 'description': 'MAPS Positive Reinforcement sub-scale. Parent ratings completed before and after the intervention using a 5-point scale. Average across 4 items. Higher scores indicate more frequent use of positive reinforcement strategies.'}, {'measure': 'Hostility toward child', 'timeFrame': '1 month', 'description': 'MAPS Hostility sub-scale. Parent ratings completed before and after the intervention using a 5-point scale. Average across 7 items. Lower scores indicate less frequent use of hostile reactions during parent-child interactions.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ADHD', 'Parent Training', 'Treatment Access'], 'conditions': ['ADHD']}, 'descriptionModule': {'briefSummary': 'This study evaluates the feasibility and preliminary impacts of a new parenting program consisting of a series of educational videos, delivered via a popular texting platform. For this pilot project, the program content is focused on teaching parents strategies to better manage one of the commonly reported challenges that children face, a transition to a non-preferred activity. Parents with young children demonstrating behavior consistent with ADHD and experiencing difficulties with daily transition routines are invited to participate in the study.', 'detailedDescription': 'This pilot study employs a pre-post, open trial design with the primary aim to investigate the feasibility of delivering parenting educational materials in a highly accessible format, i.e., a widely used texting platform. The training videos demonstrate the applications of antecedent- and reinforcement-based behavior management techniques in a specific situation and encourage parents to build positive parenting habits. The program usability and satisfaction will be assessed through ratings and answers to open-ended questions by participating parents. The study targets parents of children demonstrating symptoms of ADHD. These families frequently experience difficulties managing everyday routines at home, yet the access to psychosocial treatment is limited. The investigators expect parents to engage well in the program delivered via digital media. Based on the existing literature on the effectiveness of behavior parent training delivered in traditional in-person format, a moderate effect size is expected in the pre-post measures of parenting practices and the child target behavior for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '4 Years', 'genderBased': True, 'genderDescription': '4 years to 8 years (Child)', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Parents of children, aged 4-8, who demonstrate behavior symptoms consistent with ADHD symptoms, i.e., at least 4 inattention and/or 4 hyperactivity/impulsivity symptoms (parent-report). The number of symptoms is lower than the diagnostic threshold to include those with emerging problems. No diagnosis will be made or confirmed in the study. Children need to live with the participating parents at least 5 days per week every week.\n\nExclusion Criteria:\n\n* Parents of children who have received other forms of pharmacological and/or non-pharmacological treatment in the past 3 months. These parents will be asked to wait to receive other forms of treatment until they complete the study participation.\n\nParents of children demonstrating symptoms consistent with Autism Spectrum Disorder, and those other difficulties (severe learning, mood and anxiety problems and environmental issues \\[e.g., recent divorce\\]) that would better explain the child's challenges transition routines."}, 'identificationModule': {'nctId': 'NCT05145920', 'acronym': 'Habite', 'briefTitle': 'Encouraging Positive Parenting Habits Through Digital Media', 'organization': {'class': 'OTHER', 'fullName': "D'Or Institute for Research and Education"}, 'officialTitle': 'Encouraging Positive Parenting Habits Through Digital Media', 'orgStudyIdInfo': {'id': '50214221.6.0000.5249'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pilot testing of an education program promoting effective parenting habit', 'description': 'Parents will receive a series of 5 short videos via Whatsapp', 'interventionNames': ['Behavioral: HabitE (effective parenting habit) program (in Brazilian Portuguese)']}], 'interventions': [{'name': 'HabitE (effective parenting habit) program (in Brazilian Portuguese)', 'type': 'BEHAVIORAL', 'description': 'Parents who enroll in the program will receive a series of 5 videos (\\~ 7 minutes each), 1 video at a time, generally every 3 days. Parents will also receive daily written texts, which include implementation tips and an assessment of a target (transition) behavior.', 'armGroupLabels': ['Pilot testing of an education program promoting effective parenting habit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22281-100', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': "D'Or Institute for Research", 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'overallOfficials': [{'name': 'Paulo E Mattos, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "D'Or Institute for Research and Eduaction"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "D'Or Institute for Research and Education", 'class': 'OTHER'}, 'collaborators': [{'name': 'Okinawa Institute of Science and Technology Graduate University', 'class': 'OTHER'}, {'name': 'Federal University of Rio Grande do Sul', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}