Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2026-03-14 @ 6:19 AM
Study NCT ID:
NCT02973906
Status:
COMPLETED
Last Update Posted:
2021-05-07
First Post:
2015-05-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Web, Group, and Telehealth Formats of a Military Parenting Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-04', 'size': 663004, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-07-16T15:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 244}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-06', 'studyFirstSubmitDate': '2015-05-04', 'studyFirstSubmitQcDate': '2016-11-25', 'lastUpdatePostDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in parenting practices and parent/child interactions', 'timeFrame': 'Change from Baseline, 6 months, 12 months, 24 months', 'description': 'Observed parenting is coded using FIT (Family Interaction Task) and self-report of parenting using the APQ (Alabama parenting Questionnaire),'}], 'secondaryOutcomes': [{'measure': 'Change in child adjustment and substance use', 'timeFrame': 'Change from Baseline, 6 months, 12 months, 24 months', 'description': 'Child adjustment assessed using BASC-2 (teacher, parent, and child self-report); Child intentions and use of substances assess using the Alcohol Use Intentions and Behavior Scale; Child distress measured by CDI (Children\'s Depression Inventory); Child peer adjustment is measured by 16-item scale assessing loneliness and dissatisfaction with peer relations; Deviant peer association measured using "Describing Friends"'}, {'measure': 'Change in parenting stress and support', 'timeFrame': 'Change from Baseline, 6 months, 12 months, 24 months', 'description': 'Parenting Stress Index-Short Form'}, {'measure': 'Participant report of satisfaction with intervention', 'timeFrame': 'Change from Baseline, 6 months, 12 months, 24 months', 'description': 'Two 10-item measures: (1) group satisfaction and (2) online satisfaction'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Parenting']}, 'descriptionModule': {'briefSummary': 'The overarching goal of this study is to advance research on family-based prevention of negative child outcomes for reintegrating Operation Enduring Freedom/Operation Iraqi Freedom personnel by evaluating different formats of a parenting program, After Deployment, Adaptive Parenting Tools (ADAPT). The ADAPT program is based upon the Parent Management Training-Oregon Model/PMTO, but adapted for military deployed families. The PI will examine which of three delivery formats of ADAPT is most effective at reducing youth risk behaviors associated with negative childhood outcomes by improving parenting, child, and parent adjustment. There is a clear intent to benefit all subjects in this study (except surveyed teachers), including children.', 'detailedDescription': 'The overarching goal of this study is to advance research on family-based prevention of negative child outcomes for reintegrating Operation Enduring Freedom/Operation Iraqi Freedom personnel by evaluating different formats of a parenting program, After Deployment, Adaptive Parenting Tools (ADAPT). The ADAPT program is based upon the Parent Management Training-Oregon Model/PMTO, but adapted for military deployed families. The investigators will examine which of three delivery formats of ADAPT is most effective at reducing youth risk behaviors associated with negative childhood outcomes by improving parenting, child, and parent adjustment. There is a clear intent to benefit all subjects in this study (except surveyed teachers), including children.\n\nCombat deployment and related challenges are family stressors, associated with more negative parent-child interactions, ineffective and coercive parenting practices and lower levels of parenting satisfaction. Disrupted parenting practices are well-known predictors of risk for child adjustment difficulties that are precursors to youth substance use, including behavior problems, school failure, deviant peer association, and depression . These child adjustment problems can contribute to continuing parental stress, increasing parental distress, and further disrupting parenting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria are:\n\n* one parent has returned from deployment to OIF or OEF\n* at least one child ages 5-12 in their custody and living with parent(s) in the home\n* high speed internet access at home We will include both single-and two-parent families, as well as families where care is shared between non-partnered adults (e.g. grandparent and mother)\n\nExclusion Criteria:\n\n* active psychosis\n* an open child protection case for abuse or neglect in the family\n* a serious child mental health diagnosis\n* families who piloted material or participated in or are currently participating in the original ADAPT RCT.'}, 'identificationModule': {'nctId': 'NCT02973906', 'briefTitle': 'Comparing Web, Group, and Telehealth Formats of a Military Parenting Program', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Comparing Web, Group, and Telehealth Formats of a Military Parenting Program', 'orgStudyIdInfo': {'id': '1407S52001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ADAPT Self Directed web', 'description': 'ADAPT Self Directed Web. In the self-directed web-only ADAPT condition, participants have access to the full ADAPT website (10 modules, online discussion forum)', 'interventionNames': ['Other: ADAPT Self Directed web']}, {'type': 'OTHER', 'label': 'ADAPT individualized web-facilitated', 'description': 'This condition comprises access to the full ADAPT web program with augmentation of individual facilitator web support (i.e. the facilitator connects via Google Hangout). Facilitators meet with families at a mutually convenient time weekly (10-14 weeks, approximately 3 sessions per month).', 'interventionNames': ['Other: ADAPT individualized web-facilitated']}, {'type': 'OTHER', 'label': 'Group-based ADAPT', 'description': 'Groups will meet weekly for 120 minutes, at a time convenient to participants (usually early evening). Groups cover core ADAPT/PMTO topics', 'interventionNames': ['Other: Group-based ADAPT']}], 'interventions': [{'name': 'ADAPT Self Directed web', 'type': 'OTHER', 'description': 'In the self-directed web-only ADAPT condition, participants have access to the full ADAPT website (10 modules, online discussion forum', 'armGroupLabels': ['ADAPT Self Directed web']}, {'name': 'ADAPT individualized web-facilitated', 'type': 'OTHER', 'description': 'This condition comprises access to the full ADAPT web program as described above, with augmentation of individual facilitator web support (i.e. the facilitator connects via Google Hangout). Facilitators meet with families at a mutually convenient time weekly (10-14 weeks, approximately 3 sessions per month).', 'armGroupLabels': ['ADAPT individualized web-facilitated']}, {'name': 'Group-based ADAPT', 'type': 'OTHER', 'description': 'Groups will meet weekly for 120 minutes, at a time convenient to participants (usually early evening). Groups cover core ADAPT/PMTO topics:', 'armGroupLabels': ['Group-based ADAPT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55415', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': "Institute for Translational Research in Children's Mental Health", 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Abigail Gweitrz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Institute for Translational Research in Children's Mental Health University of Minnesota"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}