Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-01-07 @ 4:40 PM
Study NCT ID:
NCT03045159
Status:
UNKNOWN
Last Update Posted:
2017-02-07
First Post:
2016-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strong Families Strong Forces: Supporting Active Duty Families With Very Young Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'outcomes assessor blinded to study condition'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-03', 'studyFirstSubmitDate': '2016-03-31', 'studyFirstSubmitQcDate': '2017-02-03', 'lastUpdatePostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parenting Stress Index (PSI)', 'timeFrame': 'Change from baseline to 24 months', 'description': 'Assesses parenting stress in three domains: parental distress, parent-child dysfunctional interaction, and difficult child.'}], 'secondaryOutcomes': [{'measure': 'Coparenting Scale', 'timeFrame': 'Change from baseline to 24 months', 'description': "Assesses parents' perception of their own coparenting behavior."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['deployment cycle', 'military family', 'prevention', 'stress', 'military child', 'parenting', 'coparenting'], 'conditions': ['Deployment']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to evaluate the efficacy of the Strong Families Strong Forces Parenting Program compared to a parental self-care (Strong Parents) condition in a sample of 150 Active Duty Families with children ages birth to 5 years.', 'detailedDescription': 'The overall aim of this research is to adapt and evaluate the efficacy of a parenting program compared to a parental self-care program for Active Duty families. A sample of 150 Active Duty families with young children who have a parent scheduled to deploy in the next six months will be recruited to participate. Families will be assigned either to receive the Strong Families Strong Forces Parenting Program, designed to reduce the impact of deployment separation on parenting stress and co-parenting, or to the Strong Parents Self-Care program, designed to support parents to focus on the importance of self-care throughout the deployment cycle. Investigators will compare the two groups on parenting stress, quality of parent-child relationships, parenting/co-parenting, and family and child well-being.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cohabitating couple with at least one child age birth to 5 years old in which one parent is active duty and is scheduled to deploy within the next 6 months\n* Anticipated deployment time must be at least six months and excludes separations due to the Service Member attending a school\n* Anticipate that non-deploying parent will remain in the area during the deployment\n* Both parents are willing to consent to study participation\n* DEERS -eligible\n* 18 years or older\n* English-speaking\n* The parent remaining at home to care for the children anticipates remaining within 30 miles of Fort Hood to be seen in home, otherwise will need to be seen in office\n* Anticipate that both parents will remain in the area for at least three months after redeployment to complete intervention and follow-up assessment\n\nExclusion Criteria:\n\n* Any family member with a significant medical or psychiatric condition requiring a higher level of care than can be provided by the study/comparison protocols\n* Active psychosis or mania'}, 'identificationModule': {'nctId': 'NCT03045159', 'briefTitle': 'Strong Families Strong Forces: Supporting Active Duty Families With Very Young Children', 'organization': {'class': 'OTHER', 'fullName': 'Boston University'}, 'officialTitle': 'Supporting Military Families With Young Children Throughout the Deployment Lifecycle', 'orgStudyIdInfo': {'id': 'W81XWH-14-2-0123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Strong Families', 'description': 'parenting program', 'interventionNames': ['Behavioral: Strong Families Strong Forces']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Strong Parents', 'description': 'self-care program', 'interventionNames': ['Behavioral: Strong Parents']}], 'interventions': [{'name': 'Strong Families Strong Forces', 'type': 'BEHAVIORAL', 'description': 'Parenting program', 'armGroupLabels': ['Strong Families']}, {'name': 'Strong Parents', 'type': 'BEHAVIORAL', 'description': 'self-care program', 'armGroupLabels': ['Strong Parents']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76544', 'city': 'Fort Hood', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katherine Dondanville, PsyD', 'role': 'CONTACT', 'phone': '254-288-1474'}, {'name': 'Trenton James', 'role': 'CONTACT', 'phone': '(254) 288-2147'}], 'facility': 'STRONG STAR Research Consortium', 'geoPoint': {'lat': 31.25483, 'lon': -97.70913}}], 'centralContacts': [{'name': 'Kathering Dondanville, PsyD', 'role': 'CONTACT', 'phone': '(254) 288-1474'}, {'name': 'Trenton James, MAJ', 'role': 'CONTACT', 'phone': '(254) 288-2147'}], 'overallOfficials': [{'name': 'Ellen DeVoe, Ph. D. LICSW', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, {'name': 'RAND', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}