Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-01-24 @ 3:39 AM
Study NCT ID:
NCT01961050
Status:
COMPLETED
Last Update Posted:
2016-02-19
First Post:
2013-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventing FAS/ARND in Russian Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063647', 'term': 'Fetal Alcohol Spectrum Disorders'}], 'ancestors': [{'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D020751', 'term': 'Alcohol-Induced Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 767}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-18', 'studyFirstSubmitDate': '2013-10-08', 'studyFirstSubmitQcDate': '2013-10-10', 'lastUpdatePostDateStruct': {'date': '2016-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 3 months', 'timeFrame': '3 months', 'description': 'Interviews are conducted at the baseline and follow-up assessments at 3, 6, and 12 months after the baseline to assess self-reported alcohol consumption, sexual activity, and contraception use to identify AEP risk.'}, {'measure': 'Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 6 months', 'timeFrame': '6 months', 'description': 'Interviews are conducted at the baseline and follow-up assessments at 3, 6, and 12 months after the baseline to assess self-reported alcohol consumption, sexual activity, and contraception use to identify AEP risk.'}, {'measure': 'Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 12 months', 'timeFrame': '12 months', 'description': 'Interviews are conducted at the baseline and follow-up assessments at 3, 6, and 12 months after the baseline to assess self-reported alcohol consumption, sexual activity, and contraception use to identify AEP risk.'}], 'secondaryOutcomes': [{'measure': 'Changes in alcohol consumption from baseline', 'timeFrame': '3 months, 6 months, and 12 months follow-up', 'description': 'Interviews assessed self-reported quantity/frequency of alcohol consumption and frequency of binge drinking and a detailed alcohol consumption report was received utilizing the Time Line Follow Back (TLFB) measure.'}, {'measure': 'Changes in knowledge about Fetal Alcohol Syndrome (FAS) from baseline', 'timeFrame': '3 months, 6 months, and 12 months follow-up', 'description': 'A survey measure assessed knowledge about FAS'}, {'measure': 'Changes in Health beliefs and attitudes from baseline', 'timeFrame': '3 months, 6 months, and 12 months follow-up', 'description': 'A survey measure assessed attitudes and health beliefs related to alcohol use during pregnancy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['alcohol', 'pregnancy', 'fetal exposure', 'prevention', 'FAS', 'Alcohol-Related Neurodevelopmental Disorder (ARND)'], 'conditions': ['Fetal Alcohol Syndrome (FAS)', 'Fetal Alcohol Spectrum Disorders', 'Alcohol Abuse in Pregnancy']}, 'referencesModule': {'references': [{'pmid': '23294846', 'type': 'RESULT', 'citation': "Balachova T, Bonner BL, Chaffin M, Isurina G, Shapkaitz V, Tsvetkova L, Volkova E, Grandilevskaya I, Skitnevskaya L, Knowlton N. Brief FASD prevention intervention: physicians' skills demonstrated in a clinical trial in Russia. Addict Sci Clin Pract. 2013 Jan 8;8(1):1. doi: 10.1186/1940-0640-8-1."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate an intervention aimed at reducing risk for alcohol-exposed pregnancies and preventing Fetal Alcohol Spectrum Disorders in Russian children. The study will determine whether physicians, trained in a dual-focused brief motivational intervention and monitored for performance, can foster greater change in knowledge, health beliefs, alcohol use, and alcohol-exposed pregnancy risk in Russian women who are at risk than standard care.', 'detailedDescription': "The study is a two-arm, 20-site, site-randomized, controlled trial testing an intervention to reduce risk for alcohol-exposed pregnancies in at-risk women (at-risk drinking childbearing age women who are heterosexually active, and not consistently using contraception). The trial will assess feasibility of a dual-focused (i.e. contraception use-drinking reduction) brief physician intervention (DFBPI) and determine whether physicians, trained in DFBPI and monitored for compliance, can foster greater reduction of women's risk behaviors compared to standard care. The intervention is specifically designed to be deliverable routinely by Obstetrics and Gynecology physicians(OB/GYN) to large numbers of women at women's clinics."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* nonpregnant women\n* childbearing age (between 18 and 44 years of age)\n* fertile\n* at risk for an alcohol-exposed pregnancy: drinking at-risk (4 or more drinks on one occasion or more than 7 drinks per week)in the last 3 months and report having unprotected intercourse at least once in the last 6 months\n\nExclusion Criteria:\n\n* unable comprehend interview questions'}, 'identificationModule': {'nctId': 'NCT01961050', 'briefTitle': 'Preventing FAS/ARND in Russian Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Preventing FAS/ARND in Russian Children', 'orgStudyIdInfo': {'id': 'R01AA016234_IRB 2758'}, 'secondaryIdInfos': [{'id': '5R01AA016234', 'link': 'https://reporter.nih.gov/quickSearch/5R01AA016234', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Dual-Focused Brief Physician Intervention (DFBPI)', 'interventionNames': ['Behavioral: Dual-Focused Brief Physician Intervention (DFBPI)']}, {'type': 'OTHER', 'label': 'Standard care', 'description': 'Services as usual including standard OB/GYN clinic visits; no experimental intervention is provided.', 'interventionNames': ['Other: Services as usual']}], 'interventions': [{'name': 'Dual-Focused Brief Physician Intervention (DFBPI)', 'type': 'BEHAVIORAL', 'description': 'The DFBPI is incorporated in OB/GYN clinic visit. The intervention consists of two brief (5 to 10 minutes) manualized counseling segments delivered face-to-face by an OB/GYN in the context of two clinic visits.', 'armGroupLabels': ['Intervention']}, {'name': 'Services as usual', 'type': 'OTHER', 'description': 'Active Comparator: Standard OB/GYN clinic visits that include OB/GYN services as usual.', 'armGroupLabels': ['Standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '603950', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': "Women's Clinics", 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '199034', 'city': 'Saint Peterburg', 'country': 'Russia', 'facility': "Women's clinics"}], 'overallOfficials': [{'name': 'Tatiana Balachova, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}, {'name': 'Fogarty International Center of the National Institute of Health', 'class': 'NIH'}, {'name': 'St. Petersburg State Pavlov Medical University', 'class': 'OTHER'}, {'name': 'Nizhny Novgorod State Pedagogical University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}