Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 11:39 PM
Study NCT ID:
NCT04018560
Status:
COMPLETED
Last Update Posted:
2021-05-05
First Post:
2019-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensive Referral to Al-Anon: Benefits to Concerned Others and Their Drinkers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 402}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-04', 'studyFirstSubmitDate': '2019-07-08', 'studyFirstSubmitQcDate': '2019-07-11', 'lastUpdatePostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mental Health', 'timeFrame': 'The outcome measure will be assessed up to 1 year follow-up.', 'description': 'Items are rated on a 5-point scale (0=never, 4=very often). Mental Health is the mean of 10 items (e.g., How often have you experienced feeling hopeful); negative symptoms (e.g., anxious) are reverse scored.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Use Disorder']}, 'referencesModule': {'references': [{'pmid': '37219032', 'type': 'DERIVED', 'citation': "Timko C, Cucciare MA, Lor MC, Stein M, Vest N. Patient-Concerned Other Dyads' 12-Step Involvement and Patients' Substance Use: A Latent Class Growth Model Analysis. J Stud Alcohol Drugs. 2023 Sep;84(5):762-771. doi: 10.15288/jsad.22-00378. Epub 2023 May 18."}, {'pmid': '34427006', 'type': 'DERIVED', 'citation': "Timko C, Grant KM, Han X, Young LB, Cucciare MA. Al-Anon Intensive Referral to facilitate concerned others' participation in Al-Anon Family Groups: a randomized controlled trial. Addiction. 2022 Mar;117(3):590-599. doi: 10.1111/add.15670. Epub 2021 Oct 3."}]}, 'descriptionModule': {'briefSummary': 'This study is examining the effectiveness of Al-Anon Intensive Referral (AIR) with Concerned Others (COs) of individuals in treatment for alcohol use disorders ("drinkers"). AIR\'s goal is to facilitate Al-Anon participation and positive outcomes among COs.', 'detailedDescription': "In a randomized controlled trial, this 4-year project is evaluating AIR's effectiveness for COs. COs and their drinkers are assessed at baseline and 3-month, 6-month, and 1-year follow-ups. Hypotheses are that, compared to usual care, AIR will increase Al-Anon participation and improve CO outcomes. We will examine hypotheses using generalized mixed-effects regression models (GLMM). This project is built on the foundation that it is essential to help COs because of their own suffering."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. the drinker is an adult (≥19 years old) entering a treatment episode for the primary substance of alcohol;\n2. the drinker signs a release for researchers to contact a CO (also an adult) he or she identifies as a family member or close friend who has had contact with the drinker on at least 12 (40%) of the past 30 days; and\n3. the drinker and CO can communicate in English. -\n\nExclusion Criteria:\n\n1. the drinker is \\<19 years old, not entering a treatment episode for alcohol use disorder;\n2. the drinker does not sign a release for researchers to contact a CO;\n3. the drinker and CO cannot communicate in English. -'}, 'identificationModule': {'nctId': 'NCT04018560', 'briefTitle': 'Intensive Referral to Al-Anon: Benefits to Concerned Others and Their Drinkers', 'organization': {'class': 'OTHER', 'fullName': 'Palo Alto Veterans Institute for Research'}, 'officialTitle': 'Intensive Referral to Al-Anon: Benefits to Concerned Others and Their Drinkers', 'orgStudyIdInfo': {'id': 'TIM0026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'interventionNames': ['Behavioral: Al-Anon Intensive Referral (AIR)']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care'}], 'interventions': [{'name': 'Al-Anon Intensive Referral (AIR)', 'type': 'BEHAVIORAL', 'description': 'AIR is intended to facilitate Al-Anon participation.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'VA Palo Alto Health Care System', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Palo Alto Veterans Institute for Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christine Timko', 'investigatorAffiliation': 'Palo Alto Veterans Institute for Research'}}}}