Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-03-06 @ 2:04 PM
Study NCT ID:
NCT06685003
Status:
RECRUITING
Last Update Posted:
2024-11-12
First Post:
2024-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II: Scalable Digital Delivery of CRAFT Training for Professionals to Maximize Treatment Rates of OUD in Families
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'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'], 'maskingDescription': 'The participants will know what group they are in. When data is sent to the statistician for analysis it will be coded in the groups (e.g., 123) without informing which is which. This masks (or blinds) him to the condition.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Conduct a fully randomized controlled trial of 3 levels of digital training (Level 1 - Digital tutorial only \\[T\\]; Level 2 - Tutorial \\& digital training materials for self-study \\[TM\\]; Level 3 - Tutorial, digital materials, feedback and coaching \\[TMC\\]) to examine the effects of training on CRAFT knowledge, fidelity, and treatment entry and retention.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-11', 'studyFirstSubmitDate': '2024-11-11', 'studyFirstSubmitQcDate': '2024-11-11', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'New Treatment Entry: Identified Patient Treatment Entry Status', 'timeFrame': '3 months, 6 months', 'description': "Participants report whether their client's loved one has attended any treatment for their opioid use problem since the baseline assessment by answering questions regarding participation in treatment. In addition, reports of treatment entry to WTV staff were categorized as treatment entry. The outcome is the proportion of participants reporting that their client's loved one (identified patient; IP) entered new treatment"}], 'primaryOutcomes': [{'measure': 'CRAFT Procedure Fidelity', 'timeFrame': '3 months, 6 months', 'description': 'CRAFT performance on the mock sessions observed by trained coders rating performance of each CRAFT treatment entry procedure (6 items), homework procedures (2 items), overall CRAFT approach (2 items), and general clinical skill (4 items) on a 5-point scale (i.e., 1 =poor; 3 =satisfactory; 5 =excellent). Total score will be calculated across all 14 items for each participant. Average scores on each procedure and in total will be calculated for each participant group at baseline and at follow-ups. Scores can range from 6 - 30 on treatment entry; 2 - 10 on homework and CRAFT approach; 4 - 20 on general clinical skill; and 14 - 70 on the overall total.'}], 'secondaryOutcomes': [{'measure': '3 months', 'timeFrame': '3 months, 6 months', 'description': 'Measuring the proficiency with which participants answer questions about the CRAFT approach.\n\nMeasuring the proficiency with which participants answer questions about the CRAFT approach.\n\nThe 20-item CRAFT Knowledge Test is scored by calculating the number of correct answers for each individual and then averaging scores across participants within each group (T, TM, TMC). Scores could range from 0 - 20.'}, {'measure': 'Program Implementation Potential Scale', 'timeFrame': '3 months, 6 months', 'description': 'Measured by program implementation potential questionnaire containing 25 Items; responses on 1-6 scale (strongly agree to strongly disagree).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Community Reinforcement And Family Training', 'Family Health', 'Substance-Related Disorders']}, 'descriptionModule': {'briefSummary': 'The goal of this project is to demonstrate digital training efficacy at scale and commercial readiness.\n\nThis pilot project will advance piloted digital training programs for CRAFT and maximize scalability. In this project, investigators will:\n\nAim 1: Optimize the digital CRAFT training product based on data and feedback from the pilot and commercialization advisors.\n\nAim 2: Conduct a fully powered randomized control trial of 3 levels of digital training (Level 1 - Digital tutorial only \\[T\\]; Level 2 - Tutorial \\& digital training materials for self-study \\[TM\\]; Level 3 - Tutorial, digital materials, feedback and coaching \\[TMC\\]) to examine the effects of training on CRAFT knowledge, fidelity, and plus IP treatment entry/retention and counselor skill pre- and post-tutorial, at 12 weeks and at 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be over 19\n* Live in the US\n* Work in a counselor-related profession\n* Have counseling work that involves clients\n* Work with CSOs impacted by OUD, or could work with this type of client\n* Have not been certified in CRAFT\n* Have not participated in the 2023 WTV counselor training pilot study\n* Be able to provide at least 45-minute individual counselor sessions to at least one CSO (CSO)\n* Be able and willing to complete intervention activities over the course of the 12-week study as determined by the random assignment including: participating in the tutorial and training and submitting the required session audiotapes\n* Report having access to a computer and smartphone with internet access, email, and word processing capability\n* Demonstrate complete understanding of the requirements for participation in the study by reading and signing the consent form and completing the online consent quiz or confirmation call\n* Provide valid locator information to allow research and CRAFT training staff to contact them to schedule study-related appointments\n* Complete the first assessment mock session with our standardized patient (SP) and pre-tutorial surveys\n\nExclusion Criteria:\n\n* Does not agree to participate\n* Does not complete the baseline assessment requirements\n* Is not English-speaking\n* Participated in the Qualitative Review aspect of the study'}, 'identificationModule': {'nctId': 'NCT06685003', 'briefTitle': 'Phase II: Scalable Digital Delivery of CRAFT Training for Professionals to Maximize Treatment Rates of OUD in Families', 'organization': {'class': 'OTHER', 'fullName': 'We The Village, Inc.'}, 'officialTitle': 'Phase II: Scalable Digital Delivery of Evidence-based Training for Addiction Professionals to Maximize Treatment Admission and Retention Rates of Opioid Use Disorder in Affected Families', 'orgStudyIdInfo': {'id': '2403'}, 'secondaryIdInfos': [{'id': '4R44DA053845-02', 'link': 'https://reporter.nih.gov/quickSearch/4R44DA053845-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'T - Digital Tutorial overview', 'description': 'A digital tutorial consisting of a curriculum dashboard for review of 20 modules, including videos, PDFs, text and quizzes, which are to be unlocked sequentially over seven weeks. Modules remain available during the 6-month study timeframe. Participants receive weekly contact encouraging engagement in all of the materials available to them.', 'interventionNames': ['Behavioral: Digital Tutorial overview']}, {'type': 'EXPERIMENTAL', 'label': 'TM - Digital Tutorial plus training Materials', 'description': 'Participants receive the digital tutorial (T), plus access to 15 additional in depth modules of digital training materials also released weekly alongside the tutorial modules. Modules remain available during the 6-month study timeframe. Participants receive weekly contact encouraging engagement in all of the materials available to them.', 'interventionNames': ['Behavioral: Digital Tutorial overview', 'Behavioral: Digital Tutorial plus training Materials']}, {'type': 'EXPERIMENTAL', 'label': 'TMC - Digital Tutorial plus training Materials plus feedback and Coaching', 'description': 'Participants receive the digital tutorial (T) plus the digital Training materials (TM), plus they submit audio recordings of sessions with clients and receive feedback on their application of CRAFT and receive group coaching on how to improve.', 'interventionNames': ['Behavioral: Digital Tutorial overview', 'Behavioral: Digital Tutorial plus training Materials', 'Behavioral: Digital Tutorial plus training Materials plus feedback and Coaching']}], 'interventions': [{'name': 'Digital Tutorial overview', 'type': 'BEHAVIORAL', 'otherNames': ['T'], 'description': 'Self study of a digital tutorial covering an overview of CRAFT designed to be reviewed within 7 weeks and revisited over 6 months.', 'armGroupLabels': ['T - Digital Tutorial overview', 'TM - Digital Tutorial plus training Materials', 'TMC - Digital Tutorial plus training Materials plus feedback and Coaching']}, {'name': 'Digital Tutorial plus training Materials', 'type': 'BEHAVIORAL', 'otherNames': ['TM'], 'description': 'Self study of a digital tutorial covering an overview of CRAFT and deeper materials designed to be reviewed within 7 weeks and revisited over 6 months.', 'armGroupLabels': ['TM - Digital Tutorial plus training Materials', 'TMC - Digital Tutorial plus training Materials plus feedback and Coaching']}, {'name': 'Digital Tutorial plus training Materials plus feedback and Coaching', 'type': 'BEHAVIORAL', 'otherNames': ['TMC'], 'description': 'Self study of a digital tutorial covering an overview of CRAFT and deeper materials designed to be reviewed within 7 weeks and revisited over 6 months. Plus group coaching and feedback on audio recordings of CRAFT procedures used in sessions', 'armGroupLabels': ['TMC - Digital Tutorial plus training Materials plus feedback and Coaching']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10281', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jane P Macky, MA', 'role': 'CONTACT', 'email': 'jane@wethevillage.co', 'phone': '917-684-4267'}, {'name': 'Calum J Handley, BA', 'role': 'CONTACT', 'email': 'calum@wethevillage.co', 'phone': '9176789160'}], 'facility': 'We The Village, Inc.', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Jane Macky, MA', 'role': 'CONTACT', 'email': 'jane@wethevillage.co', 'phone': '9176844267'}, {'name': 'Calum Handley', 'role': 'CONTACT', 'email': 'calum@wethevillage.co', 'phone': '4134384673'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'We The Village, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Public Health Management Corporation', 'class': 'OTHER'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}