[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06661031":3,"trial-entities:NCT06661031":167,"trial-summary:NCT06661031":170},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":44,"secondary_outcomes":87,"sex":119,"minimum_age":120,"maximum_age":121,"healthy_volunteers":14,"eligibility_criteria":122,"std_ages":142,"locations":144,"central_contacts":153,"overall_officials":154,"references":155,"see_also_links":166},"NCT06661031","IRB-P00049240","Developing a Telehealth + mHealth Cannabis Use Intervention for Young Adults","ENROLLING_BY_INVITATION","2027-05","2025-12","2026-08-03","2024-12-10","Boston Children's Hospital","OTHER",false,"The goal of this clinical trial is to determine 1) feasibility of the MOMENT-V intervention for cannabis use disorder in young adults, 2) feasibility of conducting the trial remotely, and 3) whether the MOMENT-V intervention reduces cannabis use frequency and problems. Researchers will compare the MOMENT-V intervention to usual care enhanced by a counselor meeting.\n\nParticipants will either meet with a counselor two times and use an app on their phone for two weeks, or meet with a counselor briefly one time. All participants will be asked to complete electronic surveys, interviews with a research assistant, and saliva drug testing at home over three months.",null,[18],"Cannabis Use Disorder",[20,21,22],"cannabis use","behavioral intervention","young adult","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},65,"ESTIMATED",[31,39],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":37},"BEHAVIORAL","Motivational Enhancement Therapy plus Ecological Momentary Intervention","Two Motivational Enhancement Therapy (MET) sessions (1st, \\~45 minutes; 2nd, \\~30 minutes) between counselor and participant occur one week apart. MET sessions are personalized, interactive, face-to-face, and delivered according to a manual. MET session discussion topics include triggers for cannabis use, life goals\u002Fvalues, and development of a change plan. Participants then complete a 2-week Ecological Momentary Intervention (EMI) period. Survey prompts are sent 4x\u002Fday (3x\u002Fday at quasi-randomized times, 1x\u002Fday at fixed time; \\~2 mins each) that ask about the participant's recent cannabis use. Depending on answers reported, the participant can receive tailored messages that support their self-efficacy and prompt use of coping strategies.",[36],"Intervention arm",[38],"MOMENT-V",{"type":32,"name":40,"description":41,"armGroupLabels":42},"Enhanced Usual Care","Participants meet with a study counselor 1-on-1 via videoconference to review a brochure containing cannabis information and treatment resources.",[43],"Enhanced Usual Care arm",[45,49,53,57,61,65,68,72,76,80,83],{"measure":46,"description":47,"timeFrame":48},"Intervention completion","\\[Aim 1\\] Percent of participants assigned to the intervention arm completing the intervention (defined as both MET sessions and any EMI surveys). Benchmark: ≥80%","At week 3 (Upon completion of 2-week EMI period)",{"measure":50,"description":51,"timeFrame":52},"EMI engagement","\\[Aim 1\\] Percent of days on which participant responded to at least one survey during the 14 days of EMI. Benchmark: Median of ≥80% across intervention participants","In weeks 1-3 (during 2-week EMI period)",{"measure":54,"description":55,"timeFrame":56},"Acceptability: Overall satisfaction","\\[Aim 1\\] Satisfaction with intervention measured on the Client Satisfaction Questionnaire-8, an 8-item 4-point scale on which scores range from 8-32, with higher scores indicating greater satisfaction.\n\nBenchmark: ≥80% of participants with a scale score ≥24 (mean item score of ≥3 out 4)","At 6-month timepoint",{"measure":58,"description":59,"timeFrame":60},"Acceptability: Components","\\[Aim 1\\] Measure of acceptability (usability, likability, perceived effect, burden) for each intervention component (2 MET sessions and EMI). Components assessed with an 11- or 12-item 5-point Likert-type scales (1, Strongly Disagree to 5, Strongly Agree) developed for the study. Higher scores indicate greater acceptability.\n\nBenchmark for each scale: ≥80% of participants with mean item score ≥4 out of 5","At week 0, week 1, and week 3",{"measure":62,"description":63,"timeFrame":64},"Screening","\\[Aim 2\\] Number of patients self-screening per month. Benchmark: ≥13 per month","During recruitment (upon completion of eligibility survey: pre-enrollment, pre-Baseline)",{"measure":66,"description":67,"timeFrame":64},"Eligibility","\\[Aim 2\\] Number of patients eligible per month. Benchmark: ≥6 per month",{"measure":69,"description":70,"timeFrame":71},"Enrollment","\\[Aim 2\\] Number of patients enrolled per month. Benchmark: ≥3 per month","Upon enrollment",{"measure":73,"description":74,"timeFrame":75},"Retention in trial","\\[Aim 2\\] Percent of participants retained at each assessment time point (3 weeks, 3 months, 6 months, by assigned condition.\n\nBenchmark: ≥80% at each time point","At 3-week timepoint, 3-month timepoint, 6-month timepoint",{"measure":77,"description":78,"timeFrame":79},"Days of cannabis use","\\[Aim 3\\] Number of cannabis use days measured on Timeline Follow-Back (TLFB) calendar","At Baseline, 3-week timepoint, 3-month timepoint, 6-month timepoint",{"measure":81,"description":82,"timeFrame":79},"Times of cannabis use","\\[Aim 3\\] Number of cannabis use times measured on TLFB calendar",{"measure":84,"description":85,"timeFrame":86},"Negative consequences of cannabis use","\\[Aim 3\\] Number of negative consequences (problems) measured on the 19-item Marijuana Problems Scale","At Baseline, 3-month timepoint, 6-month timepoint",[88,92,96,100,103,106,110,113,116],{"measure":89,"description":90,"timeFrame":91},"Therapeutic alliance","\\[Aim 1\\] Working Alliance Inventory - Short Form, 12-items, 5-point Likert-type scale, total scale score and subscale scores (affective bond, perceived agreement on tasks, perceived agreement on goals; 4 items each), participant (\"client\") and observer versions reported separately and tested for agreement.\n\nBenchmark: ≥80% of participants with total score ≥48 (mean item score ≥4), participant version","At week 1",{"measure":93,"description":94,"timeFrame":95},"MET counselor adherence to MI principles","\\[Aim 1\\] Measure of counselor adherence to MI principles in each MET session, as reported by participant. Sessions assessed with 7- to 9-item 5-point Likert-type scales (Strongly Disagree to Strongly Agree) developed for the study.\n\nBenchmark for each scale: ≥80% of participants with mean item score ≥4 out of 5","At week 0 and week 1",{"measure":97,"description":98,"timeFrame":99},"Duration of study activities","\\[Aim 2\\] Duration of each study activity (in minutes)","All timepoints, upon completion of each timepoint (Baseline, week 0, week 1, weeks 1-3 [two-week EMI period], 3-weeks, 3-months, 6-months)",{"measure":101,"description":102,"timeFrame":86},"Cannabis use disorder (CUD) symptoms","\\[Aim 3\\] Symptom count measured by the Composite International Diagnostic Interview - Substance Abuse Module (CIDI-SAM)",{"measure":104,"description":105,"timeFrame":79},"Amount of THC used","\\[Aim 3\\] Number of standard THC units (1 unit = 5 mg THC) derived from number of familiar units (joints, vapes, gummies, etc.) x amount per unit (grams, milligrams, or milliliters) x estimated potency (% THC), measured on TLFB calendar.\n\nIf unable to calculate standard THC units: Number of familiar units (joints, vapes, gummies, etc.)",{"measure":107,"description":108,"timeFrame":109},"Motivation to change cannabis use","\\[Aim 3\\] One item each assessing readiness to, importance of, and confidence to change cannabis use, developed and used in our prior research, 11-point Likert-type scale for each. On follow-up, modified items about maintaining behavior if participant reports having started to change behavior but not having achieved change goals, or having changed behavior and achieved goals.","At Baseline, week 0, week 1, 3-months, 6-months",{"measure":111,"description":112,"timeFrame":86},"Psychological distress","\\[Aim 3\\] Kessler Psychological Scale-6 (K6), assessing frequency of experiencing 6 symptoms in the past month on a 5-point Likert-type scale, with coding such that high scores indicate greater psychological distress.",{"measure":114,"description":115,"timeFrame":86},"Cognitive function","\\[Aim 3\\] PROMIS Cognitive Function v.2.0 - Short Form 6a, 6 items, 5-point Likert-type response, measures participant-perceived cognitive deficits in the past 7 days. Age- and gender-weighted T scores, higher T-scores indicating better cognitive function.",{"measure":117,"description":118,"timeFrame":86},"Quality of life","\\[Aim 3\\] PROMIS Global Health v1.2, a 10-item, 5-point Likert-type response (except pain item 0-10), participant-reported measure of physical, mental, and social health, in general except for past 7 days for emotional problems, fatigue, and pain. Age- and gender-weighted T scores, higher T-scores indicating better quality of life.","ALL","18 Years","26 Years",{"inclusion":123,"exclusion":135,"raw_text":141},[124,125,126,127,128,129,130,131,132,133,134],"Primary care patient of the Boston Children's Hospital Adolescent\u002FYoung Adult Medicine Practice","Participation in MOMENT-V open pilot","Ownership of a smartphone","Availability for the 2-week study duration","Primary care patient of the Boston Children's Hospital Adolescent\u002FYoung Adult Medicine Practice or Martha Eliot Health Center Adolescent Clinic","18 to 26 years old","Cannabis Use Disorders Identification Test-Revised (CUDIT-R) score of ≥8","Recreational cannabis use on \\>3 days\u002Fweek, on average, in the past 30 days","Ownership of a smartphone that is PIN- or password-protected","Ability to read and speak English","Availability for the 6-month study duration",[136,137,136,138,139,137,140],"Inability\u002FUnwillingness to provide contact information","Current pregnancy or parenting","Written certification from a physician for marijuana for medical use","Current participation in a substance use treatment program or research study","Participation in prior MOMENT or MOMENT-V research","For the oral fluid testing pilot\n\nInclusion Criteria:\n\n* Primary care patient of the Boston Children's Hospital Adolescent\u002FYoung Adult Medicine Practice\n* Participation in MOMENT-V open pilot\n* Ownership of a smartphone\n* Availability for the 2-week study duration\n\nExclusion Criteria:\n\n* Inability\u002FUnwillingness to provide contact information\n* Current pregnancy or parenting\n\nFor the pilot RCT\n\nInclusion Criteria:\n\n* Primary care patient of the Boston Children's Hospital Adolescent\u002FYoung Adult Medicine Practice or Martha Eliot Health Center Adolescent Clinic\n* 18 to 26 years old\n* Cannabis Use Disorders Identification Test-Revised (CUDIT-R) score of ≥8\n* Recreational cannabis use on \\>3 days\u002Fweek, on average, in the past 30 days\n* Ownership of a smartphone that is PIN- or password-protected\n* Ability to read and speak English\n* Availability for the 6-month study duration\n\nExclusion Criteria:\n\n* Inability\u002FUnwillingness to provide contact information\n* Written certification from a physician for marijuana for medical use\n* Current participation in a substance use treatment program or research study\n* Current pregnancy or parenting\n* Participation in prior MOMENT or MOMENT-V research",[143],"ADULT",[145],{"facility":12,"city":146,"state":147,"zip":148,"country":149,"geoPoint":150},"Boston","Massachusetts","02115","United States",{"lat":151,"lon":152},42.35843,-71.05977,[],[],[156,160,163],{"pmid":157,"type":158,"citation":159},"24139665","BACKGROUND","Shrier LA, Rhoads A, Burke P, Walls C, Blood EA. Real-time, contextual intervention using mobile technology to reduce marijuana use among youth: a pilot study. Addict Behav. 2014 Jan;39(1):173-80. doi: 10.1016\u002Fj.addbeh.2013.09.028. Epub 2013 Oct 4.",{"pmid":161,"type":158,"citation":162},"30148142","Shrier LA, Burke PJ, Kells M, Scherer EA, Sarda V, Jonestrask C, Xuan Z, Harris SK. Pilot randomized trial of MOMENT, a motivational counseling-plus-ecological momentary intervention to reduce marijuana use in youth. Mhealth. 2018 Jul 30;4:29. doi: 10.21037\u002Fmhealth.2018.07.04. eCollection 2018.",{"pmid":164,"type":158,"citation":165},"39111371","Shrier LA, McCaskill NH, Smith MC, O'Connell MM, Gluskin BS, Parker S, Everett V, Burke PJ, Harris SK. Telehealth counseling plus mHealth intervention for cannabis use in emerging adults: Development and a remote open pilot trial. J Subst Use Addict Treat. 2024 Nov;166:209472. doi: 10.1016\u002Fj.josat.2024.209472. Epub 2024 Aug 5.",[],{"nct_id":4,"conditions":168,"biomarkers":169},[18],[],{"nct_id":4,"found":14,"summary":16,"prompt_version":16}]