[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561504":3},{"organization":4,"armGroups":7,"interventions":46,"overallOfficials":52,"centralContacts":65,"locations":52,"responsibleParty":71,"collaborators":52,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":52,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":52,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":52,"overallStatus":95,"whyStopped":52,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":52},{"fullName":5,"class":6},"The National Center on Addiction and Substance Abuse at Columbia University","OTHER",[8,14,20,25,29,34,38,42],{"label":9,"type":10,"description":11,"interventionNames":12},"SH Only","ACTIVE_COMPARATOR","Participants receive standard helpline component only",[13],"Behavioral: Standard Helpline (SH)",{"label":15,"type":16,"description":17,"interventionNames":18},"SH+CST","EXPERIMENTAL","Participants receive the standard helpline component and the cognitive coping skills component.",[13,19],"Behavioral: Coping Skills Training (CST)",{"label":21,"type":16,"description":22,"interventionNames":23},"SH+ATM","Participants receive the standard helpline component and the automated messaging component.",[13,24],"Behavioral: Automated Text Messaging (ATM)",{"label":26,"type":16,"description":27,"interventionNames":28},"SH+CST+ATM","Participants receive the standard helpline component, the cognitive coping skills component, and the automated messaging component.",[13,19,24],{"label":30,"type":16,"description":31,"interventionNames":32},"SH+MI","Participants receive the standard helpline component and the motivational interviewing component.",[13,33],"Behavioral: Motivational Interviewing (MI)",{"label":35,"type":16,"description":36,"interventionNames":37},"SH+MI+CST","Participants receive the standard helpline component, the motivational interviewing component, and the cognitive coping skills component.",[13,33,19],{"label":39,"type":16,"description":40,"interventionNames":41},"SH+MI+ATM","Participants receive the standard helpline component, the motivational interviewing component, and the automated messaging component.",[13,33,24],{"label":43,"type":16,"description":44,"interventionNames":45},"SH+MI+CST+ATM","Participants receive the standard helpline component, the motivational interviewing component, the coping skills component, and the automated messaging component.",[13,33,19,24],[47,53,57,61],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"BEHAVIORAL","Standard Helpline (SH)","One digital helpline session that includes assessment, psychoeducation, and links to resources. Participants are also offered ongoing asynchronous digital support from the helpline.",[9,21,15,26,30,39,35,43],null,{"type":48,"name":54,"description":55,"armGroupLabels":56,"otherNames":52},"Motivational Interviewing (MI)","One digital helpline session that includes a structured motivational interviewing brief intervention.",[30,39,35,43],{"type":48,"name":58,"description":59,"armGroupLabels":60,"otherNames":52},"Coping Skills Training (CST)","One digital helpline session that includes a structured cognitive coping skills brief intervention.",[15,26,35,43],{"type":48,"name":62,"description":63,"armGroupLabels":64,"otherNames":52},"Automated Text Messaging (ATM)","Automated text messages are sent daily for 4 weeks.",[21,26,39,43],[66],{"name":67,"role":68,"phone":69,"phoneExt":52,"email":70},"Sarah Dauber, PhD","CONTACT","212-841-5270","sdauber@toendaddiction.org",{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":52,"oldOrganization":52},"PRINCIPAL_INVESTIGATOR","Sarah Dauber","Vice President","100561504","phase-1-helpline-pilot-factorial-trial-100561504",false,"NCT06591026","Helpline Pilot Factorial Trial","Helpline Delivery of Brief Interventions for Postpartum Heavy Episodic Drinking","Inclusion Criteria:\n\n* Resides full-time in the United States\n* Age 18-45 years\n* Gave birth to an infant within the prior 4 weeks\n* Speaks and reads English\n* Owns a text-enabled cell-phone\n* Receives a score of 2 or more on the T-ACE alcohol risk screener\n* Reports ONE of the following: (a) drinking weekly or more often in the prior month; or (b) having 4 or more standard drinks at one time at least monthly in the 12 months prior to becoming pregnant.\n\nExclusion Criteria:\n\n* Resides outside of the United States\n* Age under 18 years or over 45 years\n* Did not give birth to an infant within the prior 4 weeks\n* Cannot speak and read English\n* Does not own a text-enabled cell-phone\n* Does not receive a score of at least 2 on the T-ACE alcohol risk screener\n* Does not report either drinking weekly or more often in the past month or having 4 or more standard drinks at least monthly in the 12 months prior to becoming pregnant\n* Scores greater than 4 on the AUDIT-C, indicating an alcohol use disorder",true,"FEMALE","18 Years","45 Years",{"count":87,"type":88},120,"ESTIMATED","INTERVENTIONAL",[91],"PHASE1","The pilot factorial trial will (1) evaluate feasibility, acceptability, and fidelity of the intervention components (Aim 2.1), and (2) collect proof-of-concept data on the impact of the components on the proximal (motivation, self-efficacy, and self-regulation) and distal (quantity and frequency of HED) outcomes (Aim 2.2). Participants will include 120 postpartum mothers recruited from social media. The investigators will conduct a pilot 2X2X2 balanced full factorial trial, with 4 factors (1 constant, 3 randomized to 2 levels each) and 8 study conditions. The 4 factors will include: (1) Standard Helpline (constant); (2) Motivational Interviewing (yes vs. no); (3) Coping skills training (yes vs. no); (4) Automated messaging (yes vs. no). Participants will be randomly assigned to one of 8 study conditions, which will determine which combination of intervention components participants receive.",[94],"Heavy Drinking","NOT_YET_RECRUITING","2025-01-14",{"date":98,"type":99},"2025-01-15","ACTUAL",{"date":101,"type":88},"2025-12-01",{"date":103,"type":88},"2027-07-31",{"name":5,"class":6}]