[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06556433":3,"trial-entities:NCT06556433":116,"trial-summary:NCT06556433":119},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":39,"secondary_outcomes":44,"sex":45,"minimum_age":46,"maximum_age":47,"healthy_volunteers":15,"eligibility_criteria":48,"std_ages":69,"locations":72,"central_contacts":92,"overall_officials":101,"references":104,"see_also_links":115},"NCT06556433","2024-04-015","Family-Based Financial Incentives Intervention for Smoking Cessation","Alaska Native Family-Based, Financial Incentives Intervention for Smoking Cessation: An RCT","RECRUITING","2028-04-30","2026-08","2026-08-10","2024-09-03","Mayo Clinic","OTHER",false,"The current study will conduct an RCT to evaluate the effectiveness of a family-based incentive intervention with Alaska Native\u002FAmerican Indian families. The experimental arm will be compared to a control arm on biochemically-confirmed smoking abstinence at 6- and 12-months post-intervention.","Dyads will be stratified by the index participant's sex, and residence with family member, and by the family member's current smoking status then randomized to a no incentives control condition (n=328 dyads) or a 6-month incentive intervention (n=328 dyads).\n\nAll dyads will receive existing evidence-based cessation materials on treatment resources and social support strategies. The study will measure the index participant's smoking status in both study groups weekly during the first four weeks, and at three and six months. All participants, including support persons, will receive incentives when they complete each of the smoking status assessments. The intervention group will additionally receive individual rewards provided to the index participant for achieving verified smoking abstinence at each time point, to a maximum of $750.\n\nThe enrolled family member will also receive rewards equivalent to the value earned by the index participant that can contribute to family needs. The study will explore potential moderators (e.g., family member smoking status, index participant's sex) and mediators (e.g., interdependence) of intervention effects.",[19],"Smoking Cessation",[21,22,23,19,24],"Alaska Native","Family","Financial Incentive","Contingency Management","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},1312,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"BEHAVIORAL","Financial Incentive Rewards","Participants in the Rewards Group will have abstinence reinforced through escalating financial incentives.",[38],"Rewards Group",[40],{"measure":41,"description":42,"timeFrame":43},"Change in smoking status","Number of participants to have biochemically verified, prolonged smoking abstinence.","6 months, 12 months",[],"ALL","18 Years",null,{"inclusion":49,"exclusion":64,"raw_text":68},[50,51,52,53,54,55,56,57,58,59,51,60,61,62,63],"Alaska Native\u002FAmerican Indian (ANAI) person (based on self-reported race) and reside in Alaska.","Age ≥18 years.","Self-report smoking in the past 7 days, biochemically verified with saliva cotinine ≥ 30 ng\u002FmL (positive result based on at-home saliva swab test provided by study team).","Smoked ≥ 3 cigarettes per day over the past 3 months.","Considering or willing to make a quit attempt.","Have or will nominate one adult family member to enroll with them.","Own or have access to a mobile phone or tablet with Internet and text messaging capabilities, or will be loaned an iPad for the study duration","Willing to upload photos of self during completion of smoking status tests.","Willing to complete and sign an Internal Revenue Service (IRS) W-9 tax identification form if they wish to receive payments on the study.","Willing to provide written informed consent and participate in study-related tests and procedures.","Defined as family and nominated by the index participant, or have an ANAI family member who is ≥18 years and smokes that they would like to support in quitting.","Own or have access to a mobile phone or tablet with Internet and text messaging capabilities, or will be loaned an iPad for the study duration.","Willing to complete and sign an IRS W-9 tax identification form if they wish to receive payments on the study.","Willing to provide written informed consent and participate in study related tests and procedures.",[65,66,67,66],"Already enrolled in the study with another family member.","Participated in a prior study phase.","Already enrolled with another family member.","Index Participant Inclusion Criteria:\n\n* Alaska Native\u002FAmerican Indian (ANAI) person (based on self-reported race) and reside in Alaska.\n* Age ≥18 years.\n* Self-report smoking in the past 7 days, biochemically verified with saliva cotinine ≥ 30 ng\u002FmL (positive result based on at-home saliva swab test provided by study team).\n* Smoked ≥ 3 cigarettes per day over the past 3 months.\n* Considering or willing to make a quit attempt.\n* Have or will nominate one adult family member to enroll with them.\n* Own or have access to a mobile phone or tablet with Internet and text messaging capabilities, or will be loaned an iPad for the study duration\n* Willing to upload photos of self during completion of smoking status tests.\n* Willing to complete and sign an Internal Revenue Service (IRS) W-9 tax identification form if they wish to receive payments on the study.\n* Willing to provide written informed consent and participate in study-related tests and procedures.\n\nIndex Participant Exclusion Criteria:\n\n* Already enrolled in the study with another family member.\n* Participated in a prior study phase.\n\nFamily Member Participant Inclusion Criteria (regardless of smoking status or residence with the index participant):\n\n* Age ≥18 years.\n* Defined as family and nominated by the index participant, or have an ANAI family member who is ≥18 years and smokes that they would like to support in quitting.\n* Own or have access to a mobile phone or tablet with Internet and text messaging capabilities, or will be loaned an iPad for the study duration.\n* Willing to complete and sign an IRS W-9 tax identification form if they wish to receive payments on the study.\n* Willing to provide written informed consent and participate in study related tests and procedures.\n\nBoth men and women, those from non-ANAI racial\u002Fethnic groups, and those who live outside of Alaska in the United States will be eligible family member participants.\n\nFamily Member Participant Exclusion Criteria:\n\n* Already enrolled with another family member.\n* Participated in a prior study phase.\n\nAfter the randomized controlled trial, qualitative interviews will be conducted with index participants, family member participants, and Alaska Tribal Health System Stakeholders to inform program implementation. Healthcare providers, cessation specialists, Elder advisors, and Tribal Health System leaders and stakeholders will be invited by the Alaska Native Tribal Health Consortium team and separately consented and interviewed.",[70,71],"ADULT","OLDER_ADULT",[73],{"facility":74,"status":8,"city":75,"state":76,"zip":77,"country":78,"contacts":79,"geoPoint":89},"Alaska Native Tribal Health Consortium","Anchorage","Alaska","99508","United States",[80,85],{"name":81,"role":82,"phone":83,"email":84},"Timothy K Thomas, MD","CONTACT","907-729-1900","tkthomas@anthc.org",{"name":86,"role":82,"phone":87,"email":88},"Barb J Stillwater, PhD","1-907-729-1900","bjstillwater@anthc.org",{"lat":90,"lon":91},61.21806,-149.90028,[93,97],{"name":94,"role":82,"phone":95,"email":96},"Christi A Patten, PhD","507-261-0718","patten.christi@mayo.edu",{"name":98,"role":82,"phone":99,"email":100},"Audrey G McGuinness, BA","1-507-422-5074","McGuinness.Audrey@mayo.edu",[102],{"name":94,"affiliation":13,"role":103},"PRINCIPAL_INVESTIGATOR",[105,109,112],{"pmid":106,"type":107,"citation":108},"37091507","BACKGROUND","Patten CA, Koller KR, King DK, Prochaska JJ, Sinicrope PS, McDonell MG, Decker PA, Lee FR, Fosi JK, Young AM, Sabaque CV, Brown AR, Borah BJ, Thomas TK. Aniqsaaq (To Breathe): Study protocol to develop and evaluate an Alaska Native family-based financial incentive intervention for smoking cessation. Contemp Clin Trials Commun. 2023 Apr 3;33:101129. doi: 10.1016\u002Fj.conctc.2023.101129. eCollection 2023 Jun.",{"pmid":110,"type":107,"citation":111},"38642396","Sinicrope PS, Tranby BN, Young AM, Koller KR, King DK, Lee FR, Sabaque CV, Prochaska JJ, Borah BJ, Decker PA, McDonell MG, Stillwater B, Thomas TK, Patten CA. Adapting a Financial Incentives Intervention for Smoking Cessation With Alaska Native Families: Phase 1 Qualitative Research to Inform the Aniqsaaq (To Breathe) Study. Nicotine Tob Res. 2024 Sep 23;26(10):1377-1384. doi: 10.1093\u002Fntr\u002Fntae092.",{"pmid":113,"type":107,"citation":114},"40224301","Tranby BN, Young AM, Roche AI, Lee FR, Brown AR, Stillwater BJ, Prochaska JJ, King DK, Decker PA, Borah BJ, McDonell MG, Thomas TK, Patten CA. Beta-testing the feasibility of a family-based financial incentives smoking cessation intervention with Alaska Native families: Phase 2 of the Aniqsaaq (to breathe) Study. Contemp Clin Trials Commun. 2025 Mar 17;45:101472. doi: 10.1016\u002Fj.conctc.2025.101472. eCollection 2025 Jun.",[],{"nct_id":4,"conditions":117,"biomarkers":118},[19],[],{"nct_id":4,"found":120,"summary":121,"prompt_version":131},true,{"design":122,"status":123,"heading":124,"summary":125,"follow_up":126,"word_count":127,"commitments":128,"compensation":129,"drugs_mentioned":130},"This is a randomized controlled trial, meaning participants will be randomly assigned to either receive financial incentives or not. The study plans to enroll 1312 participants.","completed","Family-Based Financial Incentives for Smoking Cessation","This study is testing if financial rewards given to families can help Alaska Native\u002FAmerican Indian (ANAI) individuals stop smoking. You might be able to join if you are an ANAI person living in Alaska, are at least 18 years old, and smoke at least 3 cigarettes a day. Your smoking will be checked with a saliva test. The study will compare people who receive financial incentives for quitting smoking to those who don't, to see if the incentives help people stay smoke-free for 6 and 12 months. The study aims to enroll 1312 participants, but its current status is unclear.","The study will measure changes in smoking status at 6 months and 12 months after the intervention.",100,"You will receive existing cessation materials. Your smoking status will be checked weekly for the first four weeks, and then at three and six months. If you are in the incentive group, you will receive rewards for verified smoking abstinence.","Participants, including support persons, will receive incentives for completing smoking status assessments. The intervention group can receive up to $750 for achieving verified smoking abstinence, with enrolled family members receiving equivalent rewards.",[],"v2"]