[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07718022":3,"trial-entities:NCT07718022":138,"trial-summary:NCT07718022":141},{"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":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":45,"secondary_outcomes":54,"sex":91,"minimum_age":92,"maximum_age":93,"healthy_volunteers":94,"eligibility_criteria":95,"std_ages":103,"locations":107,"central_contacts":122,"overall_officials":130,"references":136,"see_also_links":137},"NCT07718022","STUDY25020077","Caregiver-Adolescent Dating Violence Prevention Intervention Pilot Trial","Relationship Abuse Prevention Intervention Implemented With Sexual and Gender Diverse Youth and Their Caregivers - Pilot Trial","NOT_YET_RECRUITING","2028-07-01","2026-07","2026-07-21","2026-08-01","University of Pittsburgh","OTHER",false,"This is a pilot clinical trial to test an intervention called FLARE, which is an adolescent relationship abuse prevention program for sexual and gender diverse youth and their trusted adults. FLARE comprises in-person, virtual, and asynchronous programming developed by and for caregivers and adolescents.","In this pilot trial, the investigators will be testing FLARE, a dating violence prevention program for sexual and gender diverse youth and their trusted adults. The study will be comparing FLARE to a wait-list control. This trial will focus on assessing acceptability, feasibility, and fidelity, as well as exploratory changes in behavioral outcomes. FLARE includes 1 in-person full day session, 2 virtual large group sessions, and several asynchronous components (website, workbook, card game). FLARE runs over a 4 week period.",[19,20],"Adolescent Relationship Abuse","Sexual and Gender Minorities",[22,23,24,25],"adolescent relationship abuse","parental monitoring","intervention","sexual and gender diverse youth","INTERVENTIONAL","PREVENTION",[29],"NA",{"count":31,"type":32},108,"ESTIMATED",[34,40],{"type":35,"name":36,"description":37,"armGroupLabels":38},"BEHAVIORAL","FLARE","Adolescent relationship abuse prevention intervention for sexual and gender diverse youth and their trusted adults",[39],"FLARE intervention",{"type":35,"name":41,"description":42,"armGroupLabels":43},"Resource Guide","The control group will receive a resource guide and then will be able to receive FLARE after the trial is complete as a wait list control option",[44],"Wait list control",[46,50],{"measure":47,"description":48,"timeFrame":49},"Acceptability","Acceptability of Intervention Measure: Mean value of 4 items. Each question uses a five-point Likert scale for responses, coded with a value from 1 (Completely disagree) to 5 (Completely agree) and averaged to produce the mean value. The higher the computed mean value, the greater acceptability of the intervention.","T2 (1 month post baseline)",{"measure":51,"description":52,"timeFrame":53},"Trial Feasibility","Trial Consent Rate: % of individuals who assented\u002Fconsented to participate out of individuals who screened eligible\n\nTrial Baseline Participation Rate: % of individuals who completed the baseline survey out of individuals who assented\u002Fconsented to participate\n\nTrial Intervention Demand: % of intervention arm participants who complete the intervention\n\nTrial Retention Rate: % of participants who complete each followup survey","T1 (baseline); T2 (1 month post baseline); T3 (3 months post baseline, 2 months post T2)",[55,59,62,64,67,70,73,76,79,82,85,88],{"measure":56,"description":57,"timeFrame":58},"Attitudes about abusive behaviors","Recognition of Abusive Behaviors Scale: Mean of the 8 items that use 5-point Likert response options, where higher scores indicate greater recognition of abusive behaviors.","T1 (baseline); T3 (3 months post baseline, 2 months post T2)",{"measure":60,"description":61,"timeFrame":58},"Attitudes towards diverse identities","Attitudes Towards Diverse Identities and Expressions: Mean value of 6 items about sexual diverse youth and mean value of 7 items about gender diverse youth. Items use 5-point Likert scales. Higher average scores indicate more positive attitudes.",{"measure":63,"description":61,"timeFrame":58},"Self-efficacy",{"measure":65,"description":66,"timeFrame":58},"Parenting confidence","Sexuality-related parenting practice confidence: Mean value of the sexuality-related parenting practice confidence subscale containing 17 items that uses a 10-point Likert scale, wherein higher mean values indicate greater confidence.",{"measure":68,"description":69,"timeFrame":58},"Caregiver self-efficacy","Affirmative Caregiving Self-Efficacy Inventory: Mean value of 20-item scale using 5-point Likert response options designed to assess caregivers' confidence in their abilities to engage in affirmative caregiver practices with SGDY. Higher mean values indicate greater self-efficacy.",{"measure":71,"description":72,"timeFrame":58},"Motivation","Motivation change ruler: The motivation change ruler assesses motivation for preventing ARA and engaging in monitoring activities with a total of 4 items and Likert scale response option. Each item will be used individually, and higher values indicate greater motivation.",{"measure":74,"description":75,"timeFrame":58},"Resource utilization","Utilization of dating\u002FARA resources: Utilization of dating\u002FARA resources is assessed using 6 items with Likert scale response options. Higher scores indicate greater utilization of dating\u002FARA resources.",{"measure":77,"description":78,"timeFrame":58},"Dating related parenting monitoring","Exposure to opportunities for engaging in dating\u002FARA monitoring activities is assessed using 5 with Likert scale response options. Higher scores indicate greater exposures to opportunities for engaging in dating\u002FARA monitoring activities.",{"measure":80,"description":81,"timeFrame":58},"Parenting monitoring","Mean value of the 18 items using Likert scale response options, wherein higher schools indicate greater positive parenting practices.",{"measure":83,"description":84,"timeFrame":58},"LGBTQ Caregiver","LGBTQ Caregiver Acceptance Scale: Mean values will be calculated for each of the subscales, which include outness (10 items), caregiver acceptance (6 items), concealment (6 items), respect (9 items), attitudes toward parenting SGDY (4 items), supportive action (5 items). Response options use a 6-point Likert scale. Higher mean values indicate greater levels of positive outcomes, except for concealment where lower values indicate positive outcomes.",{"measure":86,"description":87,"timeFrame":58},"parent-adolescent communication","5 item investigator developed measure around parent-adolescent communication on dating and dating violence. Summary score, higher mean is more communication",{"measure":89,"description":90,"timeFrame":58},"Adolescent relationship abuse","Measure of Adolescent Relationship Harassment and Abuse (MARSHA): Developed specifically by and for marginalized youth including SGDY, MARSHA assesses the frequency adolescent relationship abuse among adolescents. MARSHA included items assessing ARA victimization (39) and perpetration (39) frequency, with subscales pertain to privacy control, social control, physical abuse, sexual abuse, and intimidation. Response options include: 0 times, 1-3 times, 4-10 times, more than 10 times. Summary scores are created for each subscale by dichotomizing the items (0 vs 1) and adding them together. Higher scores indicate greater ARA.","ALL","14 Years",null,true,{"inclusion":96,"exclusion":98,"raw_text":102},[97],"SGDY eligibility includes:",[99,100,101],"Does not meet eligibility criteria","Incarcerated during the study","Unable to provide verbal or REDCap consent or assent","Inclusion Criteria:\n\n* SGDY eligibility includes:\n\n  1. ages 14 to 18\n  2. identifies as sexually or gender diverse (e.g., gay, lesbian, bisexual, queer, transgender, or nonbinary)\n  3. uses English\n  4. willing to travel to Pittsburgh for 1 in-person event; and\n  5. can identify a caregiver who can also participate.\n\nCaregivers eligibility includes:\n\n1. age 18 or older;\n2. a caregiver of an SGDY ages 14 to 18;\n3. uses English;\n4. willing to travel to Pittsburgh for 1 in-person event; and\n5. has a child participating in this study. Caregivers can include parents or any other person whom the adolescent identifies as a trusted adult in their life. We will only enroll 1 caregiver for each SGDY; because this is a dyadic study each adolescent needs a matched participating caregiver and vice versa.\n\nExclusion Criteria:\n\n* Does not meet eligibility criteria\n* Incarcerated during the study\n* Unable to provide verbal or REDCap consent or assent",[104,105,106],"CHILD","ADULT","OLDER_ADULT",[108],{"facility":13,"city":109,"state":110,"zip":111,"country":112,"contacts":113,"geoPoint":119},"Pittsburgh","Pennsylvania","15213","United States",[114],{"name":115,"role":116,"phone":117,"email":118},"Erin Mickievicz, BA","CONTACT","4126926000","mickieviczee@upmc.edu",{"lat":120,"lon":121},40.44062,-79.99589,[123,127],{"name":124,"role":116,"phone":125,"email":126},"Maya Ragavan, MD","6506449954","ragavanm@chp.edu",{"name":128,"role":116,"email":129},"Robert Coulter, PhD","robert.ws.coulter@pitt.edu",[131,134],{"name":132,"affiliation":13,"role":133},"Maya I Ragavan","PRINCIPAL_INVESTIGATOR",{"name":135,"affiliation":13,"role":133},"Robert Coulter",[],[],{"nct_id":4,"conditions":139,"biomarkers":140},[19,20],[],{"nct_id":4,"found":94,"summary":142,"prompt_version":151},{"design":143,"status":144,"heading":6,"summary":145,"follow_up":146,"word_count":147,"commitments":148,"compensation":149,"drugs_mentioned":150},"This is an interventional pilot trial with 108 planned participants. It compares the FLARE program to a control group that receives a resource guide.","completed","This pilot study is testing a program called FLARE, which aims to prevent dating violence among sexual and gender diverse youth (SGDY) and their trusted adults. FLARE involves in-person and online activities. We are looking for 108 participants, including youth aged 14-18 who identify as sexually or gender diverse, speak English, and can travel to Pittsburgh for one event. They also need a caregiver (18 or older) to participate. The study will compare FLARE to a resource guide, with the resource guide group getting access to FLARE later. We want to see if FLARE is acceptable and practical, and if it helps with behavioral changes. The study's current status is unclear.","Participants will be followed for 3 months after the initial baseline assessment.",111,"You would participate in a program over a 4-week period, including one full day in-person session, two virtual group sessions, and online activities. You would also complete assessments at baseline, 1 month, and 3 months.","Not stated in the trial record.",[36,41],"v2"]