[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05169385":3,"trial-entities:NCT05169385":147,"trial-summary:NCT05169385":151},{"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":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":42,"secondary_outcomes":59,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":87,"locations":90,"central_contacts":126,"overall_officials":134,"references":138,"see_also_links":146},"NCT05169385","2006002748","Parent SMART (Substance Misuse in Adolescents in Residential Treatment)","Improving Outcomes of Adolescents in Residential Substance Use Treatment Via a Technology-Assisted Parenting Intervention","RECRUITING","2027-02-02","2025-04","2025-04-03","2022-03-01","Brown University","OTHER",true,"Adolescents in residential substance use treatment have serious substance-related problems and poor outcomes following discharge: follow-up studies indicate that 60% of adolescents treated in residential treatment will relapse within the first 90 days. Parenting practices have been established as a critical predictor of adolescents' substance use outcomes and likelihood of relapse following treatments, but parents are notoriously difficult to engage in adolescent substance use treatment. Findings such as these provide strong justification for targeting parents of adolescents in residential substance use treatment via easily accessible interventions.\n\nThis study tests the effectiveness of a technology-assisted parenting intervention called Parent SMART (Substance Misuse among Adolescents in Residential Treatment). The intervention combines an off-the-shelf computer program that teaches parenting skills called Parenting Wisely, four telehealth coaching sessions, and a networking forum that allows parents to connect with a clinical expert and with other parents. The investigators will compare adolescents who receive standard residential substance use treatment to adolescents who receive the same treatment plus whose parents receive Parent SMART. Investigators will test the comparative effectiveness of Parent SMART versus residential treatment as usual on parental monitoring and communication, adolescent substance use (i.e., days of substance use and substance-related problems), and substance-related high-risk behaviors (i.e., school-related problems, criminal involvement, externalizing behavior). The investigators will also test whether improvements in parenting partially mediate any observed changes in adolescent substance use and other high-risk behaviors.","Building upon a successful National Institute on Drug Abuse (NIDA)-funded R34, this study evaluates a technology-assisted parenting intervention with evidence of high feasibility and acceptability, as well as preliminary evidence of effectiveness as an adjunct to residential treatment as usual (TAU). Specifically, this study involves a fully powered evaluation of Parent SMART (Substance Misuse among Adolescents in Residential Treatment), which was developed based on extensive formative research with parents, adolescents, and residential treatment staff, and subsequently tested in a NIDA-funded pilot trial.\n\nParent SMART was intentionally designed with scalability in mind. It consists of an off-the-shelf computer program called Parenting Wisely (PW) that has robust evidence of efficacy in improving parenting skills and reducing youth behavior problems across five clinical trials. Guided by formative research, Parent SMART augments PW with four telehealth coaching sessions and access to a state-of-the-art, mobile networking forum (available via both mobile phone app and web browser), where parents can submit questions to an expert and connect with other parents of adolescents in residential substance use treatment. Parent SMART was piloted at both short (i.e., 6-10 day length of stay) - and long-term (i.e., 30-45 day length of stay) residential facilities: the model was feasible and acceptable in both settings, and effective at improving parental monitoring and communication in both settings. In the short-term setting, Parent SMART was also effective at reducing days of substance use (i.e., days of binge drinking, days of all other drug use) and reducing school problems: the pilot project was underpowered to detect differences at the long-term setting. The current trial is a fully powered evaluation of Parent SMART as an adjunct to residential treatment as usual.\n\nAdolescent-parent dyads (n = 220; 440 participants) will be randomized to receive either residential treatment as usual (TAU) only or Parent SMART + TAU. Those randomized to TAU will be offered the technology-delivered elements of Parent SMART at the 6-month follow-up. Parent SMART telehealth sessions will be delivered by bachelor's and master's level counselors to enhance scalability. Multi-method follow-up assessments (i.e., self-report measures, videotaped interaction task, urine screens) will be conducted 6-, 12-, and 24-weeks post-discharge.\n\nThe primary aims of this study is to examine the effectiveness of Parent SMART as an adjunctive treatment, relative to adolescent residential treatment-as-usual on: parenting processes (Primary Aim 1) and adolescent substance use outcomes (Primary Aim 2). A secondary aim is to test the effectiveness of Parent SMART compared to residential treatment-as-usual on adolescent high-risk behaviors. An additional Exploratory Aim will test whether change in parenting processes mediates change in adolescent substance use outcomes.\n\nPursuit of these aims is significant given the potential to improve the outcomes of adolescents following discharge from residential substance use treatment by offering their parents a novel technology-assisted intervention. Technology-assisted interventions have the potential for marked public health impact by extending the reach, duration, and scalability of evidence-based care.",[19,20],"Substance Use","Adolescent Behavior",[22,23,24],"adolescent","substance use","substance-related disorders","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},220,"ESTIMATED",[33,38],{"type":34,"name":35,"description":36,"armGroupLabels":37},"BEHAVIORAL","Parent SMART","Parent SMART experimental intervention",[35],{"type":34,"name":39,"description":40,"armGroupLabels":41},"Treatment as Usual","Residential treatment as usual",[39],[43,47,50,53,56],{"measure":44,"description":45,"timeFrame":46},"Change in Parental Monitoring","The Parental Monitoring Questionnaire (PMQ), a parent-report and adolescent-report measure, will be used to assess dimensions of parental monitoring. It has three subscales: Child Disclosure, Parent Solicitation, and Parental Control.","Baseline to 24 Weeks Post Discharge",{"measure":48,"description":49,"timeFrame":46},"Change in Parental Communication","The Parent-Adolescent Communication Scale (PCAS), a parent-report and adolescent-report measure, will be used to assess dimensions of parental monitoring. It has two subscales: General Communication and Problems with Communication.",{"measure":51,"description":52,"timeFrame":46},"Change in Family Assessment Task Interaction Ratings","The Family Assessment Task, a video-taped family problem solving task will be used to provide an in vivo assessment of parenting behavior. Three tasks provide data on monitoring and communication: Limit Setting, Substance Use Norms, and Monitoring and Listening. Tapes will be coded by two raters blind to condition.",{"measure":54,"description":55,"timeFrame":46},"Change in Proportion of Days Used Over the Past 90 Days Outside of a Controlled Environment","The Global Appraisal of Individual Needs - Core is a well-validated clinical interview used to assess adolescent substance use in a range of settings. Substance consumption information is collected using a calendar format with temporal cues (e.g., holidays) to assist in recall of days when alcohol and other drugs were used. Possible number of days range from 0 to 90. Values are adjusted to reflect the percent of days used outside of controlled environment, with final values ranging from 0 to 100%.",{"measure":57,"description":58,"timeFrame":46},"Change in Substance Use Problems","The Global Appraisal of Individual Needs - Core is a well-validated clinical interview used to assess adolescent substance use in a range of settings. The Substance-Related Problems Scale provides a count of substance-related problems experienced over the past 90 days. Possible values range from 0 to 11.",[],"ALL","12 Years","18 Years",false,{"inclusion":65,"exclusion":76,"raw_text":86},[66,67,68,69,70,71,72,73,69,74,75],"admitted to residential treatment due to concerns about frequency and\u002For severity of substance use","report alcohol and\u002For drug use in the past 90 days","be discharged to live with primary guardian","fluent in English or Spanish","willing and able to participate in a 2 hour interview prior to discharge from residential","parent or legal guardian of adolescent aged 12-18 years inclusive, at project start","adolescent admitted to residential treatment due to concerns about frequency and\u002For severity of substance use","will be primary guardian living with adolescent after discharge from residential","willing and able to complete the baseline assessment prior to the adolescent's discharge","access to a smartphone that can receive text messages and reliably access the internet",[77,78,79,80,81,82,83,79,84,85],"does not report alcohol or drug use in the past 90 days","discharge plan does not include living with primary guardian","not fluent in English or Spanish","not willing or able to complete baseline interview","not legal guardian of adolescent or adolescent not aged between 12-18 years","adolescent not admitted to residential treatment due to substance use concerns","will not be living with adolescent after adolescent's discharge from residential","not willing or able to complete the baseline assessment prior to the adolescent's discharge","does not have access to a smartphone that can receive text messages and reliably access the internet","Inclusion Criteria for Adolescents:\n\n* admitted to residential treatment due to concerns about frequency and\u002For severity of substance use\n* report alcohol and\u002For drug use in the past 90 days\n* be discharged to live with primary guardian\n* fluent in English or Spanish\n* willing and able to participate in a 2 hour interview prior to discharge from residential\n\nExclusion Criteria for Adolescents:\n\n* does not report alcohol or drug use in the past 90 days\n* discharge plan does not include living with primary guardian\n* not fluent in English or Spanish\n* not willing or able to complete baseline interview\n\nInclusion Criteria for Parents:\n\n* parent or legal guardian of adolescent aged 12-18 years inclusive, at project start\n* adolescent admitted to residential treatment due to concerns about frequency and\u002For severity of substance use\n* will be primary guardian living with adolescent after discharge from residential\n* fluent in English or Spanish\n* willing and able to complete the baseline assessment prior to the adolescent's discharge\n* access to a smartphone that can receive text messages and reliably access the internet\n\nExclusion Criteria for Parents:\n\n* not legal guardian of adolescent or adolescent not aged between 12-18 years\n* adolescent not admitted to residential treatment due to substance use concerns\n* will not be living with adolescent after adolescent's discharge from residential\n* not fluent in English or Spanish\n* not willing or able to complete the baseline assessment prior to the adolescent's discharge\n* does not have access to a smartphone that can receive text messages and reliably access the internet",[88,89],"CHILD","ADULT",[91,104,113],{"facility":92,"status":8,"city":93,"state":94,"zip":95,"country":96,"contacts":97,"geoPoint":101},"Rosecrance Health Network","Rockford","Illinois","61107","United States",[98],{"name":99,"role":100},"Renee Wihlborg, MD","CONTACT",{"lat":102,"lon":103},42.27113,-89.094,{"facility":105,"status":106,"city":107,"state":108,"zip":109,"country":96,"geoPoint":110},"Rosecrance Jackson Centers","COMPLETED","Sioux City","Iowa","51101",{"lat":111,"lon":112},42.49999,-96.40031,{"facility":114,"status":8,"city":115,"state":116,"zip":117,"country":96,"contacts":118,"geoPoint":123},"Hazelden Betty Ford","Plymouth","Minnesota","55441",[119],{"name":120,"role":100,"phone":121,"email":122},"Quyen Ngo, PhD, LP","651-213-4106","qngo@hazeldenbettyford.org",{"lat":124,"lon":125},45.01052,-93.45551,[127,131],{"name":128,"role":100,"phone":129,"email":130},"Sara J Becker, Ph.D.","312-503-4203","sara.becker@northwestern.edu",{"name":132,"role":100,"phone":129,"email":133},"Sarah Helseth, Ph.D.","sarah.helseth@northwestern.edu",[135],{"name":128,"affiliation":136,"role":137},"Brown University and Northwestern University","PRINCIPAL_INVESTIGATOR",[139,143],{"pmid":140,"type":141,"citation":142},"39425208","DERIVED","Patel-Syed Z, Helseth SA, Rosales R, Janssen T, Scott K, Becker SJ. The effects of neighborhood perceptions on response to a technology-assisted parenting intervention for adolescent substance use: protocol of a diversity supplement to parent SMART (Substance Misuse in Adolescents in Residential Treatment). Addict Sci Clin Pract. 2024 Oct 18;19(1):75. doi: 10.1186\u002Fs13722-024-00509-y.",{"pmid":144,"type":141,"citation":145},"35225821","Becker SJ, Helseth SA, Kelly LM, Janssen T, Wolff JC, Spirito A, Wright T. Parent SMART (Substance Misuse in Adolescents in Residential Treatment): Protocol of a Randomized Effectiveness Trial of a Technology-Assisted Parenting Intervention. JMIR Res Protoc. 2022 Feb 28;11(2):e35934. doi: 10.2196\u002F35934.",[],{"nct_id":4,"conditions":148,"biomarkers":150},[149],"Substance-Related Disorder",[],{"nct_id":4,"found":15,"summary":152,"prompt_version":162},{"design":153,"status":154,"heading":155,"summary":156,"follow_up":157,"word_count":158,"commitments":159,"compensation":160,"drugs_mentioned":161},"This is an interventional study comparing Parent SMART to usual residential treatment, with a planned enrollment of 220 participants.","completed","Parent SMART for Adolescents in Residential Substance Use Treatment","This study is testing a program called Parent SMART, which aims to help parents of adolescents (ages 12-18) who are in residential treatment for substance use. Many adolescents relapse after leaving residential treatment, and this study believes that involving parents can help. Parent SMART combines a computer program called Parenting Wisely with coaching sessions and an online forum for parents. The study will compare Parent SMART to standard residential treatment. Researchers will measure changes in how parents monitor their children, how they communicate, and how families interact, from the start of the study until 24 weeks after discharge. The study plans to enroll 220 participants, but its current status is unclear.","Participants will be followed for 24 weeks after discharge from residential treatment.",111,"Adolescents must be willing and able to participate in a 2-hour interview before leaving residential treatment. Not specified in the trial record.","Not stated in the trial record.",[35],"v2"]