[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633641":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":41,"centralContacts":46,"locations":56,"responsibleParty":75,"collaborators":77,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":34,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":34,"enrollmentInfo":90,"targetDuration":34,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":103,"overallStatus":58,"whyStopped":34,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"University of Oregon","OTHER",[8,16,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Interaction Review Enhancement & Practical Supports Enhancement","ACTIVE_COMPARATOR","Participants receive the Comilia Group intervention plus the interaction review sessions and practical support sessions.",[13,14,15],"Behavioral: Comilia Group","Behavioral: Interaction Review Enhancement","Behavioral: Practical Support Enhancement",{"label":17,"type":10,"description":18,"interventionNames":19},"Comilia Group Only","Participants receive the Comilia Group intervention only.",[13],{"label":21,"type":10,"description":22,"interventionNames":23},"Interaction Review Enhancement","Participants receive the Comilia Group intervention plus the Interaction Review Enhancement.",[13,14],{"label":25,"type":10,"description":26,"interventionNames":27},"Practical Support Enhancement","Participants receive the Comilia Group intervention plus the Practical Support Enhancement.",[13,15],[29,35,38],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"BEHAVIORAL","Comilia Group","Parents participate in six weekly 90-minute in-person groups led by a trained facilitator and offered in English or Spanish. Groups use modeled caregiver-child interaction videos and guided discussion to teach evidence-based communication strategies.",[17,21,9,25],null,{"type":30,"name":21,"description":36,"armGroupLabels":37,"otherNames":34},"Parents receive three one-hour telehealth coaching sessions with a licensed speech-language pathologist to review caregiver-child interactions, practice communication strategies, and receive individualized feedback.",[21,9],{"type":30,"name":25,"description":39,"armGroupLabels":40,"otherNames":34},"Participants receive three one-hour telehealth sessions focused on identifying barriers to using the communication strategies introduced in the group sessions. Interventionists work with parents to develop structured supports (e.g., mindfulness tools, visual aids, tracking logs, timers) and set goals to address planning, attention, or memory challenges that may interfere with implementation.",[9,25],[42],{"name":43,"affiliation":44,"role":45},"Camille Cioffi","Prevention Science Institute","PRINCIPAL_INVESTIGATOR",[47,52],{"name":48,"role":49,"phone":50,"phoneExt":34,"email":51},"Stephanie De Anda, PhD, CCC-SLP","CONTACT","541-346-8530","sdeanda@uoregon.edu",{"name":53,"role":49,"phone":54,"phoneExt":34,"email":55},"Maya Casper","775-848-8727","mcasper@uoregon.edu",[57],{"facility":44,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"RECRUITING","Eugene","Oregon","97403","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-123.08675,44.05207,{"lat":68,"lon":67},[71,73,74],{"name":72,"role":49,"phone":50,"phoneExt":34,"email":51},"Stephanie De Anda",{"name":53,"role":49,"phone":54,"phoneExt":34,"email":55},{"name":43,"role":45,"phone":34,"phoneExt":34,"email":34},{"type":76,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[78],{"name":79,"class":80},"National Institute on Deafness and Other Communication Disorders (NIDCD)","NIH","100633641","prevent-language-delays-and-disorders-among-children-of-caregivers-with-substance-use-disorders-with-community-groups-and-individualized-services-100633641",false,"NCT07529327","Prevent Language Delays and Disorders Among Children of Caregivers With Substance Use Disorders With Community Groups and Individualized Services","Evidence-based Intervention Enhancements to Reduce Language Delays and Disorders Among Children of Parents With Substance Use Disorders","Inclusion Criteria:\n\n1. Have a:\n\n   1. Self-reported lifetime history of substance use disorder treatment and\u002For\n   2. active substance use in the past year\n2. Be providing care for\u002Fparenting a child at least 10% of the time who is:\n\n   1. between the ages of 12-42 months\n   2. English\u002FSpanish bilingual or monolingual in English or Spanish\n   3. exposed to a third language once a week or less\n   4. not yet combining three or more words regularly\n   5. has less than 150 words in their expressive vocabulary\n3. Be able to provide consent for their target child to participate, or have a legal guardian provide consent for the child to participate\n4. Be able to speak and understand English and\u002For Spanish\n5. Be willing to attend groups once a week for six weeks at a participating site\u002Fgroup time\n6. If assigned additional services, willing to attend Zoom meetings\n7. Be 18 years of age or older\n\nExclusion Criteria:\n\n-Only one caregiver per focal child can participate in the research study. Caregivers whose participating child already has another caregiver enrolled in the research study will not be eligible to participate.","ALL","18 Years",{"count":91,"type":92},244,"ESTIMATED","INTERVENTIONAL",[95],"NA","The goal of this clinical trial is to test ways to improve early language development among young children of parents with substance use disorder (SUD). Children of parents with SUD are at increased risk for language delays, and early supports may help prevent long-term learning challenges. This study will examine whether adding additional supports to group-based parenting intervention improves child language outcomes compared to the group intervention alone.",[98,99,100,101,102],"Language Delay","Substance Use Disorders","Language Disorders in Children","Language Development","Prevention Intervention",[104,105,106,107],"Naturalistic communication intervention","Parenting","Group based intervention","Vocabulary Acquisition","2026-04-14",{"date":110,"type":111},"2026-04-20","ACTUAL",{"date":113,"type":111},"2026-03-10",{"date":115,"type":92},"2029-11-30",{"name":5,"class":6},1]