[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06275815":3,"trial-entities:NCT06275815":134,"trial-summary:NCT06275815":139},{"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":15,"conditions":17,"keywords":20,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":56,"secondary_outcomes":75,"sex":76,"minimum_age":77,"maximum_age":78,"healthy_volunteers":79,"eligibility_criteria":80,"std_ages":88,"locations":90,"central_contacts":125,"overall_officials":130,"references":132,"see_also_links":133},"NCT06275815","R01DC020958","Promoting Caregiver Implementation of an Effective Early Learning Intervention","Promoting Caregiver Implementation of an Effective Early Learning Intervention: Sit Together and Read (STAR)","RECRUITING","2028-07-31","2025-09","2025-09-30","2024-04-10","Ohio State University","OTHER",null,"The goal of this study is to examine the impact of a caregiver-implemented shared reading program, Sit Together and Read (STAR), on children ages 4 to 5 with developmental language disorder. The main questions it aims to answer are:\n\n* how much STAR impacts children's literacy skills in the short-term and long-term--up to two-years after completing STAR.\n* how do caregiver supports in the form of small monetary rewards or encouraging texts help caregivers to implement STAR at its intended frequency of sessions per week.\n\nCaregiver participants will be assigned to either a control group or one of three STAR groups. Children's skills related to literacy and learning will be assessed before the intervention starts, at the end of the intervention, and every six months post-intervention for two years.\n\nResearchers will determine the short term and long term impacts of STAR compared to the control group. Researchers will compare the three STAR conditions to see if the rewards or encouragement helped parents to follow through with completing more STAR sessions.",[18,19],"Developmental Language Disorder","Reading; Difficult",[21,22,23,24,25,26],"Randomized Control Trial","Print Knowledge","Reading Outcomes","literacy","behavior-change strategies","early literacy","INTERVENTIONAL","PREVENTION",[30],"NA",{"count":32,"type":33},320,"ESTIMATED",[35,45,50],{"type":14,"name":36,"description":37,"armGroupLabels":38,"otherNames":42},"Sit Together and Read (STAR)","Sit Together and Read (STAR) features an explicit, systematic sequence of 15 objectives that target four dimensions of print knowledge: print organization, print meaning, letters, and words. These objectives are explicitly targeted in the context of repeated adult-child shared reading sessions and are systematically cycled over an intervention period so the child has repeated opportunities for acquiring the targeted print objectives. STAR is a manualized 15-week intervention.",[39,40,41],"STAR + Reward","STAR + text encouragement","STAR Only",[43,44],"STAR Read-Aloud Practices","Read-Aloud Practices",{"type":46,"name":47,"description":48,"armGroupLabels":49},"BEHAVIORAL","Monetary Reward","Caregiver receives a monetary reward of $0.50 for each session logged (up to 60 sessions) and audio-recording completed (up to 15 audio recordings).",[39],{"type":46,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Text Encouragement","Caregiver receives three tailored encouraging text messages specific to each week of the Sit Together and Read intervention.",[40],[55],"SMS Messaging",[57,61,64,67,71],{"measure":58,"description":59,"timeFrame":60},"Preschool Word and Print Awareness (PWPA)","Standardized criterion-referenced measure of children's knowledge of 15 basic print concepts","Pretest before intervention and post-test immediately following intervention",{"measure":62,"description":63,"timeFrame":60},"Phonological Awareness Literacy Screening (PALS): Alphabet Knowledge and Name Writing","PALS-Preschool is a scientifically-based phonological awareness and literacy screening and progress measure that assesses preschoolers' developing knowledge of important literacy fundamentals. The assessment reflects skills that are predictive of future reading success. We administer two subtests that measures name writing ability and upper-case and lower-case alphabet recognition.",{"measure":65,"description":66,"timeFrame":60},"The Reading House (THR)","A direct screening tool developed for use with pediatricians that allows a variety of providers to identify children who may be at risk for reading difficulties. It is a direct, book-based screener grounded in the concept of emergent literacy. TRH assessment examines 1) print knowledge, 2) alphabet knowledge, 3) letter-sound knowledge, 4) phonological awareness, 5) vocabulary, and 6) emergent writing.",{"measure":68,"description":69,"timeFrame":70},"Woodcock Johnson Test of Achievement- IV (WJ-IV): Word Attack and Letter-Word Identification","We administer two subtests of the norm referenced, standardized WJ-IV, Word Attack and Letter-Word Identification. Measure of child literacy and reading skill. We will explore avenues for data reduction, including use of a latent-variable modeling strategy.","Completed at all assessing timepoints. Pretest, immediate post-test, 6 month follow-up, 12 month follow-up, 18 month follow-up, 24 month follow up.",{"measure":72,"description":73,"timeFrame":74},"Woodcock Johnson Test of Achievement- IV (WJ-IV): Spelling, Passage Comprehension","We administer two subtests of the norm referenced, standardized WJ-IV, Spelling and Passage Comprehension. Measure of child literacy and reading skill","6 month follow-up, 12 month follow-up, 18 month follow-up, 24 month follow up.",[],"ALL","48 Months","71 Months",false,{"inclusion":81,"exclusion":86,"raw_text":87},[82,83,84,85],"receiving or on waitlist for speech services","primary complaint of impaired language skills","receptive, expressive, or mixed language disorder","primarily communicates in English",[],"Inclusion Criteria:\n\n* receiving or on waitlist for speech services\n* primary complaint of impaired language skills\n* receptive, expressive, or mixed language disorder\n* primarily communicates in English\n\nExclusion Criteria:\n\n1. No known additional diagnoses causal of developmental language disorder including\n\n   1. autism spectrum disorder\n   2. hearing loss\n   3. severe intellectual disability\n2. Is not attending or has completed Kindergarten",[89],"CHILD",[91,114],{"facility":92,"status":8,"city":93,"state":94,"zip":95,"country":96,"contacts":97,"geoPoint":111},"Schoenbaum Family Center; Crane Center for Early Childhood Research and Policy","Columbus","Ohio","43201","United States",[98,103,106,109],{"name":99,"role":100,"phone":101,"email":102},"Jennifer M Bostic, MA","CONTACT","614-292-5715","bostic.18@osu.edu",{"name":104,"role":105},"Laura M Justice, PhD","PRINCIPAL_INVESTIGATOR",{"name":107,"role":108},"Rebecca Dore, PhD","SUB_INVESTIGATOR",{"name":110,"role":108},"Hui Jiang, PhD",{"lat":112,"lon":113},39.96118,-82.99879,{"facility":115,"status":8,"city":93,"state":94,"zip":116,"country":96,"contacts":117,"geoPoint":124},"Nationwide Children's Hospital","43205",[118,122],{"name":119,"role":100,"phone":120,"email":121},"Jamie B Boster, PhD","614-722-8756","jamie.boster@nationwidechildrens.org",{"name":123,"role":105},"Jamie B Boster, PhD, CCC-SLP",{"lat":112,"lon":113},[126,127],{"name":99,"role":100,"phone":101,"email":102},{"name":104,"role":100,"phone":128,"email":129},"614-292-1045","justice.57@osu.edu",[131],{"name":104,"affiliation":13,"role":105},[],[],{"nct_id":4,"conditions":135,"biomarkers":138},[136,137],"Developmental language disorder","Difficulty reading",[],{"nct_id":4,"found":140,"summary":141,"prompt_version":150},true,{"design":142,"status":143,"heading":6,"summary":144,"follow_up":145,"word_count":146,"commitments":147,"compensation":148,"drugs_mentioned":149},"This is an interventional study planning to enroll 320 participants. Caregivers will be assigned to either a control group or one of three STAR groups.","completed","This study is looking at how a shared reading program called \"Sit Together and Read\" (STAR) helps children aged 4 to 5 with developmental language disorder (difficulty with language skills). It also explores how small monetary rewards or encouraging text messages can help caregivers use the STAR program regularly. The study wants to see how STAR affects children's reading skills both right after the program and up to two years later. You might be able to join if your child is 4 or 5 years old, is receiving or waiting for speech services, has language difficulties, and primarily communicates in English. The study will measure changes in your child's word and print awareness, alphabet knowledge, and name writing to see if the program is successful. The current status of this study is unclear.","The study aims to answer how much STAR impacts children's literacy skills in the short-term and long-term, up to two years after completing STAR.",133,"Not specified in the trial record.","Caregivers may receive a monetary reward of $0.50 for each session logged (up to 60 sessions) and audio-recording completed (up to 15 audio recordings).",[47],"v2"]