[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656905":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":36,"studyPopulation":36,"armGroups":46,"interventions":55,"overallOfficials":36,"centralContacts":61,"locations":36,"responsibleParty":67,"collaborators":71,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":36,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":36,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":101,"whyStopped":36,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":36},{"fullName":5,"class":6},"Children's National Research Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Early Childhood Behavior Observation of Classroom Function (EC-BOCEF)","Masked classroom observation of child executive function behaviors. Each behavior is rated as 0 or 1 (0 =no problem, 1 = problem). The scores on 7 behaviors are summed to a total score.","From enrollment to end of treatment (8-20 weeks)",[14,18,21,24,27,30,33],{"measure":15,"description":16,"timeFrame":17},"Observation of Teacher Executive Function-Supporting Strategies (OTESS)","Masked observation of teacher use of executive function supporting strategies in the classroom. The observer counts each instance of strategy use and sums these to a total score.","Enrollment to end of intervention (8-20 weeks)",{"measure":19,"description":20,"timeFrame":17},"Child Behavior Rating Scale","Informant rating of child classroom behaviors. Each item is rated on a 1-5 Likert scale (higher scores = more prosocial\u002Fpositive behavior) and summed to a total score.",{"measure":22,"description":23,"timeFrame":17},"Behavior Rating Inventory of Executive Function","Informant rating of child executive function. Each behavior is rated on a Likert scale (0, 1, 2) and total scores are generated as age-normed T-scores where higher scores indicate greater executive function challenges",{"measure":25,"description":26,"timeFrame":17},"Differential Ability Scales-II: Pattern Construction","Direct measure of visual-spatial problem-solving that taps executive function. Total scores are converted to age-normed T-scores, where higher scores indicate better abilities.",{"measure":28,"description":29,"timeFrame":17},"Teacher Executive Function Classroom Knowledge Survey","Assessment of teachers' knowledge of executive function, using multiple choice. Higher total scores indicate more knowledge of executive function.",{"measure":31,"description":32,"timeFrame":17},"Unstuck-EC Knowledge Survey","Multiple choice assessment of teacher knowledge of intervention strategies. Higher scores indicate greater knowledge.",{"measure":34,"description":35,"timeFrame":17},"Unstuck-EC Self-Reported Strategy Use Survey","Teacher report of their own use of Unstuck-EC strategies. Higher scores indicate more use of of Unstuck-EC strategies.",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":40,"primaryPurpose":41,"observationalModel":36,"timePerspective":36,"maskingInfo":42},"RANDOMIZED","CROSSOVER","Data collection will occur over 2 years. A waitlist control at the school level will be used. Participating schools will be randomized to either Intervention (Unstuck-EC) or Services-As-Usual Control. Schools assigned to Intervention in Year 1 will not participate in Year 2. School assigned to Services as Usual in Year 2 will be assigned to Intervention in Year 2. New schools enrolled in Year 2 will be assigned to Services as Usual and will have access to the intervention after data collection is complete.","TREATMENT",{"masking":43,"maskingDescription":36,"whoMasked":44},"SINGLE",[45],"OUTCOMES_ASSESSOR",[47,52],{"label":48,"type":49,"description":36,"interventionNames":50},"Unstuck-EC","EXPERIMENTAL",[51],"Behavioral: Unstuck and On Target for Early Childhood",{"label":53,"type":54,"description":36,"interventionNames":36},"Services as Usual","NO_INTERVENTION",[56],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":36},"BEHAVIORAL","Unstuck and On Target for Early Childhood","Unstuck and On Target for Early Childhood is a cognitive-behavioral Tier 2 (selective) intervention for young children with executive function deficits. It consists of 16 sessions (\\~20 minutes) delivered 1-2 times weekly. It crates a common language of self-regulatory vocabulary used across schools and families to teach children skills for making plans and thinking flexibly. It uses storybooks, music, and play, in school-delivered sessions, to build child executive function skills. It is accompanied by parent education, delivered in brief updates following each session, as well as instructional videos.",[48],[62],{"name":63,"role":64,"phone":65,"phoneExt":36,"email":66},"Allison B Ratto, PhD","CONTACT","301-765-5596","aratto@childrensnational.org",{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"PRINCIPAL_INVESTIGATOR","Allison Ratto","Psychologist and Associate Professor",[72,75,77],{"name":73,"class":74},"National Institute of Mental Health (NIMH)","NIH",{"name":76,"class":6},"University of Colorado, Denver",{"name":78,"class":6},"University of Oregon","100656905","unstuck-early-childhood-effectiveness--implementation-trial-100656905",false,"NCT07832344","Unstuck-Early Childhood Effectiveness & Implementation Trial","Changing Developmental Trajectories Through Early Executive Function Intervention in Early Childhood Education","Inclusion Criteria:\n\n1. Age 4-5 years at time of enrollment\n2. Enrolled in a participating publicly funded preschool program and eligible for special education services through an Individualized Education Program (IEP), in a classroom placement that includes children who can communicate using verbal speech\n3. Ability to speak in at least short sentences and answer simple questions about removed contexts (e.g., events that occurred earlier that day) in English\n4. Identified by school staff as having executive function challenges, on basis of written description of sample behaviors and nomination to study participation by school staff\u002Fteachers\n5. Intact or corrected-to-normal hearing and vision\n6. The parents speak and read English or Spanish with sufficient fluency for completion of consent forms and informant questionnaires, as well as understanding family educational materials.\n\nExclusion Criteria:\n\n1. No longer enrolled at a participating school site\n2. Insufficient English fluency or language skills to complete intervention\n3. Sensory, neurological, developmental, or other impairment that would prevent the child from participating in the intervention and\u002For completing study measures","ALL","4 Years","5 Years",{"count":90,"type":91},90,"ESTIMATED","INTERVENTIONAL",[94],"NA","The goal of this clinical trial is to learn if a new school-based, Tier 2 (selective) cognitive-behavioral intervention called Unstuck and On Target for Early Childhood (Unstuck-EC) can treat executive function deficits in young children (ages 4-5). Executive function is a critical set of cognitive abilities that enable individuals to demonstrate skills, effectively complete tsks, and navigate social interactions through flexible regulation of their thinking, behavior, and emotions. All children will be receiving special education services and be identified by their classroom teachers as having problems with flexibility and\u002For emotion regulation. Unstuck-EC consists of 16 sessions, each lasting about 20 minutes, delivered 1-2 times per week. Unstuck-EC will be adapted in this trial to be delivered by classroom teachers. The main questions it aims to answer are:\n\n1. Do special education preschool teachers find Unstuck-EC to be feasible, appropriate, and acceptable for use in their classrooms?\n2. Do special education preschool teachers trained in Unstuck-EC better understand and support executive function in the classroom?\n3. Does Unstuck-EC improve children's executive function skills?\n\nResearchers will compare Unstuck-EC (N=45 participants) to a \"services as usual\" control (N=45 participants). This means that all children will receive usual services at school through their Individualized Education Plan and associated special education supports. Those in Unstuck-EC will also receive the intervention.\n\nParticipants in both groups will be followed for the same period of time (minimum of 8 weeks). All child participants will complete a baseline assessment, which include language testing for eligibility, as well as a classroom observation and direct testing of cognitive flexibility. Additionally, parents and case managers will complete behavioral rating scales of children's executive function skills and classroom behavior. All measures will be collected again at the end of the intervention period, with the exception of language testing. Additional measures will also be completed by the teacher to examine knowledge of executive function and use of Unstuck-EC strategies and executive-function supporting strategies. Teachers will also report on their own stress and self-efficacy and will complete ratings of child expulsion risk.\n\nParticipants will \\[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\\].",[97],"Executive Function Deficits (EFD)",[99,100],"Cognitive Behavioral Therapy","Developmental Disabilities","NOT_YET_RECRUITING","2026-09-16",{"date":104,"type":105},"2026-09-21","ACTUAL",{"date":107,"type":91},"2027-08",{"date":109,"type":91},"2029-04",{"name":5,"class":6}]