[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06139874":3,"trial-entities:NCT06139874":103,"trial-summary:NCT06139874":107},{"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":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":45,"secondary_outcomes":50,"sex":65,"minimum_age":66,"maximum_age":67,"healthy_volunteers":15,"eligibility_criteria":68,"std_ages":77,"locations":79,"central_contacts":89,"overall_officials":90,"references":94,"see_also_links":99},"NCT06139874","202306092","Thrive Intervention in Schools","Promoting Emotional Development Among Young Children Facing Adversity: An Effectiveness Implementation Study in St. Louis Schools","ENROLLING_BY_INVITATION","2028-11-10","2026-03","2026-03-12","2024-08-09","Washington University School of Medicine","OTHER",false,"This study is designed to test the effectiveness and implementation of an early intervention therapy for children and their primary caregivers by using existing school counselors across several school districts.\n\nThe intervention is a 6-8 week caregiver-child intervention (THRIVE) which will be conducted via video conference in the family's home (i.e., zoom), or within the school setting (or a combination of those 2 modalities depending upon feasibility for the family). THRIVE will be compared to an asynchronous on-line parenting education program, Parenting Wisely (PW). This online parenting course will be accessed at www.parentingwisely.com.\n\nExisting school counselors will be trained in the delivery of THRIVE to 3-7 year old children (in preschool, kindergarten and first grade) and their primary caregivers. In addition to testing the effectiveness of THRIVE compared to PW, we will also compare two implementation strategies: THRIVE-Coached and THRIVE-Low Coached (LC). We will assess ongoing coaching of THRIVE trainees to increase therapist efficacy and adherence to the intervention (THRIVE-Coached). This will be compared to implementation of THRIVE with low supports (e.g. weekly supervision) provided only for the first case following the initial training (THRIVE-LC\\].\n\nCompared to those randomized to PW, we expect children who receive THRIVE will have significantly better behavioral and socio-emotional outcomes. Caregivers who receive THRIVE will experience less parenting stress and depression, more optimism and will show more nurturing, emotional tolerance, and supportive caregiving.\n\nTherapists in the THRIVE-Coached condition will deliver the intervention with higher achieved outcomes and find the intervention to be more acceptable than therapists in the THRIVE-LC condition. Therapists in the THRIVE-Coached condition will be more likely to plan to sustain the intervention following the completion of the study than those in the THRIVE-LC condition. Parents and children receiving THRIVE from therapists in the THRIVE-Coached condition will have better socio-emotional outcomes than those in the THRIVE-LC and PW conditions.",null,[19],"Childhood Mental Disorder",[21,22,23,24,25],"Preschool","Parent-Child Relationship","Emotion Development","Therapy","Prevention","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},405,"ESTIMATED",[34,41],{"type":35,"name":36,"description":37,"armGroupLabels":38},"BEHAVIORAL","THRIVE","Early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention.",[39,40],"THRIVE Coached","THRIVE Low Coached",{"type":35,"name":42,"description":43,"armGroupLabels":44},"Parenting Wisely","Online asynchronous parenting program.",[42],[46],{"measure":47,"description":48,"timeFrame":49},"Child Behavior Checklist","Measure of child psychopathology\u002Fimpairment (emotional and behavioral functioning). Raw scores are converted into T-scores. The T-scores range from 50 to 100, with higher scores indicating more problematic behaviors. T-scores above 65 indicate psychiatric symptoms.","T1 (baseline), T2 (halfway through intervention), T3 (completion of intervention) and T4 (12 weeks post intervention)",[51,55,59,62],{"measure":52,"description":53,"timeFrame":54},"The Emotion Regulation Checklist","Measure of children's self-regulation that targets affective lability, intensity, valence, and flexibility. The total scores range from 24 to 96, with higher scores indicating better emotion regulation.","T1 (baseline), T3 (completion of intervention)",{"measure":56,"description":57,"timeFrame":58},"Coping with Children's Negative Emotions Scale","Measure of parental coping styles in response to children's negative emotions. It consists of six subscales: Distress Reactions, Punitive Reactions, Expressive Encouragement, Emotion-Focused Reactions, Problem-Focused Reactions, and Minimization Reactions. The scores of each subscale range from 12 to 84, with higher scores indicating a greater likelihood of the parent engaging the type of response measured by that subscale.","T1 (baseline), T2 (halfway through intervention), T3 (completion of intervention)",{"measure":60,"description":61,"timeFrame":54},"Parenting Stress Index","Measure of potential dysfunctional parent-child relationships and severity of parenting stress. Higher scores indicate higher levels of stress.",{"measure":63,"description":64,"timeFrame":54},"Parent-Child Observed Interaction Coding","Objective ratings of the parent-child relationship functioning, parent emotion learning and child emotional competence.","ALL","3 Years","7 Years",{"inclusion":69,"exclusion":72,"raw_text":76},[70,71],"Near the clinical threshold on the Teacher or Parent Report Form","An active primary caregiver can be identified and is available to participate in the intervention (mother, father, grandparent or any adult in this role)",[73,74,75],"Autism","Major neurological disorder","Participating in active weekly individual or family therapy","Inclusion Criteria:\n\n* Near the clinical threshold on the Teacher or Parent Report Form\n* An active primary caregiver can be identified and is available to participate in the intervention (mother, father, grandparent or any adult in this role)\n\nExclusion Criteria:\n\n* Autism\n* Major neurological disorder\n* Participating in active weekly individual or family therapy",[78],"CHILD",[80],{"facility":81,"city":82,"state":83,"zip":84,"country":85,"geoPoint":86},"Early Emotional Development Program","St Louis","Missouri","63108","United States",{"lat":87,"lon":88},38.62727,-90.19789,[],[91],{"name":92,"affiliation":13,"role":93},"Joan Luby, PhD","PRINCIPAL_INVESTIGATOR",[95],{"pmid":96,"type":97,"citation":98},"42277967","DERIVED","Wang S, Quinones H, Miller L, Luby J, Kohl PL. Implementation climate and readiness for the THRIVE intervention in school settings: a mixed methods study. Implement Sci Commun. 2026 Jun 11. doi: 10.1186\u002Fs43058-026-01006-w. Online ahead of print.",[100],{"label":101,"url":102},"Early Emotional Development Program Website","http:\u002F\u002Feedp.wustl.edu\u002F",{"nct_id":4,"conditions":104,"biomarkers":106},[105],"Pediatric Psychiatric Disorder",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]