[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653739":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":64,"studyPopulation":64,"armGroups":68,"interventions":75,"overallOfficials":80,"centralContacts":84,"locations":92,"responsibleParty":119,"collaborators":122,"id":124,"slug":125,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":128,"acronym":64,"eligibilityCriteria":129,"healthyVolunteers":126,"sex":130,"minAge":131,"maxAge":64,"enrollmentInfo":132,"targetDuration":64,"studyType":135,"phases":136,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":145,"whyStopped":64,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"Florida Atlantic University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":44},[9,13],{"measure":10,"description":11,"timeFrame":12},"Child's Stress Symptoms","Presence and severity of stress symptoms will be assessed (parent-reported) using the Young Child PTSD Checklist (YCPC). The 30-item scale yields a sum score ranging from 0 to 120, with higher scores indicating more severe stress symptoms.","8 weeks",{"measure":14,"description":15,"timeFrame":12},"Child's Sleep Quality","The child's sleep quality will be assessed (parent-reported) using the Children's Sleep Habits Questionnaire Abbreviated (CSHQ). The 22-item scale yields a sum score ranging from 0 to 88, with higher scores indicating more severe sleep problems.",[17,20,23,26,29,32,35,38,41],{"measure":18,"description":19,"timeFrame":12},"Child-Parent Relationship: Closeness","The quality of the child-parent relationship will be assessed (parent-reported) using the Child-Parent Relationship Scale - Short Form (CPRS-SF), specifically the Closeness subscale. The 7-item subscale yields a sum score of 7 to 35, with higher scores indicating greater closeness. Higher closeness scores reflect better relationship between the child and the parent.",{"measure":21,"description":22,"timeFrame":12},"Child-Parent Relationship: Conflict","The quality of the child-parent relationship will be assessed (parent-reported) using the Child-Parent Relationship Scale - Short Form (CPRS-SF), specifically the Conflict subscale. The 8-item subscale yields a sum score of 8 to 40, with higher scores indicating greater conflict. Lower conflict scores reflect better relationship between the child and the parent.",{"measure":24,"description":25,"timeFrame":12},"Parent's Stress Symptoms","Presence and severity of post-traumatic stress symptoms will be assessed (self-reported) using the PCL-5 scale. The 20-item scale yields a sum score ranging from 0 to 80, with higher scores indicating more severe post-traumatic stress symptoms.",{"measure":27,"description":28,"timeFrame":12},"Parent's Sleep Quality","The parent's sleep quality will be assessed (self-reported) using the Sleep Disturbance PROMIS SF 8b. The 8-item scale yields a sum score ranging from 8 to 40, with higher scores indicating more severe sleep problems.",{"measure":30,"description":31,"timeFrame":12},"Parental Self-Efficacy","The parent's self-confidence in their ability to handle their child's behavior problems will be assessed (self-reported) by the Brief Parental Self-Efficacy Scale. The 5-item scale yields a sum score ranging from 5 to 20, with higher scores indicating greater self-confidence.",{"measure":33,"description":34,"timeFrame":12},"Child's Pain Severity","If the child experiences pain, pain severity will be assessed (parent-reported) using one item from the Brief Pain Inventory (BPI). Pain severity will be rated on a scale from 0 to 10, with higher rating indicating more severe pain.",{"measure":36,"description":37,"timeFrame":12},"Child's Pain Interference","If the child experiences pain, pain interference with routine activities will be assessed (parent-reported) using one item from the Brief Pain Inventory (BPI). The level of how much the pain interferes with routine activities will be rated on a scale from 0 to 10, with higher ratings indicating greater interference.",{"measure":39,"description":40,"timeFrame":12},"Parent's Pain Severity","If the parent experiences pain, pain severity will be assessed (self-reported) using one item from the Brief Pain Inventory (BPI). Pain severity will be rated on a scale from 0 to 10, with higher rating indicating more severe pain.",{"measure":42,"description":43,"timeFrame":12},"Parent's Pain Interference","If the parent experiences pain, pain interference will be assessed (self-reported) using two items from the Brief Pain Inventory (BPI). The level of how much the pain interferes with (a) enjoyment in life and with (b) routine activities will be rated on a scale from 0 to 10, with higher ratings indicating greater interference.",[45,49,52,55,58],{"measure":46,"description":47,"timeFrame":48},"Feasibility: Recruitment","Recruitment will be calculated as the proportion of enrolled participants to interested individuals during the recruitment period.","Recruitment period, from initiation until the start day of the intervention",{"measure":50,"description":51,"timeFrame":12},"Feasibility: Intervention Retention","Retention will be calculated as the proportion of participants who completed the intervention to participants who gave their consent to participate.",{"measure":53,"description":54,"timeFrame":12},"Feasibility: Intervention Adherence","Percentage of participants completing at least 75% of the group sessions AND at least 4 at-home practices per week. Group session attendance will be monitored by the research team. At-home practice will be self-reported via a daily practice log.",{"measure":56,"description":57,"timeFrame":12},"Acceptability: Liking","Parents will be asked if they liked the intervention on a scale of 0 to 10, with higher ratings indicating greater liking and better acceptability of the intervention among parents.",{"measure":59,"description":60,"timeFrame":12},"Acceptability: Recommending","Parents will be asked about the likelihood that they would recommend the program to others, rated from 0 to 100%, with higher ratings indicating a greater likelihood of recommending the intervention and better acceptability of the intervention among parents.",{"allocation":62,"interventionModel":63,"interventionModelDescription":64,"primaryPurpose":65,"observationalModel":64,"timePerspective":64,"maskingInfo":66},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":67,"maskingDescription":64,"whoMasked":64},"NONE",[69],{"label":70,"type":71,"description":72,"interventionNames":73},"Intervention","EXPERIMENTAL","Dyadic (Child-Parent) Yoga",[74],"Behavioral: Dyadic (Child-Parent) Yoga",[76],{"type":77,"name":72,"description":78,"armGroupLabels":79,"otherNames":64},"BEHAVIORAL","Participants will attend 8 weekly group sessions of dyadic (child and parent) yoga and engage in at-home practice at bedtime.",[70],[81],{"name":82,"affiliation":5,"role":83},"Shahar Almog, PhD","PRINCIPAL_INVESTIGATOR",[85,89],{"name":82,"role":86,"phone":87,"phoneExt":64,"email":88},"CONTACT","+1 (561) 2973461","salmog@fau.edu",{"name":90,"role":86,"phone":64,"phoneExt":64,"email":91},"Noga Tsur, PhD","nogatsur@tauex.tau.ac.il",[93,105],{"facility":5,"status":64,"city":94,"state":95,"zip":96,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":104,"contacts":64},"Boca Raton","Florida","33431","United States","US",{"type":100,"coordinates":101},"Point",[102,103],-80.0831,26.35869,{"lat":103,"lon":102},{"facility":106,"status":64,"city":107,"state":64,"zip":64,"country":108,"countryCode":109,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Tel Aviv University","Tel Aviv","Israel","IL",{"type":100,"coordinates":111},[112,113],34.78057,32.08088,{"lat":113,"lon":112},[116,118],{"name":90,"role":86,"phone":117,"phoneExt":64,"email":91},"0000000000",{"name":90,"role":83,"phone":64,"phoneExt":64,"email":64},{"type":83,"investigatorFullName":120,"investigatorTitle":121,"investigatorAffiliation":5,"oldNameTitle":64,"oldOrganization":64},"Shahar Almog","Senior Research Fellow",[123],{"name":106,"class":6},"100653739","project-leo-trauma-informed-yoga-for-preschool-children-and-parents-100653739",false,"NCT07790588","Project Leo: Trauma-Informed Yoga for Preschool Children and Parents","Inclusion Criteria:\n\nChildren: Age 3-6. Per the parent's report, the child exhibits at least one stress-related symptom.\n\nParents: Preferably, the same parent can attend all group sessions. Having internet access at home to complete online surveys.\n\nExclusion Criteria:\n\nChildren: Any physical disability that prevents participating safely in yoga sessions.\n\nParents: Self-reported pregnancy. Any physical disability that prevents participating safely in gentle yoga sessions.","ALL","3 Years",{"count":133,"type":134},66,"ESTIMATED","INTERVENTIONAL",[62],"The goal of this pilot clinical trial is to examine feasibility, acceptability, and direction of effect of a dyadic (child and parent) trauma-informed yoga intervention on stress symptoms and sleep in young children (age 3-6) after war. The main questions it aims to answer are:\n\n* Is the intervention feasible and liked by the participants?\n* Does the child-parent yoga intervention reduce the child's stress symptoms and improve their sleep?\n* Does the child-parent yoga intervention improve the child-parent relationship?\n\nParticipants (child-parent dyads) will:\n\n* Children and parents will participate together in 8 weekly group yoga sessions.\n* Children and parents will engage together in a short daily at-home practice before bedtime.\n* Parents will complete online surveys before and after the 8-week program, and at one-month follow-up.\n* Parents will complete a daily practice-sleep log.",[139],"Post Traumatic Concerns",[141,142,143,144],"Post-trauma","Children","Yoga","Child-Parent Dyad","NOT_YET_RECRUITING","2026-08-26",{"date":148,"type":149},"2026-08-27","ACTUAL",{"date":151,"type":134},"2026-10-05",{"date":153,"type":134},"2027-03",{"name":5,"class":6},2]