[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657609":3},{"organization":4,"outcomesModule":7,"designInfo":60,"detailedDescription":59,"studyPopulation":59,"armGroups":66,"interventions":73,"overallOfficials":79,"centralContacts":84,"locations":59,"responsibleParty":94,"collaborators":96,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":59,"eligibilityCriteria":105,"healthyVolunteers":106,"sex":107,"minAge":108,"maxAge":59,"enrollmentInfo":109,"targetDuration":59,"studyType":112,"phases":113,"briefSummary":114,"conditions":115,"keywords":123,"overallStatus":126,"whyStopped":59,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":59},{"fullName":5,"class":6},"University of Aarhus","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":59},[9,13,17,20],{"measure":10,"description":11,"timeFrame":12},"Twente Engagement with Ehealth Technologies Scale (TWEETS)","The 9-item scale measures participants' engagement with the intervention, including integration into daily routines, perceived usefulness, motivation, enjoyment, self-insight, and perceived fit. Items are rated on a 5-point Likert scale (0=strongly disagree, 4=strongly agree), with 3 items assessing behavioral engagement, 3 assessing cognitive engagement, and 3 assessing affective engagement. Higher scores indicate greater engagement.","Measured at end of treatment (approximately Week 4)",{"measure":14,"description":15,"timeFrame":16},"Parental Burnout Assessment Scale (PBA)","The 23-item scale measures parental burnout across four dimensions, including exhaustion in the parenting role, contrast with previous parental self, feelings of being fed up with parenting, and emotional distancing from one's child. Items are rated on a 5-point Likert scale (1=never, 5=always), with 9 items assessing exhaustion in the parenting role, 6 items assessing contrast with previous parental self, 5 items assessing feelings of being fed up with parenting, and 3 items assessing emotional distancing from one's child. Higher scores indicate greater parental burnout.","Measured at baseline, mid-treatment (approximately Day 14), end of treatment (approximately Week 4), and at 3 months follow up.",{"measure":18,"description":19,"timeFrame":16},"Three Circles Digital Scale","The digital scale measures the relative activation of the threat, drive, and soothing emotional regulation systems. Participants adjust the size of three circles to indicate perceived activation, with larger circles indicating greater activation of the respective system.",{"measure":21,"description":22,"timeFrame":16},"Family Empowerment Scale (FES)","The 12-item Family subscale of the Family Empowerment Scale measures parents' confidence in supporting their child, managing family challenges, accessing support and information, understanding their child's difficulties, and effectively addressing parenting-related problems. Items are rated on a 5-point Likert scale (1=never, 5=very often). Higher scores indicate greater parental empowerment",[24,27,30,33,37,40,43,46,49,52,55],{"measure":25,"description":26,"timeFrame":16},"The Self-Compassion Scale Short Form (SCS-SF)","The 12-item scale measures self-compassion across six components: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. Items are rated on a 5-point Likert scale (1=almost never, 5=almost always). Higher scores indicate greater self-compassion.",{"measure":28,"description":29,"timeFrame":16},"Compassionate Parent","The single-item scale, based on social identity theory, measures the extent to which parents have responded to their child with compassion, kindness, understanding, and support during difficult situations over the past 7 days. Participants rate this on a scale from 0 (not at all) to 100 (to a very high degree), with higher scores indicating greater compassionate parenting.",{"measure":31,"description":32,"timeFrame":16},"Forms of Self-Criticizing\u002FAttacking and Self-Reassuring Scale (FSCRS)","The 22-item scale measures self-critical and self-reassuring responses to setbacks, mistakes, and perceived inadequacies across three subscales: Inadequate Self, Hated Self, and Reassure Self. Items are rated on a 5-point Likert scale (0=not at all like me, 4=extremely like me), with higher scores indicating greater self-criticism and\u002For self-reassurance depending on the subscale.",{"measure":34,"description":35,"timeFrame":36},"Other As Shamer Scale-2 (OAS-2)","The 8-item scale measures perceptions of being negatively judged, evaluated, or viewed by others (external shame). Items are rated on a 5-point Likert scale (0=never, 4=almost always), with higher scores indicating greater external shame.","Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.",{"measure":38,"description":39,"timeFrame":36},"Difficulties in Emotion Regulation Scale (DERS-16)","The 16-item scale measures difficulties in understanding, accepting, and managing emotions, as well as difficulties maintaining goal-directed behavior and controlling impulses during emotional distress, including nonacceptance of negative emotions, inability to engage in goal-directed behaviors when distressed, difficulties controlling impulsive behaviors when distressed, limited access to emotion regulation strategies, and lack of emotional clarity. Items are rated on a 5-point Likert scale (1=almost never, 5=almost always), with higher scores indicating greater difficulties in emotion regulation.",{"measure":41,"description":42,"timeFrame":36},"Patient Health Questionnaire (PHQ-9)","The 9-item scale measures the frequency and severity of depressive symptoms experienced over the past two weeks. Items are rated on a 4-point Likert scale (0=not at all, 3=nearly every day), with higher scores indicating greater depressive symptom severity.",{"measure":44,"description":45,"timeFrame":36},"Generalized Anxiety Disorder Scale (GAD-7)","The 7-item scale measures the frequency and severity of anxiety symptoms experienced over the past two weeks. Items are rated on a 4-point Likert scale (0=not at all, 3=nearly every day), with higher scores indicating greater anxiety symptom severity.",{"measure":47,"description":48,"timeFrame":36},"Oslo Social Support Scale (OSSS-3)","The 3-item scale measures perceived social support, including the availability of close relationships, interest and concern from others, and access to practical help from neighbors. Each item has its own response categories, and the total score is the sum of the three items, with higher scores indicating greater perceived social support.",{"measure":50,"description":51,"timeFrame":36},"EuroQol Five Dimensions (ED-Q5)","The scale measures health-related quality of life across five dimensions: mobility, self-care, usual activities, pain\u002Fdiscomfort, and anxiety\u002Fdepression. Each dimension is rated on a 5-point scale (1=no problems, 5=extreme problems\u002Funable to). The scale also includes a visual analogue scale (VAS) on which respondents rate their current health state from 0 (worst imaginable health state) to 100 (best imaginable health state).",{"measure":53,"description":54,"timeFrame":36},"Strengths and Difficulties Questionnaire (SDQ)","The 25-item scale plus 5-item impact scale, completed by parents, measures children's emotional symptoms, conduct problems, hyperactivity\u002Finattention, peer relationship problems, and prosocial behavior over the past six months, with 5 items per subscale. Items are rated on a 3-point Likert scale (0=not true, 1=somewhat true, 2=certainly true), with higher scores on the Total Difficulties Score indicating greater emotional and behavioral difficulties.",{"measure":56,"description":57,"timeFrame":58},"Adverse Events Mini-Screen","The 6-item scale measures adverse events following use of the intervention. Four items assess, using a yes\u002Fno format, whether participants experienced increased difficult emotions, distressing memories or thoughts, increased self-criticism or feelings of inadequacy, and reduced daily functioning. A fifth item assesses the perceived burden of these experiences on a 5-point scale (0=not at all, 4=extremely), and a sixth item assesses the extent to which participants attribute the experiences to the intervention (yes, partly, no, don't know). Higher scores and endorsement of adverse event items indicate greater negative effects associated with the intervention.","Measured at end of intervention (approximately Week 4)",null,{"allocation":61,"interventionModel":62,"interventionModelDescription":59,"primaryPurpose":63,"observationalModel":59,"timePerspective":59,"maskingInfo":64},"NA","SINGLE_GROUP","SUPPORTIVE_CARE",{"masking":65,"maskingDescription":59,"whoMasked":59},"NONE",[67],{"label":68,"type":69,"description":70,"interventionNames":71},"Participant Group","EXPERIMENTAL","All participants receive access to Hand in Hand, a self-guided compassion-focused app consisting of four sequential modules delivered over four weeks, with one new module becoming available each week. The intervention includes brief information, guided exercises, reflections, and audio and visual materials focusing on compassion, emotion regulation, and parental well-being. Participants are encouraged to engage with the app and practice the exercises regularly throughout the four-week intervention.",[72],"Behavioral: App-based Compassion Program",[74],{"type":75,"name":76,"description":77,"armGroupLabels":78,"otherNames":59},"BEHAVIORAL","App-based Compassion Program","The intervention Hand in Hand provides information, reflections, and practical exercises based on principles from Compassion Focused Therapy (CFT). Participants are introduced to strategies for understanding and regulating emotional responses, directing compassion toward themselves and others, and applying compassion in challenging situations in everyday life. The program includes guided exercises, audio and video materials, and brief daily reflections, with participants encouraged to practise the exercises regularly between sessions.",[68],[80],{"name":81,"affiliation":82,"role":83},"Karen H Kallesøe","Aarhus University Hospital, Department of Child and Adolescent Psychiatry and Aarhus University, Department of Clinical Medicine","PRINCIPAL_INVESTIGATOR",[85,90],{"name":86,"role":87,"phone":88,"phoneExt":59,"email":89},"Karen H Kallesøe, MD, PhD, Associate Professor","CONTACT","+4561619418","karekall@rm.dk",{"name":91,"role":87,"phone":92,"phoneExt":59,"email":93},"Emma N Tonsberg, MSc","+4551349057","EMTONS@rm.dk",{"type":95,"investigatorFullName":59,"investigatorTitle":59,"investigatorAffiliation":59,"oldNameTitle":59,"oldOrganization":59},"SPONSOR",[97],{"name":98,"class":6},"Aarhus University Hospital","100657609","hand-in-hand-feasibility-of-a-compassion-focused-app-to-support-parents-of-children-with-mental-health-problems-100657609",false,"NCT07840404","Hand in Hand: Feasibility of a Compassion-Focused App to Support Parents of Children With Mental Health Problems","Hand in Hand - Supporting Parents of Children With Mental Health Problems Referred to Hospital Care - Preliminary Testing of a Compassion Focused App-intervention Co-designed With-end Users","Inclusion Criteria:\n\nSub-study 1\n\n* Parents of a child or adolescent referred to CAMHS in Central Denmark Region (eligible parents will be identified from waitlists of referred children or adolescents)\n* Reads, speaks and understands Danish\n* Access to a smartphone or tablet\n\nSub-study 2\n\n* Completed all four modules of the Hand in Hand intervention\n* Have provided informed consent to be contacted after completion.\n\nExclusion Criteria:\n\n* No specific exclusion criteria",true,"ALL","18 Years",{"count":110,"type":111},400,"ESTIMATED","INTERVENTIONAL",[61],"Parents of children and adolescents with mental health problems may experience substantial caregiving burden and emotional distress, including persistent stress, self-criticism, shame, and parental burnout. Hand in Hand is a four-week, self-guided, compassion-focused app developed to support parents of children and adolescents referred to Child and Adolescent Mental Health Services (CAMHS). Drawing on principles from Compassion Focused Therapy (CFT) and inspired by work by Kirby et al., the app was developed through a participatory co-design process involving parents and clinical and research experts.\n\nThe project comprises two interrelated sub-studies. Sub-study 1 is an open feasibility study evaluating the feasibility and preliminary outcomes of Hand in Hand among parents of children and adolescents referred to CAMHS in the Central Denmark Region. Feasibility outcomes include recruitment, retention, adherence, engagement, acceptability, and data completeness. Preliminary changes in parental outcomes, including parental burnout, emotion regulation, family empowerment, self-compassion, self-criticism, shame, and emotional distress, as well as parent-reported child outcomes, will also be explored.\n\nSub-study 2 is an embedded qualitative study exploring parents' experiences of using Hand in Hand and their perceptions of whether and how the intervention influences parental well-being and family interactions.",[116,117,118,119,120,121,122],"Physiological Conditions","Distress, Emotional","Caregiving Stress","Burnout","Parental Burnout","App Engagement","Compassion",[118,117,124,125],"Parental burnout","Compassion focused therapy","NOT_YET_RECRUITING","2026-09-18",{"date":129,"type":130},"2026-09-25","ACTUAL",{"date":132,"type":111},"2026-11-01",{"date":134,"type":111},"2027-04-01",{"name":5,"class":6}]