An interventional study of App-based Compassion Program in Physiological Conditions, Distress, Emotional and Caregiving Stress, sponsored by University of Aarhus. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by University of Aarhus · Not applicable, Interventional, and Supportive care
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.
The 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.
Sub-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.
500 studies on the registry are indexed under Caregiver Burden; 164 are open to participants now.
This study's planned enrollment of 400 is above the median of 71 across 402 interventional studies indexed under Caregiver Burden.
Browse Caregiver Burden studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Sub-study 1
Sub-study 2
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Time frame: Measured at end of treatment (approximately Week 4)
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.
Time frame: Measured at baseline, mid-treatment (approximately Day 14), end of treatment (approximately Week 4), and at 3 months follow up.
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.
Time frame: Measured at baseline, mid-treatment (approximately Day 14), end of treatment (approximately Week 4), and at 3 months follow up.
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
Time frame: Measured at baseline, mid-treatment (approximately Day 14), end of treatment (approximately Week 4), and at 3 months follow up.
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.
Time frame: Measured at baseline, mid-treatment (approximately Day 14), end of treatment (approximately Week 4), and at 3 months follow up.
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.
Time frame: Measured at baseline, mid-treatment (approximately Day 14), end of treatment (approximately Week 4), and at 3 months follow up.
Forms of Self-Criticizing/Attacking 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/or self-reassurance depending on the subscale.
Time frame: Measured at baseline, mid-treatment (approximately Day 14), end of treatment (approximately Week 4), and at 3 months follow up.
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.
Time frame: Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.
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.
Time frame: Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.
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.
Time frame: Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.
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.
Time frame: Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.
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.
Time frame: Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.
EuroQol Five Dimensions (ED-Q5)
The scale measures health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 5-point scale (1=no problems, 5=extreme problems/unable 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).
Time frame: Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.
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/inattention, 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.
Time frame: Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.
Adverse Events Mini-Screen
The 6-item scale measures adverse events following use of the intervention. Four items assess, using a yes/no 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.
Time frame: Measured at end of intervention (approximately Week 4)
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be made publicly available due to data protection and privacy considerations. Anonymized data may be made available upon reasonable request to the investigators, subject to applicable data protection regulations and necessary approvals.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.