Physiological ConditionsNCT07840404
Hand in Hand: Feasibility of a Compassion-Focused App to Support Parents of Children With Mental Health Problems
A study testing App-based Compassion Program in people with Physiological Conditions and Distress, Emotional, run by University of Aarhus.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physiological Conditions, Distress, Emotional, Caregiving Stress
- What is being tested?
- App-based Compassion Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sub-study 1
- 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)
- Reads, speaks and understands Danish
- Access to a smartphone or tablet
- Sub-study 2
- Completed all four modules of the Hand in Hand intervention
- Have provided informed consent to be contacted after completion.
Who cannot join
- No specific exclusion criteria
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
- Conditions
- Physiological Conditions, Distress, Emotional, Caregiving Stress, Burnout, Parental Burnout, App Engagement
- Being tested
- App-based Compassion Program
- Keywords
- Caregiving Stress, Distress, Emotional, Parental burnout, Compassion focused therapy
- Medical subject headings
- Caregiver Burden, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-based Compassion ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: App-based Compassion Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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.
Measured: 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.
Measured: 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
Measured: Measured at baseline, mid-treatment (approximately Day 14), end of treatment (approximately Week 4), and at 3 months follow up.
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Measured at end of intervention (approximately Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physiological ConditionsStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Karen H Kallesøe, Principal investigator, Aarhus University Hospital, Department of Child and Adolescent Psychiatry and Aarhus University, Department of Clinical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840404
- Sponsor's protocol ID
- 1-10-72-28-26
- Status last verified
- Nov 2026
- First submitted
- 18 Sep 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Kirby JN, Hoang A, Ramos N. A brief compassion focused therapy intervention can help self-critical parents and their children: A randomised controlled trial. Psychol Psychother. 2023 Sep;96(3):608-626. doi: 10.1111/papt.12459. Epub 2023 Mar 9.
PubMed 36892093
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07840404
- Acronym / sponsor ID
- 1-10-72-28-26
- Conditions
- Physiological Conditions, Distress, Emotional, Caregiving Stress, Burnout, Parental Burnout, App Engagement
- Keywords
- Caregiving Stress, Distress, Emotional, Parental burnout, Compassion focused therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant Group | Experimental | Behavioral: App-based Compassion ProgramAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Sub-study 1
- 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)
- Reads, speaks and understands Danish
- Access to a smartphone or tablet
- Sub-study 2
Key exclusion criteria (1 listed)
- No specific exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App-based Compassion ProgramThe 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. | Behavioural | Participant Group |
Primary outcome
Twente Engagement with Ehealth Technologies Scale (TWEETS)
Time frame: Measured at end of treatment (approximately Week 4)
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.
Parental Burnout Assessment Scale (PBA)
Time frame: Measured at baseline, mid-treatment (approximately Day 14), end of treatment (approximately Week 4), and at 3 months follow up.
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.
Three Circles Digital Scale
Time frame: Measured at baseline, mid-treatment (approximately Day 14), end of treatment (approximately Week 4), and at 3 months follow up.
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.
Family Empowerment Scale (FES)
Time frame: Measured at baseline, mid-treatment (approximately Day 14), end of treatment (approximately Week 4), and at 3 months follow up.
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
11 secondary outcomes
The Self-Compassion Scale Short Form (SCS-SF)
Time frame: Measured at baseline, mid-treatment (approximately Day 14), end of treatment (approximately Week 4), and at 3 months follow up.
Compassionate Parent
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)
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)
Time frame: Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.
Difficulties in Emotion Regulation Scale (DERS-16)
Time frame: Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.
Patient Health Questionnaire (PHQ-9)
Time frame: Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.
Generalized Anxiety Disorder Scale (GAD-7)
Time frame: Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.
Oslo Social Support Scale (OSSS-3)
Time frame: Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.
EuroQol Five Dimensions (ED-Q5)
Time frame: Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.
Strengths and Difficulties Questionnaire (SDQ)
Time frame: Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.
Adverse Events Mini-Screen
Time frame: Measured at end of intervention (approximately Week 4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 36892093Kirby JN, Hoang A, Ramos N. A brief compassion focused therapy intervention can help self-critical parents and their children: A randomised controlled trial. Psychol Psychother. 2023 Sep;96(3):608-626. doi: 10.1111/papt.12459. Epub 2023 Mar 9.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karen H Kallesøe principal investigator
Aarhus University Hospital, Department of Child and Adolescent Psychiatry and Aarhus University, Department of Clinical Medicine
Questions about this trial
What is this clinical trial studying?
A study testing App-based Compassion Program in people with Physiological Conditions and Distress, Emotional, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen H Kallesøe, MD, PhD, Associate Professor (+4561619418, karekall@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Twente Engagement with Ehealth Technologies Scale (TWEETS) (time frame: Measured at end of treatment (approximately Week 4)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07840404, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.