Hand in Hand: Feasibility of a Compassion-Focused App to Support Parents of Children With Mental Health Problems

NCT07840404 | Not Yet Recruiting

• 1 other identifier: 1-10-72-28-26
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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. 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; Compassion

Keywords

Caregiving Stress; Distress, Emotional; Parental burnout; Compassion focused therapy

Outcome Measures

Primary Outcomes (4)

• 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)

• 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.

• 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 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 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)

  Measured at baseline, mid-treatment (approximately Day 14), end of treatment (approximately Week 4), and at 3 months follow up.

• Compassionate Parent

  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)

  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)

  Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.

• Difficulties in Emotion Regulation Scale (DERS-16)

  Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.

Study Arms (1)

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.

Behavioral: App-based Compassion Program

Interventions

App-based Compassion Program BEHAVIORAL

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.

Participant Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Related Publications (1)

• 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.

  PMID: 36892093 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Caregiver Burden; Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Karen H Kallesøe

  Aarhus University Hospital, Department of Child and Adolescent Psychiatry and Aarhus University, Department of Clinical Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen H Kallesøe, MD, PhD, Associate Professor

CONTACT

+4561619418; karekall@rm.dk

Emma N Tonsberg, MSc

CONTACT

+4551349057; EMTONS@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 25, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share