About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Completed all four modules of the Hand in Hand intervention
Disqualifiers
No specific exclusion criteria
Trial design
Single group
Treatments tested in this trial
App-based Compassion Program
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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
Secondary outcomes
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.
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.
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.
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.
Locations
Sponsors and contacts
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University of Aarhus
Lead sponsor
Aarhus University Hospital
Collaborator
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