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NCT Number: NCT07840404

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

  • No specific exclusion criteria

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

Secondary outcomes

  1. 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.

    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.

  2. Compassionate Parent

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

    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.

  3. 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.

    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.

  4. Other As Shamer Scale-2 (OAS-2)

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

    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.

  5. Difficulties in Emotion Regulation Scale (DERS-16)

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

    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.

  6. Patient Health Questionnaire (PHQ-9)

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

    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.

  7. Generalized Anxiety Disorder Scale (GAD-7)

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

    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.

  8. Oslo Social Support Scale (OSSS-3)

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

    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.

  9. EuroQol Five Dimensions (ED-Q5)

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

    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).

  10. Strengths and Difficulties Questionnaire (SDQ)

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

    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.

  11. Adverse Events Mini-Screen

    Time frame: Measured at end of intervention (approximately Week 4)

    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.

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Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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