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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 主要终点
- Twente Engagement with Ehealth Technologies Scale (TWEETS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •No specific exclusion criteria
研究组 & 干预措施
Participant Group
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.
干预措施: App-based Compassion Program (Behavioral)
结局指标
主要结局
Twente Engagement with Ehealth Technologies Scale (TWEETS)
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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
次要结局
- 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.)
- Patient Health Questionnaire (PHQ-9)(Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.)
- Generalized Anxiety Disorder Scale (GAD-7)(Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.)
- Oslo Social Support Scale (OSSS-3)(Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.)
- EuroQol Five Dimensions (ED-Q5)(Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.)
- Strengths and Difficulties Questionnaire (SDQ)(Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.)
- Adverse Events Mini-Screen(Measured at end of intervention (approximately Week 4))