- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07840404
Hand in Hand: Feasibility of a Compassion-Focused App to Support Parents of Children With Mental Health Problems
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Karen H Kallesøe, MD, PhD, Associate Professor
- Numer telefonu: +4561619418
- E-mail: karekall@rm.dk
Kopia zapasowa kontaktu do badania
- Nazwa: Emma N Tonsberg, MSc
- Numer telefonu: +4551349057
- E-mail: EMTONS@rm.dk
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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. |
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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Twente Engagement with Ehealth Technologies Scale (TWEETS)
Ramy czasowe: 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. |
Measured at end of treatment (approximately Week 4)
|
|
Parental Burnout Assessment Scale (PBA)
Ramy czasowe: 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. |
Measured at baseline, mid-treatment (approximately Day 14), end of treatment (approximately Week 4), and at 3 months follow up.
|
|
Three Circles Digital Scale
Ramy czasowe: 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. |
Measured at baseline, mid-treatment (approximately Day 14), end of treatment (approximately Week 4), and at 3 months follow up.
|
|
Family Empowerment Scale (FES)
Ramy czasowe: 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 |
Measured at baseline, mid-treatment (approximately Day 14), end of treatment (approximately Week 4), and at 3 months follow up.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
The Self-Compassion Scale Short Form (SCS-SF)
Ramy czasowe: 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. |
Measured at baseline, mid-treatment (approximately Day 14), end of treatment (approximately Week 4), and at 3 months follow up.
|
|
Compassionate Parent
Ramy czasowe: 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. |
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)
Ramy czasowe: 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. |
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)
Ramy czasowe: 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. |
Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.
|
|
Difficulties in Emotion Regulation Scale (DERS-16)
Ramy czasowe: 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. |
Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.
|
|
Patient Health Questionnaire (PHQ-9)
Ramy czasowe: 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. |
Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.
|
|
Generalized Anxiety Disorder Scale (GAD-7)
Ramy czasowe: 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. |
Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.
|
|
Oslo Social Support Scale (OSSS-3)
Ramy czasowe: 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. |
Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.
|
|
EuroQol Five Dimensions (ED-Q5)
Ramy czasowe: 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). |
Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.
|
|
Strengths and Difficulties Questionnaire (SDQ)
Ramy czasowe: 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. |
Measured at baseline, end of treatment (approximately Week 4), and at 3 months follow up.
|
|
Adverse Events Mini-Screen
Ramy czasowe: 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. |
Measured at end of intervention (approximately Week 4)
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Karen H Kallesøe, Aarhus University Hospital, Department of Child and Adolescent Psychiatry and Aarhus University, Department of Clinical Medicine
Publikacje i pomocne linki
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 1-10-72-28-26
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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