The Family Talk Intervence, když je rodič se závislými dětmi nebo dítě vážně nemocný
Intervence Family Talk v klinické praxi, když je rodič se závislými dětmi nebo dítě těžce nemocný: Studie efektivnosti implementace
The overall aim of this study is to evaluate the effects and the implementation process of the Family Talk Intervention (FTI) in clinical practice when a child or a parent of dependent children has a life-threatening/life-limiting illness (cancer, neurological diseases, etc.). During 2021, FTI will be implemented in several different care contexts including a children's hospital and a university hospital in Sweden. Social workers will be educated in using the FTI in their clinical work. This study has a pre-post effectiveness-implementation hybrid design using mixed method. Data collection will be made using web-based questionnaires and interviews with families and social workers, and observations will be performed throughout the study.
Přehled studie
Detailní popis
The Family Talk Intervention (FTI), also called Beardslee's Family Intervention is a manual-based complex intervention and involves families who have children aged 6-18 years. The core elements are to support the families in talking about illness-related subjects, support the parents in understanding the needs of their children and how to support them, and support the families in identifying their strengths and how best to use them.
The overall aim of this trial is to evaluate the effects and the implementation process of FTI in clinical practice when a parent or a child has a life-threatening/life-limiting illness (cancer, neurological diseases, etc.). More specifically, to examine the effects of FTI regarding family communication and psychosocial health among family members (Aim 1) and describe facilitating factors and barriers for implementing FTI in everyday clinical practice (Aim 2).
The FTI has previously been pilot-tested in the context of specialized palliative home care with promising results. In pilot-tests, an assigned interventionist was used for intervention delivery, while in this continued trial, social workers will deliver the intervention as a part of their clinical work.
This trial has a pre-post effectiveness-implementation hybrid design using mixed method. It will be placed at a children's hospital and at a university hospital in Sweden and conducted by all social workers working there (n=25). Education of social workers in working with FTI will take place during 2021 and families will be invited to the project from April 2022 and until power has been reached. Data will be collected using web-based questionnaires and interviews with families and social workers, and observations will be performed throughout the study.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
-
Stockholm, Švédsko, SE- 10061
- Marie Cederschiöld University College
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Families that include a child with a life-threatening/life-limiting illness.
- 2-3 months should have passed since diagnosis or relapse.
- <2 members of the family need to participate
Exclusion Criteria:
-
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Family Talk intervention
FTI entails six meetings, with intervals of 1-2 weeks between meetings. Meetings 1-2 include only the parent(s) and focus on their experiences of the situation, as well as the consequences of the diagnosis for each family member. The parent(s) will formulate the goal of the intervention. Meeting 3: Interviews will be held with each child and includes the child's life situation. Meeting 4 includes the parent(s) and focuses on planning the family meeting. The children's thoughts and questions serve as a guide for the upcoming family meeting. Meeting 5 is a family meeting and consists of questions and issues raised earlier by the family members. Meeting 6 is a follow-up with all family members. The meeting is guided by the family members' needs, e.g., regarding communication and parenting. If the intervention is interrupted unexpectedly and cannot be finished as scheduled due to extraordinary circumstances, extra meetings are available (Meetings 7-11). |
A psychosocial family-based intervention that is designed to give support to an entire family when a child has life-threatening illness. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Changed family communication from Family Adaptability and Cohesion Scale IV (FACES IV)
Časové okno: At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
|
Measures family communication |
At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Changed resilience for adults measured by the Resilience Scale (RS-14)
Časové okno: At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
|
Measures psychosocial health for parents/guardians and for children aged 13 years and older |
At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
|
|
Changed resilience in children measured by the Resilience Scale for Children (RS-10),
Časové okno: At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
|
Measures psychosocial health for children aged 8-12 years |
At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
|
|
Changed symptoms of pathologic grief measured by Prolonged Grief Disorder (PG-12)
Časové okno: At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
|
Measures pre-death grief |
At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
|
|
Generalized Anxiety Disorder (GAD)
Časové okno: At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
|
Measures anxiety in adults |
At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
|
|
Changed feelings of strength and weaknesses in children measured by The Strengths and Difficulties Questionnaire (SDQ)
Časové okno: At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
|
Measures self-perceived strength and weakness. Parent Proxy for children under 11 years. |
At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
|
|
Changed feelings of parental skill measured by the Parental Skill Questionnaire (SDQ)
Časové okno: At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
|
Measures self-perceived parental skill |
At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
|
|
Changed key mechanisms to promote and inhibit implementation measured by The Swedish Normalization Process Theory Measure (S-NoMAD)
Časové okno: At baseline (after FTI education), four months later (follow-up 1) and 12 months later (follow-up 2).
|
Characterizes and explains key mechanisms that promote and inhibit the implementation, embedding and integration of new health techniques, technologies and other complex interventions. |
At baseline (after FTI education), four months later (follow-up 1) and 12 months later (follow-up 2).
|
|
Changed organizational context measured by Alberta Context Tool (ACT)
Časové okno: At baseline (after FTI education), four months later (follow-up 1) and 12 months later (follow-up 2).
|
Measures organizational context for use in complex healthcare settings. |
At baseline (after FTI education), four months later (follow-up 1) and 12 months later (follow-up 2).
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Malin Lövgren, PhD, Ersta Sköndal Bräcke University College
Publikace a užitečné odkazy
Obecné publikace
- Iveus K, Holm M, Arestedt K, Kreicbergs U, Anmyr L, Udo C, Lovgren M. The Family Talk Intervention Improves Family Communication and Psychosocial Health Among Families in Pediatric Palliative Care: A Pre-Post Evaluation Study. Children (Basel). 2026 Mar 28;13(4):471. doi: 10.3390/children13040471.
- Thermaenius I, Holm M, Arestedt K, Udo C, Alvariza A, Lundberg T, Wallin L, Lovgren M. Implementing the Family Talk Intervention among families with a severely ill parent or child with palliative care needs- a longitudinal study of the perspectives of hospital social workers. Front Health Serv. 2025 Jun 13;5:1527431. doi: 10.3389/frhs.2025.1527431. eCollection 2025.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- Marie Cederschiöld
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .