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Familjesamtalintervention när en förälder med beroende barn eller ett barn är svårt sjuk

18 september 2026 uppdaterad av: Malin Lövgren, Ersta Sköndal University College

The Family Talk Intervention in Clinical Practice När en förälder med beroende barn eller ett barn är allvarligt sjuk: en studie av effektivitetsimplementering

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

150

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Stockholm, Sverige, SE- 10061
        • Marie Cederschiöld University College

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

6 år och äldre (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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:

-

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Changed family communication from Family Adaptability and Cohesion Scale IV (FACES IV)
Tidsram: 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).

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Changed resilience for adults measured by the Resilience Scale (RS-14)
Tidsram: 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),
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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).

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Malin Lövgren, PhD, Ersta Sköndal Bräcke University College

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 februari 2021

Primärt slutförande (Faktisk)

30 augusti 2025

Avslutad studie (Faktisk)

31 augusti 2025

Studieregistreringsdatum

Först inskickad

11 maj 2021

Först inskickad som uppfyllde QC-kriterierna

18 augusti 2021

Första postat (Faktisk)

25 augusti 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 september 2026

Senast verifierad

1 september 2025

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • Marie Cederschiöld

Plan för individuella deltagardata (IPD)

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NEJ

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