The Family Talk Intervention When a Parent With Dependent Children or a Child is Severely Ill

NCT ID: NCT05020158

Last Updated: 2024-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Illness Terminal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pre-post effectiveness-implementation hybrid design
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Family Talk Intervention

Intervention Type OTHER

A psychosocial family-based intervention that is designed to give support to an entire family when a child has life-threatening illness.

Interventions

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Family Talk Intervention

A psychosocial family-based intervention that is designed to give support to an entire family when a child has life-threatening illness.

Intervention Type OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ersta Sköndal University College

OTHER

Sponsor Role lead

Responsible Party

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Malin Lövgren

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Malin Lövgren, PhD

Role: PRINCIPAL_INVESTIGATOR

Ersta Sköndal Bräcke University College

Locations

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Marie Cederschiöld University College

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Malin Lövgren, PhD

Role: CONTACT

+46-76-6365090

Maja Holm, PhD

Role: CONTACT

+46700021529

Facility Contacts

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Malin Lövgren, PhD

Role: primary

0046733302789

References

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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.

Reference Type DERIVED
PMID: 40584244 (View on PubMed)

Other Identifiers

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Marie Cederschiöld

Identifier Type: -

Identifier Source: org_study_id

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