Family Talk Intervention in the Context of Specialised Palliative Home Care

The Family Talk Intervention in Clinical Practice When a Parent With Dependent Children is Severely Ill: An Effectiveness-implementation Study

This intervention study aims to evaluate a psychosocial family based intervention in clinical practice, the Family Talk Intervention (FTI), for families with dependent children affected by life-threatening/life-limiting illness, when a parent is ill.

The study has an effectiveness implementation hybrid design where both the effects of FTI and the implementation process in clinical practice are examined.

Study Overview

• Status: Recruiting
• Conditions: Terminal Illness
• Intervention / Treatment: Other: Family Talk Intervention

Detailed Description

When a family with dependent children is affected by severe illness this affects the entire family. Still, there is little research evaluating support to such families. This intervention study aims to evaluate a psychosocial family based intervention in clinical practice, the Family Talk Intervention (FTI), for families with dependent children affected by life-threatening/life-limiting illness, when a parent is ill.

The study has an effectiveness implementation hybrid design where both the effects of FTI and the implementation process in clinical practice are examined. FTI will be carried out as a cluster randomized trial at 12 clinics in specialized palliative homecare (6 units=intervention, 6 units=control).

All social workers at these clinics will receive education and training in FTI in 2021. From 2022, FTI will be offered to families cared for at these care contexts.

FTI is manual-based and consists of 6 meetings with the families (together and individually) and is led by the FTI-educated social workers. The aim of FTI are to support the family in talking about illness-related subjects (e.g. prognosis, stress), support parenting, and support the family in identifying their strengths and how to best use them.

FTI will be evaluated through surveys and interviews with families before FTI/baseline and after completed intervention (3 and 6 months after baseline). Further, social workers will be invited to compete questionnaires and take part in focus groups about their experiences of FTI.

The research group has conducted pilot-studies on FTI in these contexts with positive results. The present study allows us to take a further step in the evaluation of FTI- evaluate FTI under real conditions.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Malin Lövgren, PhD; Phone Number: +46766365090; Email: malin.lovgren@mchs.se
• Study Contact Backup: Name: Anette Alvariza, PhD; Phone Number: +46766365073; Email: anette.alvariza@mchs.se

Study Locations

• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Marie Cederschiöld Unicersity College
    • Contact: Malin Lövgren, PhD; Email: malin.lovgren@mcsh.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Families affected by a life-threatening or life-limiting illness and have dependent children, ill or health aged 0-19 years and
• Enrolled in specialized palliative home care
• At least two family members have accepted to participate

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The intervention group will be offered to participate in the Family Talk Intervention	Other: 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).; Other Names: Beardslee's intervention
No Intervention: Standard support; The control group will receive standard support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in family Communication over time. Family Adaptability and Cohesion Scale IV	Measures in self-rated family communication which is the primary outcome of the intervention	Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in self-rated resilience. Resilience Scale (RS-14) ((Resilience Scale for Children (RS-10)).	Measures self-rated resilience in adults and children	Six months
Changes in self-rated grief. Prolonged Grief Disorder (PG-12/PG-13).	An instrument to screen for pathologic forms of grief before and after an expected death	Six months
Changes in self-rated anxiety. Generalized Anxiety Disorder (GAD)	Measures symptoms of anxiety	Six months
Changes in The Strengths and Difficulties Questionnaire (SDQ)	Measures self-rated strengths and difficulties. Has a proxy version for children	Six months
Changes in self-perceived parenting skill. Parental Skills Checklist (PSC)	Measures self-rated parenting abilities	Six months
Changes in factors needed for successful implementation.The Swedish Normalization Process Theory Measure (S-NoMAD)	For the implementation research. Characterizes and explains key mechanisms that promote and inhibit the implementation, embedding and integration of new health techniques, technologies and other complex interventions.	Six months
Changes in perception of organizational context. Alberta Context Tool (ACT)	For the implementation research. Measures organizational context for use in complex healthcare settings.	Six months

Collaborators and Investigators

• Sponsor: Ersta Sköndal University College
• Collaborators: Forte
• Investigators: Principal Investigator: Malin Lövgren, PhD, Marie Cederschiölds University College

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 4, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 15, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Family Intervention; Communication; Specialised palliative care
• Other Study ID Numbers: Marie Cederschiöld University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No