Family Talk Intervention in the Context of Specialised Palliative Home Care

NCT05365919 | Unknown

• 1 other identifier: Marie Cederschiöld University
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Terminal Illness

Keywords

Specialised palliative care; Communication; Family Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Changes in self-rated resilience. Resilience Scale (RS-14) ((Resilience Scale for Children (RS-10)).

  Six months

• Changes in self-rated grief. Prolonged Grief Disorder (PG-12/PG-13).

  Six months

• Changes in self-rated anxiety. Generalized Anxiety Disorder (GAD)

  Six months

• Changes in The Strengths and Difficulties Questionnaire (SDQ)

  Six months

• Changes in self-perceived parenting skill. Parental Skills Checklist (PSC)

  Six months

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group will be offered to participate in the Family Talk Intervention

Other: Family Talk Intervention

Standard support

NO INTERVENTION

The control group will receive standard support

Interventions

Family Talk Intervention OTHER

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).

Also known as: Beardslee's intervention

Intervention

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Ersta Sköndal University College: lead
• Forte: collaborator

Study Sites (1)

Marie Cederschiöld Unicersity College

Stockholm, Sweden

RECRUITING

Related Publications (1)

• 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.

  PMID: 40584244 DERIVED

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Malin Lövgren, PhD

  Marie Cederschiölds University College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malin Lövgren, PhD

CONTACT

+46766365090; malin.lovgren@mchs.se

Anette Alvariza, PhD

CONTACT

+46766365073; anette.alvariza@mchs.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: A cluster-randomized trial will be conducted at 12 homecare services (6 services=intervention, 6 services=control).

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: May 9, 2022
• Study Start: April 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)