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

NCT05020158 | Recruiting

• 1 other identifier: Marie Cederschiöld
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Illness Terminal

Keywords

Pediatric palliative care; Adult palliative care; Family Intervention

Outcome Measures

Primary Outcomes (1)

• Changed family communication from Family Adaptability and Cohesion Scale IV (FACES IV)

  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).

Secondary Outcomes (8)

• Changed resilience for adults measured by the Resilience Scale (RS-14)

  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),

  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)

  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)

  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)

  At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).

Study Arms (1)

Family Talk intervention

EXPERIMENTAL

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: Family Talk Intervention

Interventions

Family Talk Intervention OTHER

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

Family Talk 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 that include a child with a life-threatening/life-limiting illness.
• months should have passed since diagnosis or relapse.
• \<2 members of the family need to participate

Sponsors & Collaborators

• Ersta Sköndal University College: lead

Study Sites (1)

Marie Cederschiöld University College

Stockholm, SE- 10061, 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

Study Officials

• Malin Lövgren, PhD

  Ersta Sköndal Bräcke University College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malin Lövgren, PhD

CONTACT

+46-76-6365090; malin.lovgren@mcsh.se

Maja Holm, PhD

CONTACT

+46700021529; maja.holm@shh.se

Study Design

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

Model Details: Pre-post effectiveness-implementation hybrid design

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: August 25, 2021
• Study Start: February 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)