Family Talk Intervention in the Context of Specialised Palliative Home Care

Terminal Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05365919
• Other study ID #: Marie Cederschiöld University
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Ersta Sköndal University College
• Contact: Malin Lövgren, PhD
• Phone: +46766365090
• Email: malin.lovgren[@]mchs.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• Terminal Illness

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).

Locations

Country	Name	City	State
Sweden	Marie Cederschiöld Unicersity College	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Ersta Sköndal University College	Forte

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Changes in self-rated anxiety. Generalized Anxiety Disorder (GAD)	Measures symptoms of anxiety	Six months
Secondary	Changes in The Strengths and Difficulties Questionnaire (SDQ)	Measures self-rated strengths and difficulties. Has a proxy version for children	Six months
Secondary	Changes in self-perceived parenting skill. Parental Skills Checklist (PSC)	Measures self-rated parenting abilities	Six months
Secondary	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
Secondary	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