Clinical trial NCT05365919: Family Talk Intervention in the Context of Specialised Palliative Home Care
Official title: The Family Talk Intervention in Clinical Practice When a Parent With Dependent Children is Severely Ill: An Effectiveness-implementation Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Terminal Illness
Keywords: Specialised palliative care
Communication
Family Intervention
Lead sponsor: Ersta Sköndal University College
Sponsor class: OTHER
Collaborators: name: Forte
First posted: 2022-05-09
Enrollment: 400
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A cluster-randomized trial will be conducted at 12 homecare services (6 services=intervention, 6 services=control).
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Changes in family Communication over time. Family Adaptability and Cohesion Scale IV
timeFrame: Six months
Secondary outcomes:
measure: Changes in self-rated resilience. Resilience Scale (RS-14) ((Resilience Scale for Children (RS-10)).
timeFrame: Six months
measure: Changes in self-rated grief. Prolonged Grief Disorder (PG-12/PG-13).
timeFrame: Six months
measure: Changes in self-rated anxiety. Generalized Anxiety Disorder (GAD)
timeFrame: Six months
measure: Changes in The Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Six months
measure: Changes in self-perceived parenting skill. Parental Skills Checklist (PSC)
timeFrame: Six months
measure: Changes in factors needed for successful implementation.The Swedish Normalization Process Theory Measure (S-NoMAD)
timeFrame: Six months
measure: Changes in perception of organizational context. Alberta Context Tool (ACT)
timeFrame: Six months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Marie Cederschiöld Unicersity College
Study officials:
affiliation: Marie Cederschiölds University College
name: Malin Lövgren, PhD
role: PRINCIPAL_INVESTIGATOR
References: