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Clinical Trials/NCT05365919
NCT05365919
Recruiting
N/A

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

Ersta Sköndal University College1 site in 1 country400 target enrollmentApril 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Terminal Illness
Sponsor
Ersta Sköndal University College
Enrollment
400
Locations
1
Primary Endpoint
Changes in family Communication over time. Family Adaptability and Cohesion Scale IV
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ersta Sköndal University College
Responsible Party
Principal Investigator
Principal Investigator

Malin Lövgren

Associate professor

Ersta Sköndal University College

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

  • Not provided

Outcomes

Primary Outcomes

Changes in family Communication over time. Family Adaptability and Cohesion Scale IV

Time Frame: Six months

Measures in self-rated family communication which is the primary outcome of the intervention

Secondary Outcomes

  • Changes in factors needed for successful implementation.The Swedish Normalization Process Theory Measure (S-NoMAD)(Six months)
  • Changes in self-rated resilience. Resilience Scale (RS-14) ((Resilience Scale for Children (RS-10)).(Six months)
  • Changes in self-rated anxiety. Generalized Anxiety Disorder (GAD)(Six months)
  • Changes in perception of organizational context. Alberta Context Tool (ACT)(Six months)
  • Changes in self-rated grief. Prolonged Grief Disorder (PG-12/PG-13).(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 Sites (1)

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