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Completed

NCT Number: NCT05365919

Family Talk Intervention in the Context of Specialised Palliative Home Care

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.

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Key information

Conditions

Terminal Illness Behavior Communication

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marie Cederschiöld Unicersity College

Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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).

Other names: Beardslee's intervention

Primary outcomes

  1. 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

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

    Time frame: Six months

    Measures self-rated resilience in adults and children

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

    Time frame: Six months

    An instrument to screen for pathologic forms of grief before and after an expected death

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

    Time frame: Six months

    Measures symptoms of anxiety

  4. Changes in The Strengths and Difficulties Questionnaire (SDQ)

    Time frame: Six months

    Measures self-rated strengths and difficulties. Has a proxy version for children

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

    Time frame: Six months

    Measures self-rated parenting abilities

  6. Changes in factors needed for successful implementation.The Swedish Normalization Process Theory Measure (S-NoMAD)

    Time frame: Six months

    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.

  7. Changes in perception of organizational context. Alberta Context Tool (ACT)

    Time frame: Six months

    For the implementation research. Measures organizational context for use in complex healthcare settings.

Sponsors and collaborators

Lead sponsor

Ersta Sköndal University College

Other

Collaborators

  • Forte

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 9, 2022
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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