Family Talk Intervention in the Context of Specialised Palliative Home Care

Sponsor
Ersta Sköndal University College (Other)
Overall Status
Recruiting
CT.gov ID
NCT05365919
Collaborator
Forte (Industry)
400
1
2
33
12.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Family Talk Intervention
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A cluster-randomized trial will be conducted at 12 homecare services (6 services=intervention, 6 services=control).A cluster-randomized trial will be conducted at 12 homecare services (6 services=intervention, 6 services=control).
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Family Talk Intervention in Clinical Practice When a Parent With Dependent Children is Severely Ill: An Effectiveness-implementation Study
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

The intervention group will be offered to participate in the Family Talk 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).
Other Names:
  • Beardslee's intervention
  • No Intervention: Standard support

    The control group will receive standard support

    Outcome Measures

    Primary Outcome Measures

    1. Changes in family Communication over time. Family Adaptability and Cohesion Scale IV [Six months]

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

    Secondary Outcome Measures

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

      Measures self-rated resilience in adults and children

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

      Measures symptoms of anxiety

    4. Changes in The Strengths and Difficulties Questionnaire (SDQ) [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) [Six months]

      Measures self-rated parenting abilities

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Marie Cederschiöld Unicersity College Stockholm Sweden

    Sponsors and Collaborators

    • Ersta Sköndal University College
    • Forte

    Investigators

    • Principal Investigator: Malin Lövgren, PhD, Marie Cederschiölds University College

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Malin Lövgren, Associate professor, Ersta Sköndal University College
    ClinicalTrials.gov Identifier:
    NCT05365919
    Other Study ID Numbers:
    • Marie Cederschiöld University
    First Posted:
    May 9, 2022
    Last Update Posted:
    May 9, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Malin Lövgren, Associate professor, Ersta Sköndal University College

    Study Results

    No Results Posted as of May 9, 2022