Clinical trial NCT05020158: The Family Talk Intervention When a Parent With Dependent Children or a Child is Severely Ill
Official title: The Family Talk Intervention in Clinical Practice When a Parent With Dependent Children or a Child is Severely Ill: An Effectiveness-implementation Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Illness Terminal
Keywords: Pediatric palliative care
Adult palliative care
Family Intervention
Lead sponsor: Ersta Sköndal University College
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-post effectiveness-implementation hybrid design
Primary purpose: SUPPORTIVE_CARE

Brief summary: The overall aim of this study is to evaluate the effects and the implementation process of the Family Talk Intervention (FTI) in clinical practice when a child or a parent of dependent children has a life-threatening/life-limiting illness (cancer, neurological diseases, etc.). During 2021, FTI will be implemented in several different care contexts including a children's hospital and a university hospital in Sweden. Social workers will be educated in using the FTI in their clinical work. This study has a pre-post effectiveness-implementation hybrid design using mixed method. Data collection will be made using web-based questionnaires and interviews with families and social workers, and observations will be performed throughout the study.

Detailed description: The Family Talk Intervention (FTI), also called Beardslee's Family Intervention is a manual-based complex intervention and involves families who have children aged 6-18 years. The core elements are to support the families in talking about illness-related subjects, support the parents in understanding the needs of their children and how to support them, and support the families in identifying their strengths and how best to use them.

The overall aim of this trial is to evaluate the effects and the implementation process of FTI in clinical practice when a parent or a child has a life-threatening/life-limiting illness (cancer, neurological diseases, etc.). More specifically, to examine the effects of FTI regarding family communication and psychosocial health among family members (Aim 1) and describe facilitating factors and barriers for implementing FTI in everyday clinical practice (Aim 2).

The FTI has previously been pilot-tested in the context of specialized palliative home care with promising results. In pilot-tests, an assigned interventionist was used for intervention delivery, while in this continued trial, social workers will deliver the intervention as a part of their clinical work.

This trial has a pre-post effectiveness-implementation hybrid design using mixed method. It will be placed at a children's hospital and at a university hospital in Sweden and conducted by all social workers working there (n=25). Education of social workers in working with FTI will take place during 2021 and families will be invited to the project from April 2022 and until power has been reached. Data will be collected using web-based questionnaires and interviews with families and social workers, and observations will be performed throughout the study.

Eligibility criteria: Inclusion Criteria:

* Families that include a child with a life-threatening/life-limiting illness.
* 2-3 months should have passed since diagnosis or relapse.
* \<2 members of the family need to participate

Exclusion Criteria:

-

Primary outcomes:
measure: Changed family communication from Family Adaptability and Cohesion Scale IV (FACES IV)
timeFrame: At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
Secondary outcomes:
measure: Changed resilience for adults measured by the Resilience Scale (RS-14)
timeFrame: At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
measure: Changed resilience in children measured by the Resilience Scale for Children (RS-10),
timeFrame: At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
measure: Changed symptoms of pathologic grief measured by Prolonged Grief Disorder (PG-12)
timeFrame: At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
measure: Generalized Anxiety Disorder (GAD)
timeFrame: At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
measure: Changed feelings of strength and weaknesses in children measured by The Strengths and Difficulties Questionnaire (SDQ)
timeFrame: At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
measure: Changed feelings of parental skill measured by the Parental Skill Questionnaire (SDQ)
timeFrame: At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
measure: Changed key mechanisms to promote and inhibit implementation measured by The Swedish Normalization Process Theory Measure (S-NoMAD)
timeFrame: At baseline (after FTI education), four months later (follow-up 1) and 12 months later (follow-up 2).
measure: Changed organizational context measured by Alberta Context Tool (ACT)
timeFrame: At baseline (after FTI education), four months later (follow-up 1) and 12 months later (follow-up 2).
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Marie Cederschiöld University College
Study officials:
affiliation: Ersta Sköndal Bräcke University College
name: Malin Lövgren, PhD
role: PRINCIPAL_INVESTIGATOR
References: