Marie Cederschiöld University College
Stockholm, SE- 10061, Sweden
Location status: Recruiting
Recruiting
NCT Number: NCT05020158
The Family Talk Intervention When a Parent With Dependent Children or a Child is Severely Ill
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
6 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
-
Treatment and study plan
Family Talk Intervention
OtherA psychosocial family-based intervention that is designed to give support to an entire family when a child has life-threatening illness.
Primary outcomes
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Changed family communication from Family Adaptability and Cohesion Scale IV (FACES IV)
Time frame: At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
Measures family communication
Secondary outcomes
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Changed resilience for adults measured by the Resilience Scale (RS-14)
Time frame: At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
Measures psychosocial health for parents/guardians and for children aged 13 years and older
-
Changed resilience in children measured by the Resilience Scale for Children (RS-10),
Time frame: At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
Measures psychosocial health for children aged 8-12 years
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Changed symptoms of pathologic grief measured by Prolonged Grief Disorder (PG-12)
Time frame: At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
Measures pre-death grief
-
Generalized Anxiety Disorder (GAD)
Time frame: At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
Measures anxiety in adults
-
Changed feelings of strength and weaknesses in children measured by The Strengths and Difficulties Questionnaire (SDQ)
Time frame: At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
Measures self-perceived strength and weakness. Parent Proxy for children under 11 years.
-
Changed feelings of parental skill measured by the Parental Skill Questionnaire (SDQ)
Time frame: At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
Measures self-perceived parental skill
-
Changed key mechanisms to promote and inhibit implementation measured by The Swedish Normalization Process Theory Measure (S-NoMAD)
Time frame: At baseline (after FTI education), four months later (follow-up 1) and 12 months later (follow-up 2).
Characterizes and explains key mechanisms that promote and inhibit the implementation, embedding and integration of new health techniques, technologies and other complex interventions.
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Changed organizational context measured by Alberta Context Tool (ACT)
Time frame: At baseline (after FTI education), four months later (follow-up 1) and 12 months later (follow-up 2).
Measures organizational context for use in complex healthcare settings.
Study contacts
Contact information is provided by the study sponsor or research team.
Maja Holm, PhD
CONTACT
Malin Lövgren, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Ersta Sköndal University College
Other
Registry information
Official study title
The Family Talk Intervention in Clinical Practice When a Parent With Dependent Children or a Child is Severely Ill: An Effectiveness-implementation Study
Important dates
- Study start
- 2021
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- Aug 25, 2021
- Registry last updated
- Aug 28, 2024
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.