Illness TerminalNCT05020158
The Family Talk Intervention When a Parent With Dependent Children or a Child is Severely Ill
A study testing Family Talk Intervention in people with Illness Terminal, run by Ersta Sköndal University College at 1 site in Sweden.
Trial 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.). Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Illness Terminal
- What is being tested?
- Family Talk Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2021to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Illness Terminal
- Being tested
- Family Talk Intervention
- Keywords
- Pediatric palliative care, Adult palliative care, Family Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Talk InterventionOther
A psychosocial family-based intervention that is designed to give support to an entire family when a child has life-threatening illness.
| Study group | Role | What they receive |
|---|---|---|
| Family Talk intervention | Experimental | 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). Receives: Other: Family Talk Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changed family communication from Family Adaptability and Cohesion Scale IV (FACES IV)
Measures family communication
Measured: 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 (8)
Changed resilience for adults measured by the Resilience Scale (RS-14)
Measures psychosocial health for parents/guardians and for children aged 13 years and older
Measured: At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
Changed resilience in children measured by the Resilience Scale for Children (RS-10),
Measures psychosocial health for children aged 8-12 years
Measured: At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
Changed symptoms of pathologic grief measured by Prolonged Grief Disorder (PG-12)
Measures pre-death grief
Measured: At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
Generalized Anxiety Disorder (GAD)
Measures anxiety in adults
Measured: At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
Changed feelings of strength and weaknesses in children measured by The Strengths and Difficulties Questionnaire (SDQ)
Measures self-perceived strength and weakness. Parent Proxy for children under 11 years.
Measured: At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
Changed feelings of parental skill measured by the Parental Skill Questionnaire (SDQ)
Measures self-perceived parental skill
Measured: At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
Changed key mechanisms to promote and inhibit implementation measured by The Swedish Normalization Process Theory Measure (S-NoMAD)
Characterizes and explains key mechanisms that promote and inhibit the implementation, embedding and integration of new health techniques, technologies and other complex interventions.
Measured: At baseline (after FTI education), four months later (follow-up 1) and 12 months later (follow-up 2).
Changed organizational context measured by Alberta Context Tool (ACT)
Measures organizational context for use in complex healthcare settings.
Measured: At baseline (after FTI education), four months later (follow-up 1) and 12 months later (follow-up 2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start1 Feb 2021
- Primary completion30 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Illness TerminalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post effectiveness-implementation hybrid design
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ersta Sköndal University College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malin Lövgren, Ersta Sköndal University College
- Investigators
- Malin Lövgren, PhD, Principal investigator, Ersta Sköndal Bräcke University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020158
- Sponsor's protocol ID
- Marie Cederschiöld
- Status last verified
- Sep 2025
- First submitted
- 11 May 2021
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Iveus K, Holm M, Arestedt K, Kreicbergs U, Anmyr L, Udo C, Lovgren M. The Family Talk Intervention Improves Family Communication and Psychosocial Health Among Families in Pediatric Palliative Care: A Pre-Post Evaluation Study. Children (Basel). 2026 Mar 28;13(4):471. doi: 10.3390/children13040471.
PubMed 42073048Thermaenius I, Holm M, Arestedt K, Udo C, Alvariza A, Lundberg T, Wallin L, Lovgren M. Implementing the Family Talk Intervention among families with a severely ill parent or child with palliative care needs- a longitudinal study of the perspectives of hospital social workers. Front Health Serv. 2025 Jun 13;5:1527431. doi: 10.3389/frhs.2025.1527431. eCollection 2025.
PubMed 40584244
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05020158
- Acronym / sponsor ID
- Marie Cederschiöld
- Conditions
- Illness Terminal
- Keywords
- Pediatric palliative care, Adult palliative care, Family Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ersta Sköndal University CollegeUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post effectiveness-implementation hybrid design
| Arm | Type | Receives |
|---|---|---|
| Family Talk intervention | Experimental | Other: Family Talk InterventionFTI 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). |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Talk InterventionA psychosocial family-based intervention that is designed to give support to an entire family when a child has life-threatening illness. | Other | Family Talk intervention |
Primary outcome
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
8 secondary outcomes
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).
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).
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).
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).
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).
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Derived from this study: PubMed 42073048Iveus K, Holm M, Arestedt K, Kreicbergs U, Anmyr L, Udo C, Lovgren M. The Family Talk Intervention Improves Family Communication and Psychosocial Health Among Families in Pediatric Palliative Care: A Pre-Post Evaluation Study. Children (Basel). 2026 Mar 28;13(4):471. doi: 10.3390/children13040471.
- Derived from this study: PubMed 40584244Thermaenius I, Holm M, Arestedt K, Udo C, Alvariza A, Lundberg T, Wallin L, Lovgren M. Implementing the Family Talk Intervention among families with a severely ill parent or child with palliative care needs- a longitudinal study of the perspectives of hospital social workers. Front Health Serv. 2025 Jun 13;5:1527431. doi: 10.3389/frhs.2025.1527431. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malin Lövgren, PhD principal investigator
Ersta Sköndal Bräcke University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Talk Intervention in people with Illness Terminal, run by Ersta Sköndal University College at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05020158, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.