Terminal IllnessNCT05365919
Family Talk Intervention in the Context of Specialised Palliative Home Care
A study testing Family Talk Intervention in people with Terminal Illness, run by Ersta Sköndal University College at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Terminal Illness
- What is being tested?
- Family Talk Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2022to 31 Dec 2024
- 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 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
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 is Severely Ill: An Effectiveness-implementation Study
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.
Read the 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.
- Conditions
- Terminal Illness
- Being tested
- Family Talk Intervention
- Keywords
- Specialised palliative care, Communication, Family Intervention
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Talk InterventionOther
Also called Beardslee's 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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group will be offered to participate in the Family Talk Intervention Receives: Other: Family Talk Intervention |
| Standard support | No intervention | The control group will receive standard support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in family Communication over time. Family Adaptability and Cohesion Scale IV
Measures in self-rated family communication which is the primary outcome of the intervention
Measured: Six months
Secondary outcomes (7)
Changes in self-rated resilience. Resilience Scale (RS-14) ((Resilience Scale for Children (RS-10)).
Measures self-rated resilience in adults and children
Measured: Six months
Changes in self-rated grief. Prolonged Grief Disorder (PG-12/PG-13).
An instrument to screen for pathologic forms of grief before and after an expected death
Measured: Six months
Changes in self-rated anxiety. Generalized Anxiety Disorder (GAD)
Measures symptoms of anxiety
Measured: Six months
Changes in The Strengths and Difficulties Questionnaire (SDQ)
Measures self-rated strengths and difficulties. Has a proxy version for children
Measured: Six months
Changes in self-perceived parenting skill. Parental Skills Checklist (PSC)
Measures self-rated parenting abilities
Measured: Six months
Changes in factors needed for successful implementation.The Swedish Normalization Process Theory Measure (S-NoMAD)
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.
Measured: Six months
Changes in perception of organizational context. Alberta Context Tool (ACT)
For the implementation research. Measures organizational context for use in complex healthcare settings.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start1 Apr 2022
- Primary completion30 Jun 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Terminal IllnessStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A cluster-randomized trial will be conducted at 12 homecare services (6 services=intervention, 6 services=control).
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ersta Sköndal University College
- Sponsor type
- University, hospital or other
- Collaborators
- Forte
- Responsible party
- Principal investigator, Malin Lövgren, Ersta Sköndal University College
- Investigators
- Malin Lövgren, PhD, Principal investigator, Marie Cederschiölds University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365919
- Sponsor's protocol ID
- Marie Cederschiöld University
- Status last verified
- Sep 2025
- First submitted
- 4 Mar 2022
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thermaenius 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 is Severely Ill: An Effectiveness-implementation Study
- ClinicalTrials.gov ID
- NCT05365919
- Acronym / sponsor ID
- Marie Cederschiöld University
- Conditions
- Terminal Illness
- Keywords
- Specialised palliative care, Communication, Family Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Ersta Sköndal University CollegeUniversity, hospital or other
- Collaborators
- Forte
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 9 May 2022 (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.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A cluster-randomized trial will be conducted at 12 homecare services (6 services=intervention, 6 services=control).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Family Talk InterventionThe intervention group will be offered to participate in the Family Talk Intervention |
| Standard support | No intervention | –The control group will receive standard support |
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 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
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 InterventionAlso: Beardslee's 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). | Other | Intervention |
Primary outcome
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
7 secondary outcomes
Changes in self-rated resilience. Resilience Scale (RS-14) ((Resilience Scale for Children (RS-10)).
Time frame: Six months
Changes in self-rated grief. Prolonged Grief Disorder (PG-12/PG-13).
Time frame: Six months
Changes in self-rated anxiety. Generalized Anxiety Disorder (GAD)
Time frame: Six months
Changes in The Strengths and Difficulties Questionnaire (SDQ)
Time frame: Six months
Changes in self-perceived parenting skill. Parental Skills Checklist (PSC)
Time frame: Six months
Changes in factors needed for successful implementation.The Swedish Normalization Process Theory Measure (S-NoMAD)
Time frame: Six months
Changes in perception of organizational context. Alberta Context Tool (ACT)
Time frame: Six months
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 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
Marie Cederschiölds 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 Terminal Illness, 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?
Changes in family Communication over time. Family Adaptability and Cohesion Scale IV (time frame: Six months). 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 NCT05365919, which also lists 1 linked publication.
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.