Palliative CareNCT03119545
A Family-Centered Intervention When a Parent is Cared for in Specialized Homecare
A study testing Beardslee family centered intervention in people with Palliative Care, run by Ersta Sköndal University College at 1 site in Sweden.
Trial summary
The overall purpose of this project is to evaluate a family-centered intervention (the Family Talk Intervention, by W. Beardslee) in families where a parent of children aged 6-19 years is seriously ill and cared for in specialized homecare. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Palliative Care
- What is being tested?
- Beardslee family centered intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2017to 24 Jun 2019
- 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
- At least one Child in the family 6-19 years
- Speaking and understanding Swedish
- One parent with severe illness or dying
Who cannot join
- If the family is in need of interpreter
Trial locations and contacts
1 site in 1 country.
About this study
The overall purpose of this project is to evaluate a family-centered intervention (the Family Talk Intervention, by W. Beardslee) in families where a parent of children aged 6-19 years is seriously ill and cared for in specialized homecare. The aims of the intervention are to increase family communication, the families' awareness of the impending death and their knowledge about the cancer illness, and thereby reduce the family members' long-term psychological distress.
Read the detailed description
The death of a parent is one of the most traumatic events that can happen to a Child. In our previous research, we have found that a lack of medical knowledge, communication and awareness of impending death increased long-term psychological morbidity among bereaved family members. Unfortunately, very few clinical interventions in palliative care have been conducted in Sweden.There is therefore a need to develop and evaluate interventions that aim to decrease the risk for psychological morbidity in families affected loss.
The overall purpose of this project is to evaluate a family-centered intervention (the Family Talk Intervention, by W. Beardslee) in families where a parent of children aged 6-19 years is seriously ill and cared for in specialized homecare. The aims of the intervention are to increase family communication, the families' awareness of the impending death and their knowledge about the cancer illness, and thereby reduce the family members' long-term psychological distress.
This study is a family-based intervention study among families where a parent of young children is seriously ill. It involves an intervention group and a comparison group. The two groups will consist of families where the seriously ill parent has at least one child in the age range 6-19 years. Around thirty families will be recruited by two interventionists through two specialized homecare unit in Stockholm and this is expected to take about 18 months. Families in the comparison group (N=30) will be recruited by a research member at two other specialized homecare units in the Stockholm area.
The effect of the intervention will be measured by questionnaires to both parents and children. Questionnaire data collection will be conducted before the intervention is started (baseline, for both intervention and control group). After two months there will be a follow-up for both groups. The next follow-up for both groups will be performed one year after the baseline.
In order to examine the meaning of the intervention for all family members and the study-feasibility we are planning to conduct interviews after meeting 5. Interviews with the whole family respectively each family members will be conducted.
- Conditions
- Palliative Care
- Being tested
- Beardslee family centered intervention
- Keywords
- intervention, support program, family centered, parental death
- Medical subject headings
- Parental Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beardslee family centered interventionBehavioural
Also called the family talk intervention
The method entails six meetings. The time for the meeting is 1-2 hours and is usually held once per week. Meetings 1 and 2) include only the parents and focus firstly on the ill parent's history and secondly on the well parent/relative. Meeting 3) includes interviews with each child aged 6-19 years, without the parents being present, concerning the child´s understanding of the disease, potential worries and questions. During the interview the child can formulate his or her own questions for the family meeting. Meeting 4) includes the parents and focuses on the planning of the family meeting. The child's thoughts and questions serve as a guide for the upcoming family meeting. Meeting 5) is the family meeting. Meeting 6) is a follow-up with all of the family members.
| Study group | Role | What they receive |
|---|---|---|
| Beardslee family centered intervention | Experimental | This Group will have the family centered program. Receives: Behavioral: Beardslee family centered intervention |
| Comparison group | No intervention | This Group will have standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported family communication, change over time
Will be measured using study specific questionnaires (6-7 years 26 items; 8-12 years 28 items; 13-19 years 52 items; patient 45 items; parent/other significant adult 54 items).
Measured: Baseline (start of intervention), follow up 1 (after two months), follow up 2 (after one year).
Self-reported family communication
Will be measured by interviews
Measured: After five weeks from the start of the intervention
Secondary outcomes (3)
Self -reported knowledge about the illness, change over time
Will be measured using study specific questionnaires (6-7 years 26 items; 8-12 years 28 items; 13-19 years 52 items; patient 45 items; parent/other significant adult 54 items).
Measured: Baseline (start of intervention), follow up 1 (after two months), follow up 2 (after one year).
Self -reported knowledge about the illness
will be measured by interviews
Measured: After five weeks from the start of the intervention
Self-reported psychological distress, change over time
Will be measured using questionnaires "The pediatric quality of Life inventory" (PEDS QL) (6-7 years 15 items; 8-19 years 16 items). "Generalized Anxiety Disorder Assessment" (GAD-7) for the adults (8 items).
Measured: Baseline (start of intervention), follow up 1 (after two months), follow up 2 (after one year).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start1 Mar 2017
- Primary completion1 Sep 2018
- Study completion24 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 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
- NCT03119545
- Sponsor's protocol ID
- 2017/7-31/1
- Status last verified
- Jun 2019
- First submitted
- 3 Apr 2017
- Last updated
- 25 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weber Falk M, Eklund R, Kreicbergs U, Alvariza A, Lovgren M. Breaking the silence about illness and death: Potential effects of a pilot study of the family talk intervention when a parent with dependent children receives specialized palliative home care. Palliat Support Care. 2022 Aug;20(4):512-518. doi: 10.1017/S1478951521001322.
PubMed 35876452Eklund R, Alvariza A, Kreicbergs U, Jalmsell L, Lovgren M. The family talk intervention for families when a parent is cared for in palliative care - potential effects from minor children's perspectives. BMC Palliat Care. 2020 Apr 16;19(1):50. doi: 10.1186/s12904-020-00551-y.
PubMed 32299420Eklund R, Kreicbergs U, Alvariza A, Lovgren M. The family talk intervention in palliative care: a study protocol. BMC Palliat Care. 2018 Feb 23;17(1):35. doi: 10.1186/s12904-018-0290-8.
PubMed 29471826
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Family-Centered Intervention When a Parent is Cared for in Specialized Homecare
- ClinicalTrials.gov ID
- NCT03119545
- Acronym / sponsor ID
- 2017/7-31/1
- Conditions
- Palliative Care
- Keywords
- intervention, support program, family centered, parental death
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Ersta Sköndal University CollegeUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 24 Jun 2019 (actual)
- First posted
- 18 Apr 2017 (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 purpose of this project is to evaluate a family-centered intervention (the Family Talk Intervention, by W. Beardslee) in families where a parent of children aged 6-19 years is seriously ill and cared for in specialized homecare. The aims of the intervention are to increase family communication, the families' awareness of the impending death and their knowledge about the cancer illness, and thereby reduce the family members' long-term psychological distress.
Detailed description
The death of a parent is one of the most traumatic events that can happen to a Child. In our previous research, we have found that a lack of medical knowledge, communication and awareness of impending death increased long-term psychological morbidity among bereaved family members. Unfortunately, very few clinical interventions in palliative care have been conducted in Sweden.There is therefore a need to develop and evaluate interventions that aim to decrease the risk for psychological morbidity in families affected loss.
The overall purpose of this project is to evaluate a family-centered intervention (the Family Talk Intervention, by W. Beardslee) in families where a parent of children aged 6-19 years is seriously ill and cared for in specialized homecare. The aims of the intervention are to increase family communication, the families' awareness of the impending death and their knowledge about the cancer illness, and thereby reduce the family members' long-term psychological distress.
This study is a family-based intervention study among families where a parent of young children is seriously ill. It involves an intervention group and a comparison group. The two groups will consist of families where the seriously ill parent has at least one child in the age range 6-19 years. Around thirty families will be recruited by two interventionists through two specialized homecare unit in Stockholm and this is expected to take about 18 months. Families in the comparison group (N=30) will be recruited by a research member at two other specialized homecare units in the Stockholm area.
The effect of the intervention will be measured by questionnaires to both parents and children. Questionnaire data collection will be conducted before the intervention is started (baseline, for both intervention and control group). After two months there will be a follow-up for both groups. The next follow-up for both groups will be performed one year after the baseline.
In order to examine the meaning of the intervention for all family members and the study-feasibility we are planning to conduct interviews after meeting 5. Interviews with the whole family respectively each family members will be conducted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beardslee family centered intervention | Experimental | Behavioral: Beardslee family centered interventionThis Group will have the family centered program. |
| Comparison group | No intervention | –This Group will have standard care |
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)
- At least one Child in the family 6-19 years
- Speaking and understanding Swedish
- One parent with severe illness or dying
Key exclusion criteria (1 listed)
- If the family is in need of interpreter
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 |
|---|---|---|
| Beardslee family centered interventionAlso: the family talk interventionThe method entails six meetings. The time for the meeting is 1-2 hours and is usually held once per week. Meetings 1 and 2) include only the parents and focus firstly on the ill parent's history and secondly on the well parent/relative. Meeting 3) includes interviews with each child aged 6-19 years, without the parents being present, concerning the child´s understanding of the disease, potential worries and questions. During the interview the child can formulate his or her own questions for the family meeting. Meeting 4) includes the parents and focuses on the planning of the family meeting. The child's thoughts and questions serve as a guide for the upcoming family meeting. Meeting 5) is the family meeting. Meeting 6) is a follow-up with all of the family members. | Behavioural | Beardslee family centered intervention |
Primary outcome
Self-reported family communication, change over time
Time frame: Baseline (start of intervention), follow up 1 (after two months), follow up 2 (after one year).
Will be measured using study specific questionnaires (6-7 years 26 items; 8-12 years 28 items; 13-19 years 52 items; patient 45 items; parent/other significant adult 54 items).
Self-reported family communication
Time frame: After five weeks from the start of the intervention
Will be measured by interviews
3 secondary outcomes
Self -reported knowledge about the illness, change over time
Time frame: Baseline (start of intervention), follow up 1 (after two months), follow up 2 (after one year).
Self -reported knowledge about the illness
Time frame: After five weeks from the start of the intervention
Self-reported psychological distress, change over time
Time frame: Baseline (start of intervention), follow up 1 (after two months), follow up 2 (after one year).
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 25 Jun 2019.
- Derived from this study: PubMed 35876452Weber Falk M, Eklund R, Kreicbergs U, Alvariza A, Lovgren M. Breaking the silence about illness and death: Potential effects of a pilot study of the family talk intervention when a parent with dependent children receives specialized palliative home care. Palliat Support Care. 2022 Aug;20(4):512-518. doi: 10.1017/S1478951521001322.
- Derived from this study: PubMed 32299420Eklund R, Alvariza A, Kreicbergs U, Jalmsell L, Lovgren M. The family talk intervention for families when a parent is cared for in palliative care - potential effects from minor children's perspectives. BMC Palliat Care. 2020 Apr 16;19(1):50. doi: 10.1186/s12904-020-00551-y.
- Derived from this study: PubMed 29471826Eklund R, Kreicbergs U, Alvariza A, Lovgren M. The family talk intervention in palliative care: a study protocol. BMC Palliat Care. 2018 Feb 23;17(1):35. doi: 10.1186/s12904-018-0290-8.
- 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 Beardslee family centered intervention in people with Palliative Care, 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 25 Jun 2019. 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?
Self-reported family communication, change over time (time frame: Baseline (start of intervention), follow up 1 (after two months), follow up 2 (after one year).). The study lists 2 primary outcomes in all. 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 NCT03119545, which also lists 3 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 25 Jun 2019.