Clinical trial NCT03119545: A Family-Centered Intervention When a Parent is Cared for in Specialized Homecare
Official title: A Family-Centered Intervention When a Parent is Cared for in Specialized Homecare
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palliative Care
Keywords: intervention
support program
family centered
parental death
Lead sponsor: Ersta Sköndal University College
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 33
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* At least one Child in the family 6-19 years
* Speaking and understanding Swedish
* One parent with severe illness or dying

Exclusion Criteria:

* If the family is in need of interpreter

Primary outcomes:
measure: Self-reported family communication, change over time
timeFrame: Baseline (start of intervention), follow up 1 (after two months), follow up 2 (after one year).
measure: Self-reported family communication
timeFrame: After five weeks from the start of the intervention
Secondary outcomes:
measure: Self -reported knowledge about the illness, change over time
timeFrame: Baseline (start of intervention), follow up 1 (after two months), follow up 2 (after one year).
measure: Self -reported knowledge about the illness
timeFrame: After five weeks from the start of the intervention
measure: Self-reported psychological distress, change over time
timeFrame: Baseline (start of intervention), follow up 1 (after two months), follow up 2 (after one year).
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Ersta Sköndal Bräcke University College
Study officials:
affiliation: Ersta Sköndal Bräcke University College
name: Malin Lövgren, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Eklund 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.
citation: Eklund 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.