A Family-Centered Intervention When a Parent is Cared for in Specialized Homecare

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Family-Centered Intervention When a Parent is Cared for in Specialized Homecare

Conditions
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Palliative Care

Intervention / Treatment
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* Behavioral: Beardslee family centered intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beardslee family centered intervention<br>This Group will have the family centered program. | Behavioral: Beardslee family centered intervention<br>* 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.<br>* Other names: the family talk intervention;|
| No Intervention: Comparison group<br>This Group will have standard care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 | After five weeks from the start of the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 | 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). | Baseline (start of intervention), follow up 1 (after two months), follow up 2 (after one year). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intervention, support program, family centered, parental death