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

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ClinicalTrials.gov Identifier: NCT03119545
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Malin Lövgren, Ersta Sköndal University College

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.

Condition or disease Intervention/treatment Phase
Palliative Care Behavioral: Beardslee family centered intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Family-Centered Intervention When a Parent is Cared for in Specialized Homecare
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : June 24, 2019

Arm Intervention/treatment
Experimental: Beardslee family centered intervention
This Group will have the family centered program.
Behavioral: Beardslee family centered 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.
Other Name: the family talk intervention

No Intervention: Comparison group
This Group will have standard care



Primary Outcome Measures :
  1. 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).

  2. Self-reported family communication [ Time Frame: After five weeks from the start of the intervention ]
    Will be measured by interviews


Secondary Outcome Measures :
  1. 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). ]
    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).

  2. Self -reported knowledge about the illness [ Time Frame: After five weeks from the start of the intervention ]
    will be measured by interviews

  3. 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). ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119545


Locations
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Sweden
Ersta Sköndal Bräcke University College
Stockholm, Sweden, SE- 10061
Sponsors and Collaborators
Ersta Sköndal University College
Investigators
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Principal Investigator: Malin Lövgren, PhD Ersta Sköndal Bräcke University College
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Malin Lövgren, Associate professor, Ersta Sköndal University College
ClinicalTrials.gov Identifier: NCT03119545    
Other Study ID Numbers: 2017/7-31/1
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Malin Lövgren, Ersta Sköndal University College:
intervention
support program
family centered
parental death