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

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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).

Eligibility Criteria

• 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

Contacts and Locations

Locations

Sweden

Ersta Sköndal Bräcke University College

Stockholm, Sweden, SE- 10061

Sponsors and Collaborators

Ersta Sköndal University College

Investigators

• Principal Investigator: Malin Lövgren, PhD; Ersta Sköndal Bräcke University College

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Eklund R, Alvariza A, Kreicbergs U, Jalmsell L, Lövgren 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.

Eklund R, Kreicbergs U, Alvariza A, Lövgren 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.

• 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
• Last Update Posted: June 25, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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