NCT03119545

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 3, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2019

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

1.5 years

First QC Date

April 3, 2017

Last Update Submit

June 24, 2019

Conditions

Keywords

interventionsupport programfamily centeredparental death

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Self -reported knowledge about the illness, change over time

    Baseline (start of intervention), follow up 1 (after two months), follow up 2 (after one year).

  • Self -reported knowledge about the illness

    After five weeks from the start of the intervention

  • Self-reported psychological distress, change over time

    Baseline (start of intervention), follow up 1 (after two months), follow up 2 (after one year).

Study Arms (2)

Beardslee family centered intervention

EXPERIMENTAL

This Group will have the family centered program.

Behavioral: Beardslee family centered intervention

Comparison group

NO INTERVENTION

This Group will have standard care

Interventions

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.

Also known as: the family talk intervention
Beardslee family centered intervention

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • If the family is in need of interpreter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ersta Sköndal Bräcke University College

Stockholm, SE- 10061, Sweden

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Parental Death

Condition Hierarchy (Ancestors)

DeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Malin Lövgren, PhD

    Ersta Sköndal Bräcke University College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 3, 2017

First Posted

April 18, 2017

Study Start

March 1, 2017

Primary Completion

September 1, 2018

Study Completion

June 24, 2019

Last Updated

June 25, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations