Ignite Creation Date:
2024-05-06 @ 4:08 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04883151
Status:
UNKNOWN
Last Update Posted:
2021-07-02
First Post:
2021-04-27
Brief Title:
A Psychological Intervention for Families in Pediatric Palliative Care
Sponsor:
Danish Cancer Society
Organization:
Danish Cancer Society
Study Overview
Official Title:
The SOFUS Psychological Intervention for Families With Children in Pediatric Palliative Care - a Pilot Study
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOFUS
Brief Summary:
Families of children receiving pediatric palliative care report unmet needs that require support The objective of this pilot study is to develop and evaluate a psychological intervention SOFUS that targets the whole family ie parents the ill child and siblings before and after bereavement The aim of the intervention is to improve coping skills and reduce symptoms of complicated grief depression anxiety and sleep disorders in families Feasibility and acceptability of the intervention manual and study materials will be evaluated and the preliminary efficacy of the intervention will be assessed
Detailed Description:
Having a child in palliative care is a traumatic experience and families of children receiving pediatric palliative care report unmet needs that require support Parents who experience the death of a child often experience severe grief reactions which may develop into long-term impaired functioning or psychiatric illness with a detrimental impact on the whole family Furthermore parents and siblings of a child in palliative care may already prior to death experience grief and loss This indicates the need for a family-based intervention that can support the family before and after the death of a child
SOFUS is a psychological intervention for families of children receiving pediatric palliative care team The preliminarypilot program has been manualized and consists of a pre-loss program Program 1 and a post-loss program Program 2 consisting of six sessions each designed for the whole family Sessions 1 and 6 includes the whole family sessions 2 and 3 focus on the parents while sessions 4 and 5 target the children with parents if the child is under 10 years old The six sessions range from 1 to 15 hours in length and are to be delivered over a 3 month period The intervention will be carried out by trained psychologists Feasibility and fidelity will assessed by evaluation forms filled out by the therapist after each session
At the end of the intervention semi-structured interviews will be carried out with each family to evaluate the components of the intervention participant materials and assess acceptability A semi-structured interview will also be carried out with the psychologists to evaluate the components of the intervention the intervention manual and to assess therapist acceptability of the intervention This pilot study will also include questionnaires for the parents assessing the outcomes of coping anxiety depression sleep quality family functioning and family caregiving burden at baseline 3 6 and 12 months Age-adapted questionnaires will be given to the children to assess a subset of the outcomes
SOFUS is a psychological intervention for families of children receiving pediatric palliative care team The preliminarypilot program has been manualized and consists of a pre-loss program Program 1 and a post-loss program Program 2 consisting of six sessions each designed for the whole family Sessions 1 and 6 includes the whole family sessions 2 and 3 focus on the parents while sessions 4 and 5 target the children with parents if the child is under 10 years old The six sessions range from 1 to 15 hours in length and are to be delivered over a 3 month period The intervention will be carried out by trained psychologists Feasibility and fidelity will assessed by evaluation forms filled out by the therapist after each session
At the end of the intervention semi-structured interviews will be carried out with each family to evaluate the components of the intervention participant materials and assess acceptability A semi-structured interview will also be carried out with the psychologists to evaluate the components of the intervention the intervention manual and to assess therapist acceptability of the intervention This pilot study will also include questionnaires for the parents assessing the outcomes of coping anxiety depression sleep quality family functioning and family caregiving burden at baseline 3 6 and 12 months Age-adapted questionnaires will be given to the children to assess a subset of the outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None