Clinical trial NCT04883151: A Psychological Intervention for Families in Pediatric Palliative Care
Official title: The SOFUS Psychological Intervention for Families With Children in Pediatric Palliative Care - a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Distress, Emotional
Grief
Keywords: Pediatric palliative care
Family intervention
Emotion regulation
Grief intervention
Lead sponsor: Danish Cancer Society
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital at Herlev
name: Aarhus University Hospital
First posted: 2021-05-12
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 (i.e. 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 preliminary/pilot 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 1.5 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.

Eligibility criteria: Inclusion Criteria:

* Parents of a child age between 6 months and 18 years referred to the palliative team for children and adolescents
* At least one parent \> 18 years
* Able to understand and speak Danish wish to participate
* Informed consent by at least one parent, and by both parents on behalf of any children participating

Exclusion Criteria:

- Any untreated psychiatric disorder or substance abuse in the family that may hinder participation in the program

Primary outcomes:
measure: Satisfaction assessed by questionnaire items constructed for this study
timeFrame: Post-intervention (3 months)
measure: Satisfaction assessed by interview items constructed for this study
timeFrame: Post-intervention (3 months)
measure: Feasibility assessed by questionnaire items constructed for this study
timeFrame: After each session
measure: Feasibility assessed by interview items constructed for this study
timeFrame: Post-intervention (3 months)
Secondary outcomes:
measure: Change in coping strategies in parents and children above 12 years
timeFrame: Between baseline and 3 months, 6 months, 12 months, respectively
measure: Change in coping strategies in children 6-12 years old
timeFrame: Between baseline and 3 months, 6 months, 12 months, respectively
measure: Change in symptoms of grief in parents and children above 12 years
timeFrame: Between baseline and 3 months, 6 months, 12 months, respectively
measure: Change in symptoms of anxiety in parents and children above 12 years
timeFrame: Between baseline and 3 months, 6 months, 12 months, respectively
measure: Change in symptoms of depression in parents and children above 12
timeFrame: Between baseline and 3 months, 6 months, 12 months, respectively
measure: Change in symptoms of depression in children 2-5 years old
timeFrame: Between baseline and 3 months, 6 months, 12 months, respectively
measure: Change in symptoms of depression in children 6-12 years old
timeFrame: Between baseline and 3 months, 6 months, 12 months, respectively
measure: Change in sleep quality in parents only
timeFrame: Between baseline and 3 months, 6 months, 12 months, respectively
measure: Change in emotion regulation in parents
timeFrame: Between baseline and 3 months, 6 months, 12 months, respectively
measure: Change in emotion regulation in children
timeFrame: Between baseline and 3 months, 6 months, 12 months, respectively
measure: Change in family functioning in parents and children above 12 years
timeFrame: Between baseline and 3 months, 6 months, 12 months, respectively
measure: Change in family caregiving burden in parents only
timeFrame: Between baseline and 3 months, 6 months, 12 months, respectively
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Danish Cancer Society Research Center
name: Pernille Bidstrup, PhD
role: PRINCIPAL_INVESTIGATOR
References: