A Psychological Intervention for Families in Pediatric Palliative Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-02

Study Completion Date

2023-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Distress, Emotional Grief

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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SOFUS pilot program

Group Type EXPERIMENTAL

SOFUS pilot program

Intervention Type BEHAVIORAL

The SOFUS pilot program consists of six pre-loss sessions (Program 1) and a further six post-loss sessions (Program 2), which are delivered over a 3-month period. Each session ranges from 1-1.5 hours. 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 \<10 years old).

SOFUS consists of three primary components: i) strengthening COMMUNICATION between parents and children, ii) NORMALIZATION of grief processes (pre and post-lost), and iii) EMOTION REGULATION strategies targeting motivational awareness and regulatory skills in grief management (pre and post-lost).

Families in Program 1 may be offered Program 2 if the child dies before the entire program has been delivered.

Interventions

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SOFUS pilot program

The SOFUS pilot program consists of six pre-loss sessions (Program 1) and a further six post-loss sessions (Program 2), which are delivered over a 3-month period. Each session ranges from 1-1.5 hours. 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 \<10 years old).

SOFUS consists of three primary components: i) strengthening COMMUNICATION between parents and children, ii) NORMALIZATION of grief processes (pre and post-lost), and iii) EMOTION REGULATION strategies targeting motivational awareness and regulatory skills in grief management (pre and post-lost).

Families in Program 1 may be offered Program 2 if the child dies before the entire program has been delivered.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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