A Psychological Intervention for Families in Pediatric Palliative Care (SOFUS)

The SOFUS Psychological Intervention for Families With Children in Pediatric Palliative Care - a Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Distress, Emotional; Grief
• Intervention / Treatment: Behavioral: SOFUS pilot program

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.

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beverley Lim Høeg, PhD; Phone Number: 35257299; Email: bevlim@cancer.dk
• Study Contact Backup: Name: Pernille Bidstrup, PhD; Phone Number: 35257600; Email: pernille@cancer.dk

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Recruiting
    • Rigshospitalet
    • Contact: Julie H Rasmussen; Email: julie.hoegh.rasmussen@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SOFUS pilot program

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction assessed by questionnaire items constructed for this study	Measured by 9 study-specific items assessing parental satisfaction with the intervention's materials, the therapist and the intervention's focus on family/child-related factors; score range 0-27; higher scores = higher satisfaction	Post-intervention (3 months)
Satisfaction assessed by interview items constructed for this study	Assessed through open-ended interview items evaluating the family's satisfaction with the following: 1) motivation and barriers to participation, 2) format of the intervention, 3) video and written materials of the intervention, and 4) intervention components related to the children.	Post-intervention (3 months)
Feasibility assessed by questionnaire items constructed for this study	Measured by items assessing whether the therapist carried out each section of the manualized session and whether the time allotted was sufficient. Section scores range from 0-12, with higher scores indicating higher feasibility.	After each session
Feasibility assessed by interview items constructed for this study	Assessed through open-ended interview items evaluating the the following: 1) recruitment procedures, 2) format of the intervention, 3) focus areas of intervention, 4) the intervention manual, and 5) the intervention materials for the families.	Post-intervention (3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in coping strategies in parents and children above 12 years	Measured by the 28-item Brief COPE Inventory consisting of 14 subscales (Self-distraction, Active coping, Denial, Substance use, Use of emotional support, Use of instrumental support, Behavioral disengagement, Venting, Positive reframing, Planning, Humor, Acceptance, Religion, and Self-blame). Scores are reported for each subscale; score range 2-8; higher scores = higher use of this specific coping strategy	Between baseline and 3 months, 6 months, 12 months, respectively
Change in coping strategies in children 6-12 years old	Measured by the 15-item KidCope assessing the frequency (whether the child used the strategy) and efficacy (whether it helped) of 11 types of coping strategies (4 adaptive coping = problem solving, positive emotion regulation, cognitive restructuring, seeking social support; 7 maladaptive coping = distraction, negative emotion regulation, social withdrawal, wishful thinking, self-criticism, blaming others, resignation). Scores are reported for each coping strategy. Frequency is assessed by 1=Yes/0=No and efficacy is assessed on a scale from 0 (Not at all) to 2 (A-lot). Higher scores reflect greater use and/or perceived helpfulness of the indicated coping strategy or type of coping	Between baseline and 3 months, 6 months, 12 months, respectively
Change in symptoms of grief in parents and children above 12 years	Measured by the 13-item Prolonged Grief-13 (PG-13), the pre-loss PG-13 will be used for families in Program 1. The duration and impairment items are assessed by Yes/No and score range for the remaining 11 multiple choice items = 11-44; higher scores = higher grief symptoms.	Between baseline and 3 months, 6 months, 12 months, respectively
Change in symptoms of anxiety in parents and children above 12 years	Measured by the 7-item Generalized Anxiety Disorder-7 (GAD-7); range 0-21; higher scores = more symptoms	Between baseline and 3 months, 6 months, 12 months, respectively
Change in symptoms of depression in parents and children above 12	Measured by the 9-item Patient Health Questionnaire-9 (PHQ-9); range 0-27; higher scores = more symptoms	Between baseline and 3 months, 6 months, 12 months, respectively
Change in symptoms of depression in children 2-5 years old	Measured by the 21-item Pediatric Emotional Distress Scale (PEDS); range 21-84; higher scores = more symptoms	Between baseline and 3 months, 6 months, 12 months, respectively
Change in symptoms of depression in children 6-12 years old	Measured by the 25-item Strengths and Difficulties Questionnaire (SDQ), consisting of 5 subscales (Emotional symptoms, Conduct problems, Hyperactivity/inattention, Peer relationships problem, and Prosocial behaviour). Scores are reported for each subscale; score range 0-10. For the 4 difficulties subscales, higher scores = more difficulties; for the strength subscale, higher score = better social strength	Between baseline and 3 months, 6 months, 12 months, respectively
Change in sleep quality in parents only	Measured by the Pittsburgh Sleep Quality Index (PSQI); range 0-21; higher scores = worse sleep quality	Between baseline and 3 months, 6 months, 12 months, respectively
Change in emotion regulation in parents	Measured by the 36-item Cognitive Emotion Regulation Questionnaire (CERQ) consisting of 9 subscales (Self-blame, Blaming others, Acceptance, Refocusing on planning, Positive refocusing, Rumination, Positive reappraisal, Putting into perspective, and Catastrophizing); Scores are reported by subscale; score range 4-20; higher scores = greater use of the specific cognitive strategy	Between baseline and 3 months, 6 months, 12 months, respectively
Change in emotion regulation in children	Measured by six emotion thermometers (developed for the study) assessing guilt, jealousy, fear, happiness, sadness and anger; score range 1-10; higher scores = higher levels of emotion	Between baseline and 3 months, 6 months, 12 months, respectively
Change in family functioning in parents and children above 12 years	Measured by the Family Assessment Device (FAD) communication subscale (6 items) and general functioning subscale (12-items). Scores are reported by subscale; score range 1-4; higher scores = better family functioning	Between baseline and 3 months, 6 months, 12 months, respectively
Change in family caregiving burden in parents only	Measured by the 25-item Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC) consisting of 4 subscales (caregiver strain, positive caregiving appraisals, caregiver distress, and family well-being. Scores are reported by subscale; score range 1-5; higher scores = higher level on the specific subscale measure.	Between baseline and 3 months, 6 months, 12 months, respectively

Collaborators and Investigators

• Sponsor: Danish Cancer Society
• Collaborators: Aarhus University Hospital; Copenhagen University Hospital at Herlev
• Investigators: Principal Investigator: Pernille Bidstrup, PhD, Danish Cancer Society Research Center

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 12, 2021

Study Record Updates

• Last Update Posted (Actual): July 2, 2021
• Last Update Submitted That Met QC Criteria: July 1, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Emotion regulation; Pediatric palliative care; Family intervention; Grief intervention
• Other Study ID Numbers: SOFUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No