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

July 1, 2021 updated by: Pernille Bidstrup, Danish Cancer Society

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Satisfaction assessed by questionnaire items constructed for this study
Time Frame: Post-intervention (3 months)
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
Time Frame: Post-intervention (3 months)
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
Time Frame: After each session
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
Time Frame: Post-intervention (3 months)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in coping strategies in parents and children above 12 years
Time Frame: Between baseline and 3 months, 6 months, 12 months, respectively
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
Time Frame: Between baseline and 3 months, 6 months, 12 months, respectively
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
Time Frame: Between baseline and 3 months, 6 months, 12 months, respectively
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
Time Frame: Between baseline and 3 months, 6 months, 12 months, respectively
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
Time Frame: Between baseline and 3 months, 6 months, 12 months, respectively
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
Time Frame: Between baseline and 3 months, 6 months, 12 months, respectively
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
Time Frame: Between baseline and 3 months, 6 months, 12 months, respectively
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
Time Frame: Between baseline and 3 months, 6 months, 12 months, respectively
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
Time Frame: Between baseline and 3 months, 6 months, 12 months, respectively
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
Time Frame: Between baseline and 3 months, 6 months, 12 months, respectively
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
Time Frame: Between baseline and 3 months, 6 months, 12 months, respectively
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
Time Frame: Between baseline and 3 months, 6 months, 12 months, respectively
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Danish Cancer Society

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aarhus University Hospital
Copenhagen University Hospital at Herlev

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pernille Bidstrup, PhD, Danish Cancer Society Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 2, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Distress, Emotional

Clinical Trials on SOFUS pilot program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings