Distress, EmotionalSOFUSNCT04883151
A Psychological Intervention for Families in Pediatric Palliative Care
A study testing SOFUS pilot program in people with Distress, Emotional and Grief, run by Danish Cancer Society at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distress, Emotional, Grief
- What is being tested?
- SOFUS pilot program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Jun 2021to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any untreated psychiatric disorder or substance abuse in the family that may hinder participation in the program
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen
Julie H Rasmussen, julie.hoegh.rasmussen@regionh.dk
About this study
Official title: 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.
Read the 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.
- Conditions
- Distress, Emotional, Grief
- Being tested
- SOFUS pilot program
- Keywords
- Pediatric palliative care, Family intervention, Emotion regulation, Grief intervention
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOFUS pilot programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SOFUS pilot program | Experimental | Not described Receives: Behavioral: SOFUS pilot program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-intervention (3 months)
Secondary outcomes (12)
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Between baseline and 3 months, 6 months, 12 months, respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start2 Jun 2021
- Primary completionMay 2022 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distress, EmotionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Cancer Society
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital at Herlev, Aarhus University Hospital
- Responsible party
- Principal investigator, Pernille Bidstrup, Danish Cancer Society
- Investigators
- Pernille Bidstrup, PhD, Principal investigator, Danish Cancer Society Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883151
- Sponsor's protocol ID
- SOFUS
- Acronym
- SOFUS
- Status last verified
- Jul 2021
- First submitted
- 27 Apr 2021
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SOFUS Psychological Intervention for Families With Children in Pediatric Palliative Care - a Pilot Study
- ClinicalTrials.gov ID
- NCT04883151
- Acronym / sponsor ID
- SOFUS / SOFUS
- Conditions
- Distress, Emotional, Grief
- Keywords
- Pediatric palliative care, Family intervention, Emotion regulation, Grief intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Danish Cancer SocietyUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital at Herlev, Aarhus University Hospital
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOFUS pilot program | Experimental | Behavioral: SOFUS pilot program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Any untreated psychiatric disorder or substance abuse in the family that may hinder participation in the program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOFUS pilot programThe 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. | Behavioural | SOFUS pilot program |
Primary outcome
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
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.
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.
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.
12 secondary outcomes
Change in coping strategies in parents and children above 12 years
Time frame: 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
Change in symptoms of grief in parents and children above 12 years
Time frame: 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
Change in symptoms of depression in parents and children above 12
Time frame: 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
Change in symptoms of depression in children 6-12 years old
Time frame: 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
Change in emotion regulation in parents
Time frame: 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
Change in family functioning in parents and children above 12 years
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pernille Bidstrup, PhD principal investigator
Danish Cancer Society Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOFUS pilot program in people with Distress, Emotional and Grief, run by Danish Cancer Society at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beverley Lim Høeg, PhD (35257299, bevlim@cancer.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction assessed by questionnaire items constructed for this study (time frame: Post-intervention (3 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.