An interventional study of SOFUS pilot program in Distress, Emotional and Grief, sponsored by Danish Cancer Society. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-02.
Sponsored by Danish Cancer Society · Not applicable, Interventional, and Supportive care
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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.
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.
547 studies on the registry are indexed under Emotional Regulation; 190 are open to participants now.
This study's planned enrollment of 64 is below the median of 80 across 500 interventional studies indexed under Emotional Regulation.
Browse Emotional Regulation studies →Danish Cancer Society is the lead sponsor of 22 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Post-intervention (3 months)
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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Between baseline and 3 months, 6 months, 12 months, respectively
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2021 (actual). Primary completion is estimated for May 2022, 11 months after the start.
Of 391 non-industry interventional studies with no phase under Emotional Regulation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 11 months is below that.
Counting every sponsor, half of 397 studies reached it within 18 months; a quarter within 6 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Danish Cancer Society