A Psychological Intervention for Families in Pediatric Palliative Care

Distress, Emotional Clinical Trial

— SOFUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04883151
• Other study ID #: SOFUS
• Status: Recruiting
• Phase: N/A
• Start date: June 2, 2021
• Est. completion date: May 2023

Study information

• Verified date: July 2021
• Source: Danish Cancer Society
• Contact: Beverley Lim Høeg, PhD
• Phone: 35257299
• Email: bevlim[@]cancer.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: May 2023
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Distress, Emotional
• Grief

Intervention

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.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Danish Cancer Society	Aarhus University Hospital, Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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