A Psychological Intervention for Families in Pediatric Palliative Care

NCT04883151 | Unknown

• 1 other identifier: SOFUS
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Distress, Emotional; Grief

Keywords

Pediatric palliative care; Family intervention; Emotion regulation; Grief intervention

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• Change in coping strategies in parents and children above 12 years

  Between baseline and 3 months, 6 months, 12 months, respectively

• Change in coping strategies in children 6-12 years old

  Between baseline and 3 months, 6 months, 12 months, respectively

• Change in symptoms of grief in parents and children above 12 years

  Between baseline and 3 months, 6 months, 12 months, respectively

• Change in symptoms of anxiety in parents and children above 12 years

  Between baseline and 3 months, 6 months, 12 months, respectively

• Change in symptoms of depression in parents and children above 12

  Between baseline and 3 months, 6 months, 12 months, respectively

Study Arms (1)

SOFUS pilot program

EXPERIMENTAL

Behavioral: SOFUS pilot program

Interventions

SOFUS pilot program BEHAVIORAL

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.

SOFUS pilot program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Any untreated psychiatric disorder or substance abuse in the family that may hinder participation in the program

Sponsors & Collaborators

• Danish Cancer Society: lead
• Copenhagen University Hospital at Herlev: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

RECRUITING

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Officials

• Pernille Bidstrup, PhD

  Danish Cancer Society Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beverley Lim Høeg, PhD

CONTACT

35257299; bevlim@cancer.dk

Pernille Bidstrup, PhD

CONTACT

35257600; pernille@cancer.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher and group leader

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 12, 2021
• Study Start: June 2, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2023
• Last Updated: July 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)