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A Psychological Intervention for Families in Pediatric Palliative Care

NCT04883151 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2021-07-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Copenhagen University Hospital at Herlev

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • Danish Cancer Society

    lead OTHER

Principal Investigators

  • Pernille Bidstrup, PhD · Danish Cancer Society Research Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-02
Primary Completion
2022-05-31
Completion
2023-05-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04883151 on ClinicalTrials.gov