None listed
Conditions
Brief summary
Background: Diagnosis of chronic disease in a child can result in unresolved grief (UG) in parents. Aims: to evaluate efficacy of psychological insight-oriented therapy (IOT) as a treatment for UG compared to disease related education in parents of children with cystic fibrosis (CF). Sequence of delivery, first IOT then disease related education (or vice versa) also examined, to let all participants experience both interventions. Methods: Parents screened for UG. Parents with UG randomised to either five one-hour sessions of IOT or five one-hour sessions of education. Measures assessed pre-intervention, after the first intervention period (primary efficacy assessment), and after the second intervention period (swapping intervention). Primary outcome measure: resolution of grief as measured by the Reaction to Diagnosis Interview. Secondary outcome measures: Anxiety, Stress, Depression as measured by the Depression, Anxiety, Stress Scale (DASS), and the Parent Stress Index (PSI).
Interventions
Intervention One (insight-oriented therapy; IOT): five one-hour sessions of IOT spread out within a minimum of five weeks. For pragmatic reasons and to maximise participation, no specific maximum timeframe indicated between measurement of unresolved grief (UG) and the study interventions. Participants will only move to the next part of the study after all five one-hour IOT sessions have been completed.
What is involved in the IOT: One-on-one sessions with a clinical psychologist delivering IO
Intervention One (insight-oriented therapy; IOT): five one-hour sessions of IOT spread out within a minimum of five weeks. For pragmatic reasons and to maximise participation, no specific maximum timeframe indicated between measurement of unresolved grief (UG) and the study interventions. Participants will only move to the next part of the study after all five one-hour IOT sessions have been completed. What is involved in the IOT: One-on-one sessions with a clinical psychologist delivering IOT focused on assisting parents to gain a deeper understanding of the impact of their unresolved grief (UG) surrounding their child’s diagnosis on their day-to-day coping, their interpersonal relationships, and their distress surrounding the future of their child with the aim of bringing about psychological change which would lead to a sense of resolution in relation to their child’s CF diagnosis. Mode of therapy: one-on-one in-person session with a clinical psychologist Strategies to monitor adherence: Participants will only move to the next part of the study after all five one-hour IOT sessions have been completed. After the above, outcomes measured and participants exposed to Intervention Two (comparator treatment described below)
Sponsors
Princess Margaret Hospital for Children
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Parent of a child with cystic fibrosis aged 6 months - 18 years with unresolved grief as diagnosed with Reaction to Diagnosis Interview
Exclusion criteria
Living in a geographical location too far from the hospital (study site) to allow participation in the study.
Outcome results
None listed