Clinical trial NCT05808114: Quality of Life in Children With Psychiatric Disorders and Parental Well-being: Effects of Group CBT
Official title: Quality of Life in Children With Psychiatric Disorders and Parental Well-being: Effects of Group CBT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Keywords: Quality of life
Health-related quality of life
Children
cognitive behavioral therapy
group cognitive behavioral therapy
parental wellbeing
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 109
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examines the immediate and long-term effectiveness of a group cognitive behavioral therapy intervention (GCBT) in improving health-related quality of life (HRQOL) in children treated for mixed psychiatric disorders in naturalistic child psychiatric outpatient settings. The effects of a treatment-as-usual condition (TAU) is also examined. Further, the study aims to explore the associations among children´s HRQOL dimensions and parental well-being, and how GCBT may influence these associations.

Detailed description: The effectiveness of GCBT and TAU at the different time points are measured using nonparametric tests, such as Friedman tests and Wilcoxon tests. The associations among children´s HRQOL dimensions and parental well-being variables at different time points are explored using a network analysis approach.

Eligibility criteria: Inclusion Criteria:

* child psychiatric outpatient care
* sufficient skills to participate in group sessions

Exclusion Criteria:

* child psychiatric inpatient care
* acute suicidality
* excessive physical aggression

Primary outcomes:
measure: Changes in self-and parent-rated health-related quality of life after the group cognitive behavior therapy (GCBT) intervention
timeFrame: Before and after the group cognitive behavioral intervention (duration from pre-GCBT to post-GCBT circa 4.7 months), and at a 7-month follow-up
measure: Changes in self-and parent-rated health-related quality of life after treatment as usual (TAU)
timeFrame: Before and after TAU (duration circa 3.2 months)
Secondary outcomes:
measure: Associations among children´s health-related quality of life and parental well-being dimensions
timeFrame: Before and after the group cognitive behavioral intervention (duration from pre-GCBT to post-GCBT circa 4.7 months), and at a 7-month follow-up
measure: Associations among children´s HRQOL and parental well-being dimensions (parental psychological distress)
timeFrame: Before and after the group cognitive behavioral intervention (duration from pre-GCBT to post-GCBT circa 4.7 months), and at a 7-month follow-up
measure: Associations among children´s HRQOL and parental well-being dimensions (parental sleep disturbance)
timeFrame: Before and after the group cognitive behavioral intervention (duration from pre-GCBT to post-GCBT circa 4.7 months), and at a 7-month follow-up
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