Quality of Life in Children With Psychiatric Disorders and Parental Well-being: Effects of Group CBT

Study Overview
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Brief Summary
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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
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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.

Official Title
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Quality of Life in Children With Psychiatric Disorders and Parental Well-being: Effects of Group CBT

Conditions
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Quality of Life

Intervention / Treatment
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* Behavioral: Friends program
* Behavioral: TAU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: child psychiatric outpatient care sufficient skills to participate in group sessions Exclusion Criteria: child psychiatric inpatient care acute suicidality excessive physical aggression

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group cognitive behavioral therapy<br>Friends Program | Behavioral: Friends program<br>* A GCBT intervention comprising ten weekly 60-minute sessions followed by two booster sessions<br>|
| Experimental: Treatment as Usual<br>A TAU condition during which participants received routine care services tailored to each child individually. | Behavioral: TAU<br>* Individually tailored and delivered specialized child psychiatric care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in self-and parent-rated health-related quality of life after the group cognitive behavior therapy (GCBT) intervention | Children´s health-related quality of life measured using the KINDL-R measure, total scores range from 0-100 with higher scores indicating better health-related quality of life | 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 | 
| Changes in self-and parent-rated health-related quality of life after treatment as usual (TAU) | Children´s health-related quality of life measured using the KINDL-R measure, total scores range from 0-100 with higher scores indicating better health-related quality of life | Before and after TAU (duration circa 3.2 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Associations among children´s health-related quality of life and parental well-being dimensions | Children´s health-related quality of life measured using the KINDL-R measure, total scores range from 0-100 with higher scores indicating better health-related quality of life | 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 | 
| Associations among children´s HRQOL and parental well-being dimensions (parental psychological distress) | Parental psychological distress measured using five items of the 12-item General Health Questionnaire. The sum of the items range from 5-20 with higher scores indicating greater psychological distress | 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 | 
| Associations among children´s HRQOL and parental well-being dimensions (parental sleep disturbance) | Parental sleep disturbance measured using the four- item Jenkins Sleep Questionnaire. Scores range from 0-20 with higher scores indicating greater sleep disturbance | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life, Health-related quality of life, Children, cognitive behavioral therapy, group cognitive behavioral therapy, parental wellbeing