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

Primary Purpose

Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Friends program
TAU
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quality of Life focused on measuring Quality of life, Health-related quality of life, Children, cognitive behavioral therapy, group cognitive behavioral therapy, parental wellbeing

Eligibility Criteria

6 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Group cognitive behavioral therapy

    Treatment as Usual

    Arm Description

    Friends Program

    A TAU condition during which participants received routine care services tailored to each child individually.

    Outcomes

    Primary Outcome Measures

    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
    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

    Secondary Outcome Measures

    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
    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
    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

    Full Information

    First Posted
    March 15, 2023
    Last Updated
    March 29, 2023
    Sponsor
    Helsinki University Central Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05808114
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2016 (Actual)
    Primary Completion Date
    December 31, 2019 (Actual)
    Study Completion Date
    December 31, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Helsinki University Central Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Quality of Life
    Keywords
    Quality of life, Health-related quality of life, Children, cognitive behavioral therapy, group cognitive behavioral therapy, parental wellbeing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    109 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group cognitive behavioral therapy
    Arm Type
    Experimental
    Arm Description
    Friends Program
    Arm Title
    Treatment as Usual
    Arm Type
    Experimental
    Arm Description
    A TAU condition during which participants received routine care services tailored to each child individually.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Friends program
    Intervention Description
    A GCBT intervention comprising ten weekly 60-minute sessions followed by two booster sessions
    Intervention Type
    Behavioral
    Intervention Name(s)
    TAU
    Intervention Description
    Individually tailored and delivered specialized child psychiatric care
    Primary Outcome Measure Information:
    Title
    Changes in self-and parent-rated health-related quality of life after the group cognitive behavior therapy (GCBT) intervention
    Description
    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
    Time Frame
    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
    Title
    Changes in self-and parent-rated health-related quality of life after treatment as usual (TAU)
    Description
    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
    Time Frame
    Before and after TAU (duration circa 3.2 months)
    Secondary Outcome Measure Information:
    Title
    Associations among children´s health-related quality of life and parental well-being dimensions
    Description
    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
    Time Frame
    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
    Title
    Associations among children´s HRQOL and parental well-being dimensions (parental psychological distress)
    Description
    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
    Time Frame
    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
    Title
    Associations among children´s HRQOL and parental well-being dimensions (parental sleep disturbance)
    Description
    Parental sleep disturbance measured using the four- item Jenkins Sleep Questionnaire. Scores range from 0-20 with higher scores indicating greater sleep disturbance
    Time Frame
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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