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

March 29, 2023 updated by: Sarianna Barron-Linnankoski, Helsinki University Central Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

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
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
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)
Time Frame: Before and after TAU (duration circa 3.2 months)
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
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
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)
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
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)
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

March 29, 2023

First Posted (Actual)

April 11, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

March 29, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUS/2699/2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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