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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05808114
• Other study ID #: HUS/2699/2018
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2023
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 13 Years

Eligibility

Inclusion Criteria:

• child psychiatric outpatient care

• sufficient skills to participate in group sessions

Exclusion Criteria:

• child psychiatric inpatient care

• acute suicidality

• excessive physical aggression

Related Conditions & MeSH terms

• Mental Disorders
• Problem Behavior
• Quality of Life

Intervention

Behavioral:
• Friends program
A GCBT intervention comprising ten weekly 60-minute sessions followed by two booster sessions
• TAU
Individually tailored and delivered specialized child psychiatric care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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