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

• Sponsor: Helsinki University Central Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05808114
• Collaborator: (none)
• Enrollment: 109
• Arms: 2
• Actual Duration (Months): 42

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Quality of Life	Behavioral: Friends program; Behavioral: TAU	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 109 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Quality of Life in Children With Psychiatric Disorders and Parental Well-being: Effects of Group CBT
• Actual Study Start Date: Jul 1, 2016
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Dec 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Changes in self-and parent-rated health-related quality of life after the group cognitive behavior therapy (GCBT) intervention [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

2. Changes in self-and parent-rated health-related quality of life after treatment as usual (TAU) [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

Secondary Outcome Measures

1. Associations among children´s health-related quality of life and parental well-being dimensions [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

2. Associations among children´s HRQOL and parental well-being dimensions (parental 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]

   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

3. Associations among children´s HRQOL and parental well-being dimensions (parental 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]

   Parental sleep disturbance measured using the four- item Jenkins Sleep Questionnaire. Scores range from 0-20 with higher scores indicating greater sleep disturbance

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 13 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• child psychiatric outpatient care

• sufficient skills to participate in group sessions

Exclusion Criteria:

• child psychiatric inpatient care

• acute suicidality

• excessive physical aggression

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Helsinki University Central Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sarianna Barron-Linnankoski, Principal Investigator, Helsinki University Central Hospital
• ClinicalTrials.gov Identifier: NCT05808114
• Other Study ID Numbers: HUS/2699/2018
• First Posted: Apr 11, 2023
• Last Update Posted: Apr 11, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sarianna Barron-Linnankoski, Principal Investigator, Helsinki University Central Hospital: Quality of life; Health-related quality of life; Children; cognitive behavioral therapy; group cognitive behavioral therapy; parental wellbeing
• Additional relevant MeSH terms: Mental Disorders; Problem Behavior

Study Results

No Results Posted as of Apr 11, 2023