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Completed

NCT Number: NCT05808114

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

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.

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Key information

Conditions

Quality of Life

Age range

6 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Friends program

Behavioral

A GCBT intervention comprising ten weekly 60-minute sessions followed by two booster sessions

TAU

Behavioral

Individually tailored and delivered specialized child psychiatric care

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 11, 2023
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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