CClinicalTrials.gg
CompletedNCT05808114Updated Apr 11, 2023

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

An interventional study of Friends program and TAU in Quality of Life, sponsored by Helsinki University Central Hospital. Completed. Open to participants aged 6 Years to 13 Years. Per ClinicalTrials.gov, last updated 2023-04-11.

Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 years 8 months after the study started (first participant enrolled Jul 2016, registered Mar 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
109
Allocation
Non-randomized
Ages
6 Years to 13 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Quality of Life

Keywords

  • Quality of life
  • Health-related quality of life
  • Children
  • cognitive behavioral therapy
  • group cognitive behavioral therapy
  • parental wellbeing
03

In context

Mental Disorders

2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.

This study's enrollment of 109 is above the median of 94 across 1,574 interventional studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

Helsinki University Central Hospital is the lead sponsor of 299 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • child psychiatric inpatient care
  • acute suicidality
  • excessive physical aggression
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
109 participants (actual)

Study arms

  • Experimental
    Group cognitive behavioral therapy

    Friends Program

    Behavioral: Friends program

  • Experimental
    Treatment as Usual

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

    Behavioral: TAU

Interventions

  • BehavioralFriends program

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

  • BehavioralTAU

    Individually tailored and delivered specialized child psychiatric care

06

What researchers measure

Primary outcomes

  1. 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

    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

  2. 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

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

Secondary outcomes

  1. 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

    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

  2. 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

    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

  3. 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

    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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05808114
Lead sponsor
Helsinki University Central Hospital
Responsible party
Sarianna Barron-Linnankoski (Principal Investigator, Helsinki University Central Hospital) — Principal investigator
First posted
Apr 11, 2023
Start date
Jul 1, 2016
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
Apr 11, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion