Quality of LifeNCT05808114
Quality of Life in Children With Psychiatric Disorders and Parental Well-being: Effects of Group CBT
A study testing Friends program and TAU in people with Quality of Life, run by Helsinki University Central Hospital.
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. Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Quality of Life
- What is being tested?
- Friends program and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child psychiatric outpatient care
- sufficient skills to participate in group sessions
Who cannot join
- child psychiatric inpatient care
- acute suicidality
- excessive physical aggression
About this study
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.
- Conditions
- Quality of Life
- Being tested
- Friends program, TAU
- Keywords
- Quality of life, Health-related quality of life, Children, cognitive behavioral therapy, group cognitive behavioral therapy, parental wellbeing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Friends programBehavioural
A GCBT intervention comprising ten weekly 60-minute sessions followed by two booster sessions
TAUBehavioural
Individually tailored and delivered specialized child psychiatric care
| Study group | Role | What they receive |
|---|---|---|
| Group cognitive behavioral therapy | Experimental | Friends Program Receives: Behavioral: Friends program |
| Treatment as Usual | Experimental | A TAU condition during which participants received routine care services tailored to each child individually. Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
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
Measured: Before and after TAU (duration circa 3.2 months)
Secondary outcomes (3)
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
Measured: 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)
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
Measured: 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)
Parental sleep disturbance measured using the four- item Jenkins Sleep Questionnaire. Scores range from 0-20 with higher scores indicating greater sleep disturbance
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start1 Jul 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarianna Barron-Linnankoski, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808114
- Sponsor's protocol ID
- HUS/2699/2018
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2023
- Last updated
- 11 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Children With Psychiatric Disorders and Parental Well-being: Effects of Group CBT
- ClinicalTrials.gov ID
- NCT05808114
- Acronym / sponsor ID
- HUS/2699/2018
- Conditions
- Quality of Life
- Keywords
- Quality of life, Health-related quality of life, Children, cognitive behavioral therapy, group cognitive behavioral therapy, parental wellbeing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group cognitive behavioral therapy | Experimental | Behavioral: Friends programFriends Program |
| Treatment as Usual | Experimental | Behavioral: TAUA TAU condition during which participants received routine care services tailored to each child individually. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- child psychiatric outpatient care
- sufficient skills to participate in group sessions
Key exclusion criteria (3 listed)
- child psychiatric inpatient care
- acute suicidality
- excessive physical aggression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Friends programA GCBT intervention comprising ten weekly 60-minute sessions followed by two booster sessions | Behavioural | Group cognitive behavioral therapy |
| TAUIndividually tailored and delivered specialized child psychiatric care | Behavioural | Treatment as Usual |
Primary outcome
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
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Friends program and TAU in people with Quality of Life, run by Helsinki University Central Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.