Child Behavior ProblemNCT05519943
Effectiveness of Group CBT in Children With Mixed Psychiatric Disorders
A study testing The Friends program and TAU condition in people with Child Behavior Problem, run by Helsinki University Central Hospital.
Trial summary
This study aims to examine the immediate and longer-term effectiveness of a group cognitive behavioral therapy intervention (GCBT) in reducing internalizing and externalizing symptoms in children treated for mixed psychiatric disorders in naturalistic clinical settings. Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Child Behavior Problem
- What is being tested?
- The Friends program and TAU condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 1 Oct 2021
- 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
- Helsinki University Hospital child psychiatric outpatient clinic patients with symptoms of anxiety or depression, deficiencies in emotional and behavioral skills impairing functioning, and sufficient social and cognitive skills to participate in group work.
Who cannot join
- Helsinki University Hospital child psychiatric outpatient clinic patients with excessive physical aggression, excessive physical restlessness to enable skill training, or whose severity of psychiatric symptoms required individual psychotherapy (e.g., acute suicidality or psychosis).
About this study
Official title: Effectiveness of Group CBT on Internalizing and Externalizing Symptoms in Children With Mixed Psychiatric Disorders
This study aims to examine the immediate and longer-term effectiveness of a group cognitive behavioral therapy intervention (GCBT) in reducing internalizing and externalizing symptoms in children treated for mixed psychiatric disorders in naturalistic clinical settings. Further, the effectiveness of GCBT is compared to a treatment-as-usual condition (TAU). Within this study, it is hypothesized that children with mixed psychiatric disorders will exhibit improvements in parent-rated internalizing problem behavior and parent- and teacher-rated externalizing problem behavior following GCBT.
- Conditions
- Child Behavior Problem
- Being tested
- The Friends program, TAU condition
- Keywords
- children, group cognitive behavioral therapy, cognitive behavioral therapy, internalizing symptoms, externalizing symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Friends programBehavioural
A GCBT intervention comprising ten weekly 60-minute sessions followed by two booster sessions
TAU conditionBehavioural
A TAU waitlist condition during which participants received routine care services tailored to each child individually.
| Study group | Role | What they receive |
|---|---|---|
| group cognitive behavioral therapy intervention | Experimental | Not described Receives: Behavioral: The Friends program |
| Treatment as usual (TAU) | Experimental | Not described Receives: Behavioral: TAU condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in parent- and teacher rated internalizing and externalizing symptoms
The Child Behavior Check List (CBCL) and the Teacher´s Report Form (TRF)
Measured: From referral to GCBT to 6-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 posted29 Aug 2022
- Study start1 Jul 2016
- Primary completion1 Oct 2019
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Behavior ProblemStudies 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
- 103 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
- NCT05519943
- Sponsor's protocol ID
- HUS/211/2016
- Status last verified
- Aug 2022
- First submitted
- 26 Aug 2022
- Last updated
- 30 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Group CBT on Internalizing and Externalizing Symptoms in Children With Mixed Psychiatric Disorders
- ClinicalTrials.gov ID
- NCT05519943
- Acronym / sponsor ID
- HUS/211/2016
- Conditions
- Child Behavior Problem
- Keywords
- children, group cognitive behavioral therapy, cognitive behavioral therapy, internalizing symptoms, externalizing symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 29 Aug 2022 (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 aims to examine the immediate and longer-term effectiveness of a group cognitive behavioral therapy intervention (GCBT) in reducing internalizing and externalizing symptoms in children treated for mixed psychiatric disorders in naturalistic clinical settings. Further, the effectiveness of GCBT is compared to a treatment-as-usual condition (TAU). Within this study, it is hypothesized that children with mixed psychiatric disorders will exhibit improvements in parent-rated internalizing problem behavior and parent- and teacher-rated externalizing problem behavior following GCBT.
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 intervention | Experimental | Behavioral: The Friends program |
| Treatment as usual (TAU) | Experimental | Behavioral: TAU condition |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Helsinki University Hospital child psychiatric outpatient clinic patients with symptoms of anxiety or depression, deficiencies in emotional and behavioral skills impairing functioning, and sufficient social and cognitive skills to participate in group work.
Key exclusion criteria (1 listed)
- Helsinki University Hospital child psychiatric outpatient clinic patients with excessive physical aggression, excessive physical restlessness to enable skill training, or whose severity of psychiatric symptoms required individual psychotherapy (e.g., acute suicidality or psychosis).
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 |
|---|---|---|
| The Friends programA GCBT intervention comprising ten weekly 60-minute sessions followed by two booster sessions | Behavioural | group cognitive behavioral therapy intervention |
| TAU conditionA TAU waitlist condition during which participants received routine care services tailored to each child individually. | Behavioural | Treatment as usual (TAU) |
Primary outcome
Change in parent- and teacher rated internalizing and externalizing symptoms
Time frame: From referral to GCBT to 6-month follow-up
The Child Behavior Check List (CBCL) and the Teacher´s Report Form (TRF)
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 30 Aug 2022.
- Individual participant dataSharing planned: No
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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 The Friends program and TAU condition in people with Child Behavior Problem, 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 1 inclusion and 1 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 30 Aug 2022. 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?
Change in parent- and teacher rated internalizing and externalizing symptoms (time frame: From referral to GCBT to 6-month follow-up). 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 30 Aug 2022.