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CompletedNCT05519943Updated Aug 30, 2022

Effectiveness of Group CBT in Children With Mixed Psychiatric Disorders

An interventional study of The Friends program and TAU condition in Child Behavior Problem, sponsored by Helsinki University Central Hospital. Completed. Open to participants aged 6 Years to 13 Years. Per ClinicalTrials.gov, last updated 2022-08-30.

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

From the registry’s dates

  • Registered 6 years 1 month after the study started (first participant enrolled Jul 2016, registered Aug 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
103
Allocation
Non-randomized
Ages
6 Years to 13 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Child Behavior Problem

Keywords

  • children
  • group cognitive behavioral therapy
  • cognitive behavioral therapy
  • internalizing symptoms
  • externalizing symptoms
03

In context

Lead sponsor

Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.

Browse Helsinki University Central Hospital studies →

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

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

Study arms

  • Experimental
    group cognitive behavioral therapy intervention

    Behavioral: The Friends program

  • Experimental
    Treatment as usual (TAU)

    Behavioral: TAU condition

Interventions

  • BehavioralThe Friends program

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

  • BehavioralTAU condition

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

06

What researchers measure

Primary outcomes

  1. Change in parent- and teacher rated internalizing and externalizing symptoms

    The Child Behavior Check List (CBCL) and the Teacher´s Report Form (TRF)

    Time frame: From referral to GCBT to 6-month follow-up

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2016 to primary completion in Oct 2019, 39 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2022
First posted
Aug 29, 2022
StartActual
Jul 1, 2016
Primary completionActual
Oct 1, 2019
CompletionActual
Oct 1, 2021
Last update
Aug 30, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05519943
Lead sponsor
Helsinki University Central Hospital
Responsible party
Sarianna Barron-Linnankoski (Principal Investigator, Helsinki University Central Hospital) — Principal investigator
First posted
Aug 29, 2022
Start date
Jul 1, 2016
Primary completion
Oct 1, 2019
Completion
Oct 1, 2021
Last update
Aug 30, 2022

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 Aug 2022. You cannot join it, but the record below documents what was studied.

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