- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05519943
Effectiveness of Group CBT in Children With Mixed Psychiatric Disorders
August 29, 2022 updated by: Sarianna Barron-Linnankoski, Helsinki University Central Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
103
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 13 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: group cognitive behavioral therapy intervention
|
A GCBT intervention comprising ten weekly 60-minute sessions followed by two booster sessions
|
|
Experimental: Treatment as usual (TAU)
|
A TAU waitlist condition during which participants received routine care services tailored to each child individually.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
From referral to GCBT to 6-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2016
Primary Completion (Actual)
October 1, 2019
Study Completion (Actual)
October 1, 2021
Study Registration Dates
First Submitted
August 26, 2022
First Submitted That Met QC Criteria
August 26, 2022
First Posted (Actual)
August 29, 2022
Study Record Updates
Last Update Posted (Actual)
August 30, 2022
Last Update Submitted That Met QC Criteria
August 29, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUS/211/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.