search
Back to results

Effectiveness of Group CBT in Children With Mixed Psychiatric Disorders

Primary Purpose

Child Behavior Problem

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The Friends program
TAU condition
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Child Behavior Problem focused on measuring children, group cognitive behavioral therapy, cognitive behavioral therapy, internalizing symptoms, externalizing symptoms

Eligibility Criteria

6 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    group cognitive behavioral therapy intervention

    Treatment as usual (TAU)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in parent- and teacher rated internalizing and externalizing symptoms
    The Child Behavior Check List (CBCL) and the Teacher´s Report Form (TRF)

    Secondary Outcome Measures

    Full Information

    First Posted
    August 26, 2022
    Last Updated
    August 29, 2022
    Sponsor
    Helsinki University Central Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05519943
    Brief Title
    Effectiveness of Group CBT in Children With Mixed Psychiatric Disorders
    Official Title
    Effectiveness of Group CBT on Internalizing and Externalizing Symptoms in Children With Mixed Psychiatric Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2016 (Actual)
    Primary Completion Date
    October 1, 2019 (Actual)
    Study Completion Date
    October 1, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Helsinki University Central Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Child Behavior Problem
    Keywords
    children, group cognitive behavioral therapy, cognitive behavioral therapy, internalizing symptoms, externalizing symptoms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    103 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    group cognitive behavioral therapy intervention
    Arm Type
    Experimental
    Arm Title
    Treatment as usual (TAU)
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    The Friends program
    Intervention Description
    A GCBT intervention comprising ten weekly 60-minute sessions followed by two booster sessions
    Intervention Type
    Behavioral
    Intervention Name(s)
    TAU condition
    Intervention Description
    A TAU waitlist condition during which participants received routine care services tailored to each child individually.
    Primary Outcome Measure Information:
    Title
    Change in parent- and teacher rated internalizing and externalizing symptoms
    Description
    The Child Behavior Check List (CBCL) and the Teacher´s Report Form (TRF)
    Time Frame
    From referral to GCBT to 6-month follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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).

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effectiveness of Group CBT in Children With Mixed Psychiatric Disorders

    We'll reach out to this number within 24 hrs