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Psychological Prevention of Internalizing Disorders

Primary Purpose

Anxiety Symptoms, Depressive Symptoms, Somatoform Symptoms

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cognitive Behavioral Group Therapy
Cognitive Behavioral Group Therapy
Sponsored by
Philipps University Marburg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety Symptoms

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 8- 12 years and
  • anxiety symptoms and/or
  • depressive symptoms and/or
  • somatoform symptoms

Exclusion Criteria:

  • psychiatric disorder according to ICD-10/ DSM-IV-TR requiring individual psychotherapy
  • IQ < 85

Sites / Locations

  • Institut für Verhaltenstherapie und -medizin (IVV)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

A

B

C

Arm Description

Outcomes

Primary Outcome Measures

Child Behavior Checklist (german version)

Secondary Outcome Measures

Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK)- Assessment of life quality, parent and child versions
Spence Children's Anxiety Scale (SCAS)
Depressionsinventar für Kinder- und Jugendliche (DIKJ), german depression inventory based on CDI
Giessener Beschwerdebogen für Kinder- und Jugendliche (GBB-KJ), report of somatic symptoms, parent and child versions
Culture Fair Intelligence Test (CFT 20-R)
Symptom-Checklist (SCL-90-R), german version

Full Information

First Posted
November 26, 2007
Last Updated
April 26, 2018
Sponsor
Philipps University Marburg Medical Center
Collaborators
Institute of Behavioral-Therapy and -Medicine at the Philipps University Marburg, Dept. of Child and Adolescent Psychiatry, Philipps University Marburg
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1. Study Identification

Unique Protocol Identification Number
NCT00564239
Brief Title
Psychological Prevention of Internalizing Disorders
Official Title
Efficacy of Child-centered Cognitive-Behavioral Prevention of Internalizing Disorders and the Impact of Simultaneous Parent Training
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Philipps University Marburg Medical Center
Collaborators
Institute of Behavioral-Therapy and -Medicine at the Philipps University Marburg, Dept. of Child and Adolescent Psychiatry, Philipps University Marburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether cognitive-behavioral group prevention (CBT-G) for german children is effective and to what extent parental group training moderates outcome.
Detailed Description
Internalizing disorders represent a large group of psychological disorders among children who are referred to psychological treatment. Anxiety, Depression and somatoform disorders in children and adolescents increase the risk of mental disorders in adulthood. Some english programs have proved the efficacy of CBT-G prevention.This study will test the efficacy of CBT-G in German children. The role of parental involvement is currently subject to scientific discussions. The impact of an additional parent-group training will be investigated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Symptoms, Depressive Symptoms, Somatoform Symptoms

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Active Comparator
Arm Title
C
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Group Therapy
Intervention Description
12 children group sessions, 8 parent group sessions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Group Therapy
Intervention Description
12 children group sessions
Primary Outcome Measure Information:
Title
Child Behavior Checklist (german version)
Time Frame
3, 6, 18 months
Secondary Outcome Measure Information:
Title
Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK)- Assessment of life quality, parent and child versions
Time Frame
3, 6, 18 months
Title
Spence Children's Anxiety Scale (SCAS)
Time Frame
3, 6, 18 months
Title
Depressionsinventar für Kinder- und Jugendliche (DIKJ), german depression inventory based on CDI
Time Frame
3, 6, 18 months
Title
Giessener Beschwerdebogen für Kinder- und Jugendliche (GBB-KJ), report of somatic symptoms, parent and child versions
Time Frame
3, 6, 18 months
Title
Culture Fair Intelligence Test (CFT 20-R)
Time Frame
initially
Title
Symptom-Checklist (SCL-90-R), german version
Time Frame
3, 6, 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 8- 12 years and anxiety symptoms and/or depressive symptoms and/or somatoform symptoms Exclusion Criteria: psychiatric disorder according to ICD-10/ DSM-IV-TR requiring individual psychotherapy IQ < 85
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Pauschardt, Dr.
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sylvia D Eimecke, Dr.
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fritz Mattejat, PhD
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Institut für Verhaltenstherapie und -medizin (IVV)
City
Marburg
State/Province
Hessen
ZIP/Postal Code
D-35039
Country
Germany

12. IPD Sharing Statement

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Psychological Prevention of Internalizing Disorders

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