Psychological Prevention of Internalizing Disorders

April 26, 2018 updated by: Jan Pauschardt, Philipps University Marburg Medical Center

Efficacy of Child-centered Cognitive-Behavioral Prevention of Internalizing Disorders and the Impact of Simultaneous Parent Training

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Marburg, Hessen, Germany, D-35039
        • Institut für Verhaltenstherapie und -medizin (IVV)

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

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B
Behavioral: Cognitive Behavioral Group Therapy
12 children group sessions, 8 parent group sessions
Behavioral: Cognitive Behavioral Group Therapy
12 children group sessions
Experimental: A
Behavioral: Cognitive Behavioral Group Therapy
12 children group sessions, 8 parent group sessions
Behavioral: Cognitive Behavioral Group Therapy
12 children group sessions
No Intervention: C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Child Behavior Checklist (german version)
Time Frame: 3, 6, 18 months
3, 6, 18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK)- Assessment of life quality, parent and child versions
Time Frame: 3, 6, 18 months
3, 6, 18 months
Spence Children's Anxiety Scale (SCAS)
Time Frame: 3, 6, 18 months
3, 6, 18 months
Depressionsinventar für Kinder- und Jugendliche (DIKJ), german depression inventory based on CDI
Time Frame: 3, 6, 18 months
3, 6, 18 months
Giessener Beschwerdebogen für Kinder- und Jugendliche (GBB-KJ), report of somatic symptoms, parent and child versions
Time Frame: 3, 6, 18 months
3, 6, 18 months
Culture Fair Intelligence Test (CFT 20-R)
Time Frame: initially
initially
Symptom-Checklist (SCL-90-R), german version
Time Frame: 3, 6, 18 months
3, 6, 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Investigators

  • Principal Investigator: Jan Pauschardt, Dr., Philipps University Marburg Medical Center
  • Principal Investigator: Sylvia D Eimecke, Dr., Philipps University Marburg Medical Center
  • Study Director: Fritz Mattejat, PhD, Philipps University Marburg Medical Center

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

November 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

November 26, 2007

First Submitted That Met QC Criteria

November 26, 2007

First Posted (Estimate)

November 27, 2007

Study Record Updates

Last Update Posted (Actual)

April 30, 2018

Last Update Submitted That Met QC Criteria

April 26, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVV-001-2007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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