Psychological Prevention of Internalizing Disorders
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Philipps University Marburg Medical Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
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
Information provided by:
Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT00564239
First received: November 26, 2007
Last updated: August 27, 2010
Last verified: August 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anxiety Symptoms Depressive Symptoms Somatoform Symptoms |
Behavioral: Cognitive Behavioral Group Therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Efficacy of Child-centered Cognitive-Behavioral Prevention of Internalizing Disorders and the Impact of Simultaneous Parent Training |
Resource links provided by NLM:
Further study details as provided by Philipps University Marburg Medical Center:
Primary Outcome Measures:
- Child Behavior Checklist (german version) [ Time Frame: 3, 6, 18 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK)- Assessment of life quality, parent and child versions [ Time Frame: 3, 6, 18 months ] [ Designated as safety issue: No ]
- Spence Children's Anxiety Scale (SCAS) [ Time Frame: 3, 6, 18 months ] [ Designated as safety issue: No ]
- Depressionsinventar für Kinder- und Jugendliche (DIKJ), german depression inventory based on CDI [ Time Frame: 3, 6, 18 months ] [ Designated as safety issue: No ]
- Giessener Beschwerdebogen für Kinder- und Jugendliche (GBB-KJ), report of somatic symptoms, parent and child versions [ Time Frame: 3, 6, 18 months ] [ Designated as safety issue: No ]
- Culture Fair Intelligence Test (CFT 20-R) [ Time Frame: initially ] [ Designated as safety issue: No ]
- Symptom-Checklist (SCL-90-R), german version [ Time Frame: 3, 6, 18 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Behavioral: Cognitive Behavioral Group Therapy
12 children group sessions, 8 parent group sessions
|
| Active Comparator: B |
Behavioral: Cognitive Behavioral Group Therapy
12 children group sessions
|
| No Intervention: C |
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.
Eligibility| Ages Eligible for Study: | 8 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564239
Contacts
| Contact: Jan Pauschardt, Dr. | +49-6421-2863029 | pauschar@med.uni-marburg.de |
| Contact: Sylvia D Eimecke, Dr. | +49-6421-2863063 | eimecke@med.uni-marburg.de |
Locations
| Germany | |
| Institut für Verhaltenstherapie und -medizin (IVV) | Recruiting |
| Marburg, Hessen, Germany, D-35039 | |
| Contact: Ilse Karem, Secretary +49-6421-2866472 karem@med.uni-marburg.de | |
| Principal Investigator: Jan Pauschardt, DP (MA) | |
Sponsors and Collaborators
Philipps University Marburg Medical Center
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 |
More Information
No publications provided
| Responsible Party: | Mattejat, F., PhD, Institute of Behavioral-Therapy and -Medicine at the Philipps University MarburgDept. of Child and Adolescent Psychiatry, Philipps University Marburg |
| ClinicalTrials.gov Identifier: | NCT00564239 History of Changes |
| Other Study ID Numbers: | IVV-001-2007, IVV-001-2007 |
| Study First Received: | November 26, 2007 |
| Last Updated: | August 27, 2010 |
| Health Authority: | Germany: Ethics Commission |
Additional relevant MeSH terms:
|
Anxiety Disorders Depression Mental Disorders Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013