Psychological Prevention of Internalizing Disorders

• Sponsor: Philipps University Marburg Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00564239
• Collaborator: Institute of Behavioral-Therapy and -Medicine at the Philipps University Marburg (Other), Dept. of Child and Adolescent Psychiatry, Philipps University Marburg (Other)
• Enrollment: 77
• Location: 1
• Arms: 3
• Duration (Months): 18
• Patients Per Site Per Month: 4.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Symptoms; Depressive Symptoms; Somatoform Symptoms	Behavioral: Cognitive Behavioral Group Therapy; Behavioral: Cognitive Behavioral Group Therapy	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 77 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Efficacy of Child-centered Cognitive-Behavioral Prevention of Internalizing Disorders and the Impact of Simultaneous Parent Training
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Child Behavior Checklist (german version) [3, 6, 18 months]

Secondary Outcome Measures

1. Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK)- Assessment of life quality, parent and child versions [3, 6, 18 months]

2. Spence Children's Anxiety Scale (SCAS) [3, 6, 18 months]

3. Depressionsinventar für Kinder- und Jugendliche (DIKJ), german depression inventory based on CDI [3, 6, 18 months]

4. Giessener Beschwerdebogen für Kinder- und Jugendliche (GBB-KJ), report of somatic symptoms, parent and child versions [3, 6, 18 months]

5. Culture Fair Intelligence Test (CFT 20-R) [initially]

6. Symptom-Checklist (SCL-90-R), german version [3, 6, 18 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Institut für Verhaltenstherapie und -medizin (IVV)	Marburg	Hessen	Germany	D-35039

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jan Pauschardt, Dr. rer. nat., Philipps University Marburg Medical Center
• ClinicalTrials.gov Identifier: NCT00564239
• Other Study ID Numbers: IVV-001-2007; IVV-001-2007
• First Posted: Nov 27, 2007
• Last Update Posted: Apr 30, 2018
• Last Verified: Apr 1, 2018

• Additional relevant MeSH terms: Depression

Study Results

No Results Posted as of Apr 30, 2018