NCT00564239

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

April 30, 2018

Status Verified

April 1, 2018

Enrollment Period

1.5 years

First QC Date

November 26, 2007

Last Update Submit

April 26, 2018

Conditions

Anxiety SymptomsDepressive SymptomsSomatoform Symptoms

Outcome Measures

Primary Outcomes (1)

  • Child Behavior Checklist (german version)

    3, 6, 18 months

Secondary Outcomes (6)

  • Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK)- Assessment of life quality, parent and child versions

    3, 6, 18 months

  • Spence Children's Anxiety Scale (SCAS)

    3, 6, 18 months

  • Depressionsinventar für Kinder- und Jugendliche (DIKJ), german depression inventory based on CDI

    3, 6, 18 months

  • Giessener Beschwerdebogen für Kinder- und Jugendliche (GBB-KJ), report of somatic symptoms, parent and child versions

    3, 6, 18 months

  • Culture Fair Intelligence Test (CFT 20-R)

    initially

  • +1 more secondary outcomes

Study Arms (3)

A

EXPERIMENTAL
Behavioral: Cognitive Behavioral Group Therapy

B

ACTIVE COMPARATOR
Behavioral: Cognitive Behavioral Group Therapy

C

NO INTERVENTION

Interventions

Cognitive Behavioral Group TherapyBEHAVIORAL

12 children group sessions, 8 parent group sessions

A

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut für Verhaltenstherapie und -medizin (IVV)

Marburg, Hesse, D-35039, Germany

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Jan Pauschardt, Dr.

    Philipps University Marburg

    PRINCIPAL INVESTIGATOR

  • Sylvia D Eimecke, Dr.

    Philipps University Marburg

    PRINCIPAL INVESTIGATOR

  • Fritz Mattejat, PhD

    Philipps University Marburg

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. rer. nat.

Study Record Dates

First Submitted

November 26, 2007

First Posted

November 27, 2007

Study Start

November 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

April 30, 2018

Record last verified: 2018-04

Locations

DE(1)