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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01352104
Other study ID # DO 620/2-4
Secondary ID
Status Completed
Phase N/A
First received May 9, 2011
Last updated May 10, 2011
Start date January 2004
Est. completion date December 2006

Study information

Verified date April 2011
Source German Research Foundation
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Committee at the University of Cologne
Study type Interventional

Clinical Trial Summary

Investigating effectiveness of the cognitive-behavioral based teacher training under routine care conditions by comparison of a baseline-interval with no special intervention to a following interval of PEP for the kindergarten teachers only each focussing on one child (3-6 years old) that the teacher herself indicated as "needing special attention for externalising behaviour". Effects on child symptoms and teachers behavior and burden within intervention-period are expected to be stronger than those during waiting-period.


Description:

Findings of the PEP-efficacy-study based on a randomised controlled sampling ((ISRCTN CCT-NAPN-18918) using combined training-modules for parents and teachers showed positive effects on children's behaviour in the intervention-group. These effects in teacher's view were stronger than in the control-group but could not be proved to be statistically significant. Moreover after this first step of evaluation there remain unanswered questions concerning the stability of effects after transferring the program in routine care. Therefore the study is continued by an effectiveness-study.


Recruitment information / eligibility

Status Completed
Enrollment 144
Est. completion date December 2006
Est. primary completion date March 2005
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 6 Years
Eligibility Inclusion Criteria:

- teacher's interest in participating in a specific further training

- Identification of a target child (externalizing problem behavior)by teacher

- possibility of participation in at least 4 assessments (pre1, pre2, post,1stFU)

Exclusion Criteria:

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms

  • Behavior Problem of Childhood and Adolescence

Intervention

Behavioral:
PEP-TE
PEP-TE for kindergarten teachers of children with externalizing behaviour problems aged 3 to 6 years leads to use classical strategies of changing behaviour (defining rules, appropriate commands, positive and negative consequences) based on the "coercive interaction process" (cf. Patterson, 1982) as explanatory model for target situations. In 10 units (90-120 minutes) four to six teachers in one group develop individually tailored solutions to specified externalizing behavior problems of the target child. General strategies of improving positive interactions as well as resources and strategies for reducing stress and gaining new energy are discussed. Summary and reflection of the teacher' experiences and ideas of changes in routines prevents relapses.

Locations

Country Name City State
Germany Clinic for Child and Adolescent Psychiatry and Psychotherapy, University of Cologne Cologne NRW

Sponsors (1)

Lead Sponsor Collaborator
German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in children's externalizing behavior Externalizing Behavior Scale of the Caregiver/Teacher-Report Form (C-TRF/ 1 1/2-, Achenbach, T.M. & Rescorla L.A.,2001) rated by participating teacher pre1, pre2, post, 3-, 6-, 9- & 12 month FU No
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