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Effectiveness of the Teacher Module of the Prevention Program for Externalizing Problem Behaviour in Preschoolers (PEP-TE)

Primary Purpose

Behavior Problem of Childhood and Adolescence

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
PEP-TE
Sponsored by
German Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Behavior Problem of Childhood and Adolescence focused on measuring Externalizing Problem Behaviour in Preschoolers

Eligibility Criteria

3 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

  • Clinic for Child and Adolescent Psychiatry and Psychotherapy, University of Cologne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

waiting-intervention-course

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 9, 2011
Last Updated
May 10, 2011
Sponsor
German Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01352104
Brief Title
Effectiveness of the Teacher Module of the Prevention Program for Externalizing Problem Behaviour in Preschoolers
Acronym
PEP-TE
Official Title
Effectiveness of Guiding Teachers in Individualized Behavioral Intervention Strategies With Preschool Children Indicated for Externalizing Problem Behavior
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
German Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior Problem of Childhood and Adolescence
Keywords
Externalizing Problem Behaviour in Preschoolers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
waiting-intervention-course
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
PEP-TE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in children's externalizing behavior
Description
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
Time Frame
pre1, pre2, post, 3-, 6-, 9- & 12 month FU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manfred Döpfner, PhD
Organizational Affiliation
University of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic for Child and Adolescent Psychiatry and Psychotherapy, University of Cologne
City
Cologne
State/Province
NRW
ZIP/Postal Code
50931
Country
Germany

12. IPD Sharing Statement

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Effectiveness of the Teacher Module of the Prevention Program for Externalizing Problem Behaviour in Preschoolers

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