Behavior Problem of Childhood and AdolescencePEP-TENCT01352104
Effectiveness of the Teacher Module of the Prevention Program for Externalizing Problem Behaviour in Preschoolers
A study testing PEP-TE in people with Behavior Problem of Childhood and Adolescence, run by German Research Foundation at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Behavior Problem of Childhood and Adolescence
- What is being tested?
- PEP-TE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2004to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic for Child and Adolescent Psychiatry and Psychotherapy, University of Cologne
Cologne, North Rhine-Westphalia, 50931
About this study
Official title: Effectiveness of Guiding Teachers in Individualized Behavioral Intervention Strategies With Preschool Children Indicated for Externalizing Problem Behavior
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.
Read the 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.
- Being tested
- PEP-TE
- Keywords
- Externalizing Problem Behaviour in Preschoolers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP-TEBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| waiting-intervention-course | Experimental | Not described Receives: Behavioral: PEP-TE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: pre1, pre2, post, 3-, 6-, 9- & 12 month FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startJan 2004
- Primary completionMar 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior Problem of Childhood and AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Research Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Manfred Döpfner, PhD, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352104
- Sponsor's protocol ID
- DO 620/2-4
- Acronym
- PEP-TE
- Status last verified
- Apr 2011
- First submitted
- 9 May 2011
- Last updated
- 11 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Guiding Teachers in Individualized Behavioral Intervention Strategies With Preschool Children Indicated for Externalizing Problem Behavior
- ClinicalTrials.gov ID
- NCT01352104
- Acronym / sponsor ID
- PEP-TE / DO 620/2-4
- Keywords
- Externalizing Problem Behaviour in Preschoolers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- German Research FoundationUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Mar 2005 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 11 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| waiting-intervention-course | Experimental | Behavioral: PEP-TE |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEP-TEPEP-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. | Behavioural | waiting-intervention-course |
Primary outcome
Change in children's externalizing behavior
Time frame: pre1, pre2, post, 3-, 6-, 9- & 12 month FU
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manfred Döpfner, PhD principal investigator
University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEP-TE in people with Behavior Problem of Childhood and Adolescence, run by German Research Foundation at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in children's externalizing behavior (time frame: pre1, pre2, post, 3-, 6-, 9- & 12 month FU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2011.