Condition category
Mental and Behavioural Disorders
Date applied
21/07/2009
Date assigned
26/01/2010
Last edited
26/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Manfred Doepfner

ORCID ID

Contact details

Robert Koch Str. 10
Cologne
50931
Germany
+49 (0)221 4786105
Manfred.Doepfner@t-online.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Efficacy or indicated prevention in children with deviant externalising behaviour aged 3 to 6: a cluster-randomised indicated prevention trial

Acronym

PEP

Study hypothesis

1. Reduction of externalising symptoms assessed by parents and kindergarten teachers
2. Improvement of parents' and teachers' educational behaviour
3. Reduction of parental stress
4. Long-term stability of these effects

Ethics approval

Ethics Committee of the German Research Foundation approved on the 7th November 2000

Study design

Cluster-randomised indicated prevention trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Externalising behaviour (symptoms of attention deficit hyperactivity disorder [ADHD], oppositional defiant disorder [ODD], aggression)

Intervention

PEP consists of 10 sessions (90 to 120 minutes each) and a constituting session. Minimum time between two sessions was 1 week. Therefore after the pre-test period (4 months, including home visits at each family) the training period took 3 to 4 months depending on holidays and external reasons for each groups' schedule. Appointments for post test in both arms were planned just after the last session of PEP within the intervention group. Follow ups were carried out via questionnaires only and via mail 1 year after pre-test. Therefore the interval between the timepoints was about six months for each family. The trial was carried out in 2 waves.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

ADHD and ODD Symptom Checklist (Diagnostic and Statistical Manual of Mental Disorders, fourth edition [DSM IV]) rated by parents and teachers, measured at pre- and post-test.

Secondary outcome measures

Dimensions of educational behaviour, burden and stress, measured at pre- and post-test.

Overall trial start date

15/07/2001

Overall trial end date

14/09/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children enrolled in public kindergarten
2. Aged 3 to 6 years, either sex
3. At risk for developing externalising behaviour problems
4. Increased scores in a screening questionnaire rated by parents and teachers

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2500 for screening, 150 indicated individuals for randomisation

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

15/07/2001

Recruitment end date

14/09/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Robert Koch Str. 10
Cologne
50931
Germany

Sponsor information

Organisation

University Hospital of Cologne (Uniklinik Köln) (Germany)

Sponsor details

c/o Prof Dr Manfred Doepfner
Klinik und Poliklinik für Psychiatrie und Psychotherapie des Kindes- und Jugendalters
Robert-Koch-Str. 10
Köln
D-50931
Germany
+49 (0)221 478 6105
manfred.doepfner@uk-koeln.de

Sponsor type

Hospital/treatment centre

Website

http://www.medizin.uni-koeln.de/index.e.shtml

Funders

Funder type

Research council

Funder name

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes