Prevention program for Externalising Problem behaviour

ISRCTN	ISRCTN12686222
DOI	https://doi.org/10.1186/ISRCTN12686222
Secondary identifying numbers	N/A

Submission date: 21/07/2009
Registration date: 26/01/2010
Last edited: 29/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Manfred Doepfner
Scientific

Robert Koch Str. 10
Cologne
50931
Germany

Phone	+49 (0)221 4786105
Email	Manfred.Doepfner@t-online.de

Study information

Study design	Cluster-randomised indicated prevention trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Efficacy or indicated prevention in children with deviant externalising behaviour aged 3 to 6: a cluster-randomised indicated prevention trial
Study acronym	PEP
Study objectives	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(s)	Ethics Committee of the German Research Foundation approved on the 7th November 2000
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	15/07/2001
Completion date	14/09/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	2500 for screening, 150 indicated individuals for randomisation
Total final enrolment	155
Key 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
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	15/07/2001
Date of final enrolment	14/09/2009

Locations

Countries of recruitment

Germany

Study participating centre

Robert Koch Str. 10

Cologne
50931
Germany

Sponsor information

University Hospital of Cologne (Uniklinik Köln) (Germany)
Hospital/treatment centre

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

Phone	+49 (0)221 478 6105
Email	manfred.doepfner@uk-koeln.de
Website	http://www.medizin.uni-koeln.de/index.e.shtml
"ROR"	https://ror.org/05mxhda18

Funders

Funder type

Research council

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other publications	participation rate analysis	28/05/2010	29/12/2020	Yes	No
Results article	results	23/12/2013	29/12/2020	Yes	No

Editorial Notes

29/12/2020: The following changes have been made:
1. Publication references added.
2. The final enrolment number has been added from the reference.