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
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