Condition category
Mental and Behavioural Disorders
Date applied
15/09/2010
Date assigned
07/10/2010
Last edited
04/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.z-proso.uzh.ch/

Contact information

Type

Scientific

Primary contact

Prof Manuel P Eisner

ORCID ID

Contact details

Institute of Criminology
University of Cambridge
Cambridge
CB3 9DT
United Kingdom
+44 (0)1223 33 53 74
mpe23@cam.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The Zurich Project on the Social Development of Children and Youth: A Combined Cluster-Randomised Controlled Trial to Evaluate the Short- and Long-Term Effectiveness of the PATHS School-Based Prevention Programme and of the Triple P Parent Training Programme

Acronym

z-proso

Study hypothesis

1. PATHS/PFADe
1.1. Children who were taught the adapted German version of the Promoting Alternative Thinking Strategies training (PATHS/PFADe) during regular school lessons will show an improved development regarding externalising problem behaviour, and social competence as compared to the control group.
1.2. Children who were taught PATHS/PFADe in high quality and intensity will show a better improvement than those who were taught PATHS/PFADe in medium or low quality/intensity

2. Standard Triple P parenting programme
2.1. Children whose parents were taught the Standard Triple P parenting programme will show an improved development regarding externalising problem behaviour as compared to the control group.
2.2. Parents who were taught the Standard Triple P parenting programme will show improved parenting skills as compared to the control group.

3. Combined condition
Children in the combined condition (PATHS & Triple P) will show the highest improvement compared to those in the "PATHS only" and in the "Triple P only" conditions.

Ethics approval

Minimally intrusive intervention, therefore ethical approval not required by the Swiss National Science Foundation nor by University of Zurich. Parental consent was obtained and all data stored according to data protection regulations.

Study design

Single location stratified cluster randomised trial with a 2x2 factorial design (embedded in a prospective longitudinal study)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

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

Condition

Externalising problem behaviour, delinquency, social skills, parenting skills

Intervention

1. German adaptation of the "Promoting Alternative Thinking Strategies" Programme (PATHS) called "Programm zur Förderung Alternativer Denkstrategien" (PFADe). PATHS/PFADe is a classroom-based curriculum aimed at improving social skills in children. The intervention was delivered during grade 2 (at age 8 to 9) typically in three weekly units of 20 minutes in all classes that were allocated to the corresponding treatment condition.
More information on the PATHS/PFADe is available at:
- http://www.pfade.ch/ and
- http://www.prevention.psu.edu/projects/PATHS.html

2. German, Portuguese, Turkish, English, and Albanian version of the "Standard Triple P" parent training. The intervention was made available to all parents in the corresponding treatment condition and consisted of 4 training units (approx. 2.5 hours) in classes of approx. 5 to 15 participants using audio-visual materials and followed by voluntary telephone counselling. The training was delivered at the end of grade 1.
More information on the programme is available at:
http://www.triplep.net/

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Social Behaviour Questionnaire (SBQ) developed by R. Tremblay et al.
The instrument was administered CAPI parent interviews, in paper-and-pencil teacher questionnaires as well as in an adapted audio-visual self-administered computer-aided child version. It aims at measuring various forms of aggression (physical, reactive, proactive, indirect) as well as ODD, non-aggressive externalising problem behaviour, ADHD, internalising problem behaviour, and prosociality.

Secondary outcome measures

1. PATHS assessed by Social Problem Solving vignettes developed by Dodge et al.
2. Triple P assessed by the Alabama Parenting Questionnaire (APQ) developed by Shelton et al. The instrument was administered in CAPI parent interviews. It aims at measuring five core dimensions of parenting behavious, i.e. positive parenting, parental commitment, monitoring, physical punishment, inconsistent discipline.

Overall trial start date

15/08/2004

Overall trial end date

31/10/2013

Reason abandoned

Eligibility

Participant inclusion criteria

All children who entered public primary school in the city of Zurich in summer 2004 (either sex) as well as their parents and teachers

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

1675

Participant exclusion criteria

All other children

Recruitment start date

15/08/2004

Recruitment end date

31/10/2013

Locations

Countries of recruitment

Switzerland

Trial participating centre

Institute of Criminology
Cambridge
CB3 9DT
United Kingdom

Sponsor information

Organisation

Swiss National Science Foundation (Switzerland)

Sponsor details

Wildhainweg 3
Postfach 8232
Bern
3001
Switzerland

Sponsor type

Research council

Website

http://www.snf.ch/

Funders

Funder type

Other

Funder name

Swiss National Science Foundation (Switzerland)

Alternative name(s)

Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Switzerland

Funder name

Jacobs Foundation (Switzerland)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Germany

Funder name

Swiss Federal Office of Public Health (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ministry of Education of the Canton of Zurich (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Swiss Federal Commission for Migration Issues (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Julius Baer Foundation (Switzerland)

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

1. 2007 Project Monograph
Early prevention of violence and aggression. Results of the Zurich prevention and intervention projects in schools (Frühprävention von Gewalt und Aggression. Ergebnisse des Zürcher Präventions- und Interventionsprojektes an Schulen). Eisner, M., Ribeaud, D., Jünger, R. & Meidert, U. (2007). Zürich: Rüegger Verlag. [in German]

A comprehensive listing of all project-related publications may be found at:
http://www.z-proso.uzh.ch/index.php?treenode_id=526

Publication citations

Additional files

Editorial Notes