Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Many studies have shown that parenting support programs are effective in reducing behavioural and emotional problems in children. However, resources are limited and there is a debate about which program should be made available to parents. Triple P - Positive Parenting Program is an evidence-based program that is currently available in Sweden. Triple P level 2 is a low-cost program that consists of three large group seminars. Triple P level 3 and 4 are more intensive, with level 3 being delivered in one-to-one sessions and level 4 being delivered in small groups. In this study, we examine whether combining the three levels of Triple P is more effective than offering Triple P level 2 alone.

Who can participate?
All families with a child aged 3 to 5 in participating preschools in Uppsala, Sweden who can speak Swedish, Arabic, Somali, Persian, Sorani or English.

What does the study involve?
Participants will be asked to complete a set of questionnaires annually until the child is 5. Participating preschools will be randomly divided into three conditions: Universal, Universal Plus and Services as Usual. Families in the Universal and Universal Plus preschools will be invited to participate in a series of parenting seminars run by trained preschool teachers or community workers. These are Triple P seminars and provide practical advice on how to raise healthier and more competent children. Families in the Universal Plus preschools will receive additional parenting support by attending one-to-one or group sessions (Triple P primary Care or Group). These programs have a greater focus on parenting strategies that help to prevent behavioural problems. All three programs will be available throughout the project and parents can attend any time that is convenient for them.

What are the possible benefits and risks of participating?
Parents participating in one or more of the Triple P sessions may benefit from improved parenting skills, child behaviour and mental health. We do not expect any risks to be associated with participation.

Where is the study run from?
Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden

When is the study starting and how long is it expected to run for?
Recruitment is expected to start in August 2013 and end in July 2017

Who is funding the study?
Joint grant FORMAS (Sweden)

Who is the main contact?
Associate Professor Anna Sarkadi

Trial website

Contact information



Primary contact

Dr Anna Sarkadi


Contact details

Department of Women's and Children's Health
Uppsala University
SHS Vårdcentrum Box 609
751 25
+ 46 (0)18 611 59 65

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

The Children and Parents in Focus project: a population-based cluster randomised controlled trial to prevent behavioural and emotional problems in children


Study hypothesis

The aim of this population-based cluster randomised controlled trial is to prevent behavioural and emotional problems in pre-school children. The study has three arms:
1. Universal approach
2. Universal plus (universal and targeted) approach
3. Services-as-usual
The trialists hypothesise that compared to the services as usual, universal approach and the universal plus approach will have greater population reach and be more effective.

Ethics approval

Regional Ethics Committee in Uppsala, 14/11/2012, ref: 2012/437

Study design

Cluster randomised controlled trial

Primary study design


Secondary study design

Cluster randomised trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please contact Ms Anna Backman ( to request a patient information sheet.


Child behaviour and emotional problems


Universal arm: All families in this condition will be offered a light parenting program. The program includes 3 stand alone parenting seminars (Triple P level 2) and will be offered periodically throughout the implementation phase (August 2014 - July 2017). Parents are free to attend at any time.
Universal plus arm: All families in this condition will be offered the light parenting program described above as well as some extra support namely Triple P level 3 which consists of up to 4 brief individual sessions and Triple P level 4 which is an 8-session group program. All the three programs would be available throughout the implementation phase. Parents are free to attend at any time.
Services-as-usual arm: Families in this condition will only be offered the services as usual in their child health centre and preschool.

Intervention type



Not Applicable

Drug names

Primary outcome measure

Child externalising and internalising symptoms at ages 3, 4 and 5 measured by Strengths and Difficulties Questionnaires (SDQ)

Secondary outcome measures

1. Parenting practices
2. Parent mental health
3. Economic evaluation

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

All parents with a 3, 4, or 5-year-old child enrolled in the participating preschools in the municipality of Uppsala

Participant type


Age group




Target number of participants

Target sample size is 3000

Participant exclusion criteria

The study main language is Swedish. Study information and questionnaires are also available in the five most common languages in the immigrant community in Uppsala: Arabic, Somali, Persian, Sorani, and English. Parents will not be able to participate in the study if they neither understand Swedish nor any of the above languages.

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Uppsala University
751 25

Sponsor information


The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (Formas) (Sweden)

Sponsor details

Kungsbron 21
Box 1206
+46 (0)8-775 40 00

Sponsor type

Research council



Funder type

Research council

Funder name

Svenska Forskningsrådet Formas

Alternative name(s)

Swedish Research Council Formas, Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning

Funding Body Type

government organisation

Funding Body Subtype

National government



Funder name


Alternative name(s)

Swedish Governmental Agency for Innovation Systems

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government



Funder name

Forskningsrådet för Arbetsliv och Socialvetenskap

Alternative name(s)

Swedish Council for Working Life and Social Research, FAS

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit



Funder name


Alternative name(s)

Swedish Research Council, VR, SRC

Funding Body Type

government organisation

Funding Body Subtype

National government



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

Basic results (scientific)

Publication list

2013 protocol in:
2018 results in:

Publication citations

  1. Protocol

    Salari R, Fabian H, Prinz R, Lucas S, Feldman I, Fairchild A, Sarkadi A, The Children and Parents in Focus project: a population-based cluster-randomised controlled trial to prevent behavioural and emotional problems in children., BMC Public Health, 2013, 13, 961, doi: 10.1186/1471-2458-13-961.

Additional files

Editorial Notes

21/03/2019: Internal review. 25/06/2018: Publication reference added.