Condition category
Mental and Behavioural Disorders
Date applied
20/06/2013
Date assigned
23/07/2013
Last edited
19/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
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
anna.sarkadi@kbh.uu.se

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anna Sarkadi

ORCID ID

Contact details

Department of Women's and Children's Health
Uppsala University
SHS Vårdcentrum Box 609
Uppsala
751 25
Sweden
+ 46 (0) 18-611 59 65
anna.sarkadi@kbh.uu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

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

Acronym

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.
We 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

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please contact Ms Anna Backman (anna.backman@kbh.uu.se) to request a patient information sheet.

Condition

Child behaviour and emotional problems

Intervention

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-seesion 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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

01/08/2013

Overall trial end date

31/07/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Eligible participants are all parents with a 3, 4, or 5-year-old child enrolled in the participating preschools in the municipality of Uppsala.

Participant type

Patient

Age group

Adult

Gender

Both

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

01/08/2013

Recruitment end date

31/07/2017

Locations

Countries of recruitment

Sweden

Trial participating centre

Uppsala University
Uppsala
751 25
Sweden

Sponsor information

Organisation

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

Sponsor details

Kungsbron 21
Box 1206
Stockholm
11182
Sweden
+46 (0)8-775 40 00
registrator@formas.se

Sponsor type

Research council

Website

http://www.formas.se

Funders

Funder type

Research council

Funder name

The trial is funded by a joint grant from FORMAS (The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning) (Sweden), Vetenskapsrådet (Swedish Research Council) (Sweden), FAS (Swedish Council for Working Life and Social Research) (Sweden), and VINNOVA (Swedish Governmental Agency for Innovation Systems) (Sweden).

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

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24131587

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