The Children and Parents in Focus project

ISRCTN	ISRCTN16513449
DOI	https://doi.org/10.1186/ISRCTN16513449
Secondary identifying numbers	N/A

Submission date: 20/06/2013
Registration date: 23/07/2013
Last edited: 21/03/2019

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

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

Contact information

Dr Anna Sarkadi
Scientific

Department of Women's and Children's Health
Uppsala University
SHS Vårdcentrum Box 609
Uppsala
751 25
Sweden

Phone	+ 46 (0)18 611 59 65
Email	anna.sarkadi@kbh.uu.se

Study information

Study design	Cluster randomised controlled trial
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	Other
Study type	Prevention
Participant information sheet	Not available in web format, please contact Ms Anna Backman (anna.backman@kbh.uu.se) to request a patient information sheet.
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 objectives	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(s)	Regional Ethics Committee in Uppsala, 14/11/2012, ref: 2012/437
Health condition(s) or problem(s) studied	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-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	Other
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 study start date	01/08/2013
Completion date	31/07/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Target sample size is 3000
Key inclusion criteria	All parents with a 3, 4, or 5-year-old child enrolled in the participating preschools in the municipality of Uppsala
Key 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.
Date of first enrolment	01/08/2013
Date of final enrolment	31/07/2017

Locations

Countries of recruitment

Sweden

Study participating centre

Uppsala University

Uppsala
751 25
Sweden

Sponsor information

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

Kungsbron 21
Box 1206
Stockholm
11182
Sweden

Phone	+46 (0)8-775 40 00
Email	registrator@formas.se
Website	http://www.formas.se
"ROR"	https://ror.org/03pjs1y45

Funders

Funder type

Research council

Svenska Forskningsrådet Formas
Government organisation / National government

Alternative name(s): Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning, Swedish Research Council Formas, Formas
Location: Sweden

VINNOVA
Government organisation / National government

Alternative name(s): Swedish Governmental Agency for Innovation Systems
Location: Sweden

Forskningsrådet för Arbetsliv och Socialvetenskap
Private sector organisation / Other non-profit organizations

Alternative name(s): Swedish Council for Working Life and Social Research, FAS
Location: Sweden

Vetenskapsrådet
Government organisation / National government

Alternative name(s): Swedish Research Council, VR
Location: Sweden

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?
Protocol article	protocol	16/10/2013		Yes	No
Results article	results	01/01/2019		Yes	No

Editorial Notes

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