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
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
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-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
Phase
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
01/08/2013
Overall trial end date
31/07/2018
Reason abandoned (if study stopped)
Eligibility
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
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
Funders
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
Location
Sweden
Funder name
VINNOVA
Alternative name(s)
Swedish Governmental Agency for Innovation Systems
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Sweden
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
Location
Sweden
Funder name
Vetenskapsrådet
Alternative name(s)
Swedish Research Council, VR, SRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Sweden
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: http://www.ncbi.nlm.nih.gov/pubmed/24131587
2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29926252
Publication citations
-
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.