Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
The tested intervention (level five intervention of Triple P, an intensive individual training for the family of children with behavioural problems) will cause a decrease in behavioural problems in children, dysfunctional parenting styles in parents, and depression, anxiety and stress in parents. Furthermore it will cause an increase in parenting competences in parents.
Ethics approval
Received from the local medical ethics committee
Study design
Multicentre, randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Behavioural and emotional problems in children
Intervention
The Triple P (Positive Parenting Program) consists of five levels, ranging from brief and broad support to parents in dealing with a child who exhibits behavioural problems to an intensive family intervention (level five). This intervention is aimed at family dysfunction and serious behavioural problems in a child. It offers intensive individual training for the family (around eleven sessions of one hour each, divided in modules), focusing on the childs behavioural problems (in combination with problems of the parents such as conflict between the partners, depression and stress).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Decrease of behavioural and emotional problems in children.
Secondary outcome measures
1. Decrease of dysfunctional parenting styles
2. Depression, anxiety and stress in parents
3. Increase of parenting competences
Overall trial start date
01/10/2006
Overall trial end date
31/12/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Multi-problem family
2. Children between four to 13 years old
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
200
Participant exclusion criteria
Does not comply with the above inclusion criteria
Recruitment start date
01/10/2006
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Trimbos Institute - Netherlands Institute of Mental Health and Addiction
Utrecht
3500 AS
Netherlands
Sponsor information
Organisation
Trimbos Institute - Netherlands Institute of Mental Health and Addiction (The Netherlands)
Sponsor details
P.O. Box 725
Utrecht
3500 AS
Netherlands
+31 (0)30 2971100
info@trimbos.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organization for Health Research and Development (ZonMw) (The Netherlands)
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