Condition category
Mental and Behavioural Disorders
Date applied
22/11/2006
Date assigned
22/11/2006
Last edited
14/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.trimbos.nl

Contact information

Type

Scientific

Primary contact

Dr I de Graaf

ORCID ID

Contact details

Trimbos Institute - Netherlands Institute of Mental Health and Addiction
P.O. Box 725
Utrecht
3500 AS
Netherlands

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 child’s 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

Publication citations

Additional files

Editorial Notes