|- candidate number||3007|
|- NTR Number||NTR1182|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-jan-2008|
|- Secondary IDs||80-82405-98-02001 |
|- Public Title||Randomized Controlled Trial (RCT) of Parent Management Training Oregon Model (PMTO) for children with externalizing behavior problems in The Netherlands.|
|- Scientific Title||Randomized Controlled Trial (RCT) of Parent Management Training Oregon Model (PMTO) for children with externalizing behavior problems in The Netherlands.|
|- hypothesis||1. PMTO, compared to CAU, will result in statistically significant benefits in terms of: |
a. parenting skills;
b. parenting stress;
c. child behavior problems (externalizing and internalizing);
d. child prosocial behavior;
2. Benefits of PMTO will be observed at 6 months post baseline, and maintained in the ensuing follow-ups at 12 and 18 months;
3. PMTO program integrity, as measured by means of the FIMP rating system, will have a significant positive correlation with PMTO effectiveness;
4. PMTO, compared to CAU, will have higher treatment compliance and fewer dropouts.
|- Healt Condition(s) or Problem(s) studied||External behavior problems|
|- Inclusion criteria||1. Child Behavior Check List (CBCL) parent ratings of aggression, externalizing behavior and/or delinquency equal to or greater than 1.0 SD above the Dutch norm for the reference group; |
2. Child lives with at least one biological/adoptive parent.
|- Exclusion criteria||1. Parents with severe mental retardation/psychopathology (including substance abuse disorders); |
2. Sexual abuse in the family;
3. Children with mental retardation (IQ < 70).
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2008|
|- planned closingdate||1-jun-2012|
|- Target number of participants||228|
|- Interventions||1. PMTO (weekly sessions with a mean number of sessions of 25);|
2. Care As Usual (dependent on the institution).
|- Primary outcome||1. Child externalizing behaviour problems.|
|- Secondary outcome||1. Parental stress level;|
2. Psychological problems in parents;
3. Parenting skills;
4. Child internalizing behaviour problems;
5. Child prosocial behavior;
6. School performance of the children.
|- Timepoints||There are four assessment points: at intake (baseline, T0), at 6 months (T1), at 12 months (T2), and at 18 months (T3).|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. Corine Ruiter de|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Corine Ruiter de|
|- Sponsor/Initiator ||University Maastricht (UM)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, RVVZ, Stichting Kinderpostzegels Nederland, VSB Fonds|
|- Brief summary||Rationale: |
As longitudinal research has demonstrated a high degree of stability and aggravation of conduct problems in childhood into criminal and violent behavior in adulthood, early interventions can result in great benefit. There is currently a high need for effective treatment programs for children 4-10 years with antisocial conduct problems in The Netherlands. The Ministry of Health decided in 2005 to fund the implementation of Parent Management Training Oregon model (PMTO), a theory-driven, evidence-based intervention for parents of children with externalizing behavior problems.
The proposed RCT has as its goal to test the effectiveness of PMTO against Care As Usual (CAU).
The study will be conducted as Randomized Controlled Trial (RCT) with assessments at regular intervals, i.e. baseline (pretreatment), 6, 12 and 18 months. Four youth (mental health) care institutions in The Netherlands are committed to participate in the current project, and have guaranteed sufficient patient supply.
Study population: Parents with children in the age range of 4-10 years old with externalizing behaviour problems who are referred to the four participating youth care institutions by different sources, such as family physicians, paediatricians and Bureaus Jeugdzorg.
One group receives PMTO once a week, the other group receives CAU.
Main study parameters/endpoints:
The main study parameter is the change of behaviour problems of the children from baseline to endpoint.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Parents and children will participate in assessments at fixed time intervals. This will require some time and effort on their part. There are no risks involved; possible benefits are: increased parenting competence, decrease in child behaviour problems, overall stress reduction within the family.
|- Main changes (audit trail)|
|- RECORD||15-jan-2008 - 17-apr-2008|