|- candidate number||14245|
|- NTR Number||NTR3810|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-jan-2013|
|- Secondary IDs||50-51510-98-112 ZonMw|
|- Public Title||Effectiveness of Zippy's Friends: A randomized controlled trial of a school-based program to promote social-emotional skills in young children.|
|- Scientific Title||Effectiveness of Zippy's Friends: A randomized controlled trial of a school-based program to promote social-emotional skills in young children.|
|- hypothesis||Zippy's Friends is more effective in promoting social-emotional skills and decreasing problem behavior than the 'education as usual' control group.|
|- Healt Condition(s) or Problem(s) studied||Social-emotional skills|
|- Inclusion criteria||1. Schools with a relatively high percentage of children from low SES families are recruited throughout the Netherlands;|
2. Participating children are aged 6 to 8 (primary school, group 3 and 4);
3. Aim is that at least one third (33%) of the recruited schools have a significant immigrant population to enable meaningful analyses between immigrant groups, which is operationalized as that 8 of the 24 classes per condition has 20% or more immigrant students, and half of these classes per condition has 40% or more immigrant students in their classes;
4. Passive informed consent from parents.
|- Exclusion criteria||Participants not meeting the aforementioned criteria.|
|- mec approval received||no|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2011|
|- planned closingdate||1-mei-2015|
|- Target number of participants||1108|
|- Interventions||The aim of the ZF program is to improve the children’s social and emotional skills. The ultimate goal is to strengthen their mental resilience and to diminish their risks of developing emotional and/or behavioral problems. The underlying objective throughout ZF is to expand the children’s repertoire of social and emotional skills and their abilities to adapt these into different situations. The full ZF program consists of 24 classroom lessons, training and support to teachers from experienced trainers, teaching materials for teachers and the children and information materials for parents. The ZF class room program is based around a set of 6 illustrated stories about a group of children, their families, friends and a stick insect Zippy [in Dutch: 'wandelende tak']. The stories describe issues which young children typically experience: Feeling lonely, angry, jealous, friendship difficulties, bullying, dealing with change and loss. The sessions are divided into six modules: feelings, communication, making and breaking relationships, conflict resolution, dealing with change and loss, general coping skills.
The control group will receive education as usual.
|- Primary outcome||Social-emotional skills. Questionnaires completed by the children, teachers and parents will be used to measure the primary outcome.|
|- Secondary outcome||1. Behavior problems (internalizing and externalizing) - (teacher and parent reports);|
2. Class Climate - (teacher- and child reports).
Questionnaires will be used to measure the abovementioned secondary outcomes.
|- Timepoints||1. Baseline (T0, September-November 2012);|
2. Post-intervention (T1, May-July 2013);
3. Follow-up: 18 months after baseline (T2, May-July 2014).
|- Trial web site||www.zippysvrienden.nl |
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| R. Zanden, van der|
|- CONTACT for SCIENTIFIC QUERIES||MSc. Debbie Linden, van der|
|- Sponsor/Initiator ||Trimbos-institute - Netherlands Institute of Mental Health and Addiction|
(Source(s) of Monetary or Material Support)
|Stichting Achmea Gezondheidszorg (SAG), ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||The aim of our study is to determine the effectiveness of the universal school-based ZF program in terms of increased social and emotional skills en decreased problem behavior for children aged 6-8 in the Netherlands in primary schools with a relatively high percentage of children from families with a low socio-economic status. We are conducting a cluster RCT of the school-based ZF program with an experimental condition and an 'education as usual' control condition. ZF will be taught in the experimental condition. Randomization is stratified by school, accounting for level of immigrants and level of urbanization.|
|- Main changes (audit trail)|
|- RECORD||22-jan-2013 - 4-feb-2013|