|- candidate number||4153|
|- NTR Number||NTR1465|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-sep-2008|
|- Secondary IDs||50-50110-96-511 / 2007 3.4.07.041 ZonMW / AF|
|- Public Title||Test of a Smoking Prevention Program for Parents of Primary School Children.|
|- Scientific Title||Test of a Smoking Prevention Program for Parents of Primary School Children.|
|- ACRONYM||Smoke-free Kids|
|- hypothesis||Two hypotheses will be tested. First, we expect that parents involved in the program (as compared to controls) will be more involved in constructive communication on smoking topics, have more confidence in discussing smoking matters and greater efficacy to prevent their children from smoking, set and keep stricter household rules against smoking, establish a non-smoking contract with their children, and are more likely to monitor children’s and peers’ smoking-related activities.
We will test whether the effects of the intervention program are different for children with asthma.
Second, we expect that children of smoking parents involved in this program will be less likely to engage in smoking. Based on the findings of a successful RCT carried out in the US, we expect that relative to controls, children in the intervention condition will be less likely to experiment with smoking at follow-up measurements.
|- Healt Condition(s) or Problem(s) studied||Asthma, Smoking, Smoking, Prevention, Children|
|- Inclusion criteria||1. Participating adults need to be the mother or a female guardian;|
2. Having a child aged between 9-11 years-old and has never tried smoking;
3. Mother and child need to be able to speak and read Dutch;
4. Only one child per household is eligible to participate;
5. Because of special interest in smoking and asthma, a significant number of children will be included who experience asthma symptoms.
|- Exclusion criteria||1. Fathers or male guardian;|
2. Children outside the range of 9-11 years-old;
3. Not being able to speak and read Dutch;
4. More than 1 child per household participating in the study.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||13-okt-2008|
|- planned closingdate||31-dec-2012|
|- Target number of participants||856|
|- Interventions||The objective of the present study is to test an intervention program focusing on anti-smoking socialization skills for parents of primary school children: ‘Smoke-free Kids’.|
Smoke-free Kids is a home-based program and consists of a series of six activity guides for parents and children to complete together. These guides will be mailed to their homes every month. The intervention also includes tip sheets focusing on parenting skills and a series of newsletters for children.
For the control group an alternative program will be used based on facts. These factsheets provide knowledge about youth smoking and focuses parents attention on macro level variable relevant to youth smoking by not targeted by treatment versions of the program.
|- Primary outcome||Initiation of cigarette smoking. The response options for these questions include indicators of having never puffed on a cigarette. |
The intervention will start in February 2009. The mothers will receive every month an activity guide. Mothers and Children are structured-interviewed by telephone.
|- Secondary outcome||* Child susceptibility to cigarette smoking|
* Child cognitions:
- Intention to smoke
- Social norm
* Parent-child relationship
* General parenting style
* Parent smoking behavior
* Anti-smoking socialization
- Communication about smoking
- Parental warnings
- Availability of cigarettes at home
- Parental norms
- Parental influence on their offspring smoking
- House rules
- Possible reactions of parents
* Environmental influences (e.g. parents and friends)
* Child well-being
- Self esteem
* Asthmatic symptoms
|- Timepoints||Baseline, 6, 12, 24, 36 months|
|- Trial web site||http://www.rookvrijekids.nl|
|- CONTACT FOR PUBLIC QUERIES||MSc. Marieke Hiemstra|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. R.C.M.E. Engels|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen, University Maastricht (UM), STIVORO, Trimbos-institute - Netherlands Institute of Mental Health and Addiction|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Netherlands Asthma Foundation|
|- Brief summary||The aim of the project is to test a highly innovative and successfully tested program in the U.S. for mothers and children of primary school age in a Dutch sample. A randomized controlled trial (RCT) will be conducted among mothers of 9-11 year-olds, both with and without asthma, and short- and long-term assessments on child smoking indicators and anti-smoking socialization will be conducted. |
|- Main changes (audit trail)|
|- RECORD||30-sep-2008 - 4-dec-2009|