|- candidate number||8344|
|- NTR Number||NTR2474|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-aug-2010|
|- Secondary IDs||50-51300-98-007 ZonMW|
|- Public Title||Pilot Study of an Alcohol Prevention Program for Parents of Primary School Children.|
|- Scientific Title||Pilot Study of an Alcohol Prevention Program for Parents of Primary School Children.|
|- ACRONYM||In Control: No Alcohol!|
|- hypothesis||We expect that parents involved in the program (as compared to controls) will be more involved in high qualitative communication on alcohol topics, have more confidence in discussing alcohol matters and greater efficacy to prevent their children from drinking alcohol, set and keep stricter household rules against alcohol, establish a non-drinking contract with their children, and are more likely to monitor children's and peers' alcohol-related activities. |
|- Healt Condition(s) or Problem(s) studied||Prevention, Children, Alcohol, Parents|
|- Inclusion criteria||1. Participating mothers need to be the mother or a female guardian;|
2. Having a child in the 8th grade of the Dutch elementary school system;
3. Mother and child need to be able to speak and read Dutch;
4. Only one child per household is eligible to participate.
|- Exclusion criteria||1. Fathers or male guardians;|
2. Children outside grade 8 of the Dutch elementary school system;
3. Mother or child not being able to speak and read Dutch;
4. More than 1 child per household participating in the study.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2009|
|- planned closingdate||31-dec-2010|
|- Target number of participants||200|
|- Interventions||The objective of the present study is to test an intervention program focusing on anti-alcohol socialization skills for parents of primary school children: 'In control: No alcohol!'. In control: No alcohol! is a home-based program and consists of a series of five activity guides for parents and children to complete together. These guides will be mailed to their homes every month.
For the control group an alternative brochure will be used based on facts. This brochure provides knowledge about youth drinking.
|- Primary outcome||Anti-alcohol socialization:|
1. Frequency and quality of communication about alcohol;
3. Parental norms;
4. House rules.
The intervention will start in November 2009. The mothers will receive an activity guide every month. Mothers and children fill in online-questionnaires.
|- Secondary outcome||1. Child cognitions:|
A. Intention to drink alcohol;
B. Attitude towards drinking;
C. Alcohol expectations.
2. Child alcohol use;
3. Friend alcohol use;
4. Parental support;
4. Parental alcohol use;
5. Parental alcohol-related problems;
6. Anti-alcohol socialization:
A. Availability of alcohol at home;
B. Psychological control.
|- Timepoints||Baseline, 6 and 12 months.|
|- Trial web site||http://www.houvolgeenalcohol.nl/|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MSc. Suzanne Mares|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Rutger C.M.E. Engels|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen, 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|
|- Brief summary||The aim of the project is to test a highly innovative program for mothers and children of primary school age in a Dutch sample. A randomized controlled trial (RCT) will be conducted among mothers of 8th grade children, and short-term assessments on anti-alcohol socialization will be conducted.|
|- Main changes (audit trail)|
|- RECORD||18-aug-2010 - 16-sep-2010|