|- candidate number||8987|
|- NTR Number||NTR2707|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-jan-2011|
|- Secondary IDs||50-50110-96-639 ZonMw|
|- Public Title||Evaluation of a Smoking Cessation Intervention for Parents. |
|- Scientific Title||Evaluation of a Smoking Cessation Intervention for Parents. |
|- hypothesis||Telephone counseling is effective in aiding smoking cessation. The proportion of successful cessation after 3 months and 12 months will be significantly higher in the intervention condition compared to the control condition. Additionally, children of parents in the intervention condition will be more likely to have more negative attitudes and norms towards smoking, higher self-efficacy, and a lower intention to start smoking compared to children of parents in the control condition. |
|- Healt Condition(s) or Problem(s) studied||Smoking, Intergenerational transmission of smoking-related cognitions and behaviour|
|- Inclusion criteria||1. Parents of children in grades 6-8 (9-12 years);|
2. Daily or weekly smoking;
3. Current or future plans to quit smoking;
4. Informed consent.
|- Exclusion criteria||N/A|
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2011|
|- planned closingdate||1-sep-2012|
|- Target number of participants||512|
|- Interventions||In the intervention condition, a telephone counseling intervention will be delivered in collaboration with STIVORO (independent expert centre for tobacco control). The intervention consists of one intake call (20-30 minutes) and up to six additional telephone calls (10 minutes). All phone calls will be initiated by the counselor. Telephone counseling will take place during a period of three months and integrates motivational interviewing’s counseling style and cognitive-behavioral skill building components. Additionally, participants will receive three supplementary brochures providing further information about smoking and smoking cessation, motivation- and skill-enhancing messages, tips for quitting smoking, and cognitive-behavioural skill-building exercises.
In the control condition, participants will receive a standard brochure to aid smoking cessation.
|- Primary outcome||1. 7-day prevalent abstinence at 3 months;|
2. 7-day prevalent abstinence at 12 months;
3. continuous abstinence (abstinence between 3 and 12 months);
4. 24-h prevalent abstinence at 3 months;
5. 24-h prevalent abstinence at 12 months.
|- Secondary outcome||In smoking parents:|
1. Smoking characteristics (e.g., smoking intensity, smoking policies at home, motivation to quit, nicotine dependence);
2. Smoking cessation characteristics (e.g., occurrence of 24-h abstinence at some point, duration of quit attempts, number of quit attempts);
3. Smoking-related cognitions (e.g., pros and cons of smoking, self-efficacy, social norms).
In children of smoking parents:
4. Smoking-related cognitions (e.g., pros and cons of smoking, self-efficacy, social norms);
5. Smoking intentions and smoking behavior.
|- Timepoints||1. 0 (start);|
2. After 3 months;
3. After 12 months (end).
In the present study, we will primarily use validated measures (e.g., the FTND to assess nicotine dependence).
Additionally, we will use measures that are commonly employed in recent literature (e.g. self-reported abstinence rates to assess smoking cessation).
Incidentally, we will use measures that are novel or author-constructed.
|- Trial web site||www.rookvrij-opvoeden.nl|
|- CONTACT FOR PUBLIC QUERIES|| Kathrin Schuck|
|- CONTACT for SCIENTIFIC QUERIES|| Kathrin Schuck|
|- Sponsor/Initiator ||Radboud University Nijmegen|
(Source(s) of Monetary or Material Support)
|ZonMw programma Maatschappelijke Opvang|
|- Brief summary||The aim to study is to conduct a randomized, controlled trial to evaluate the effect of a telephone counseling intervention to aid smoking cessation in smoking parents. Parents will be proactively recruited through their childrens' elementary schools and randomized to the intervention condition or a control condition. In addition to the evaluation of the effectiveness of the intervention, we will test the preventive effects of parental smoking cessation on smoking-related cognitions (e.g., intention to smoke, self-efficacy, pros and cons of smoking, smoking norms) in their children. |
|- Main changes (audit trail)|
|- RECORD||21-jan-2011 - 29-mei-2011|