|- candidate number||25313|
|- NTR Number||NTR6092|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-sep-2016|
|- Secondary IDs||2015-7944 |
|- Public Title||De implementatie van een effectieve interventie om te stoppen met roken voor ouders.|
|- Scientific Title||Recruitment strategies for an effective smoking cessation program for parents|
|- hypothesis||It is important that parents quit smoking, as this has serious detrimental effects on their own health and their children's health. The majority of parents want to quit smoking. However, many quit attemts are unsuccessful. Recently a proactive telephone counseling intervention for smoking parents was examined and found to be highly effective in the Netherlands. Therefore, it is time that this intervention will be implemented on a large scale.|
The purpose of this study is to set up an implementation randomized controlled trial to:
1. obtain information about the recruitment success of three different recruitment strategies (i.e., primary schools, maternity centers, and medical professionals) and to conduct a process evaluation for each of the three recruitment strategies;
2. test the effectiveness of the intervention and the extent to which the three different recruitment strategies have a differential effect on the main outcome, and to apply a Net-Benefit Regression Framework for analyzing cost-effectivess of this intervention;
3. to develop an implementation plan based on the information obtained from the various analyses and process evaluation.
|- Healt Condition(s) or Problem(s) studied||Smoking, Parents|
|- Inclusion criteria||1) being at least a weekly smoker;|
2) being a parent/caretaker of a child between 0 and 12 years old;
3) having the intention to quit smoing (currently or in the future);
4) giving informed consent for participation.
|- Exclusion criteria||N.A. |
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-sep-2016|
|- planned closingdate||31-aug-2018|
|- Target number of participants||360|
|- Interventions||In the telephone counseling condition parents receive proactive telephone counseling based on MI and cognitive-behavioural skill building. Each parent receives up to six counselor-initiated phone calls (approximately 20 minutes) across a period of three months. In addition, they receive a supplementary brochure on smoking cessation, which is designed for this study as tailored supplementary material.
In the control condition parents receive within two weeks after baseline assessment a standard brochure on smoking cessation. This brochure is a 16-page colour-printed booklet.
|- Primary outcome||The primary outcome measures is 7-day point prevalence abstinence at twelve months post-intervention.|
|- Secondary outcome||Secondary outcome measures include: |
1) 7-day point prevalence abstinence at 3-months; 2) prolonged abstinence (defined as report of cessation for a period of at least six months at 12-months);
3) occurrence of at least 24 hours abstinence at some point during the study;
4) 4-week quitter (defined as "has not smoked even a single puff on a cigarette in the past 2 weeks" assessed 4 weeks after the designated quit date);
5) 52-week quitter (defined as "has not smoked more than 5 cigarrettes in the past 50 weeks" assessed 52 weeks after the designated quit date);
6) increase in motivation to quit;
7) number and duration of quit attempts;
8) use of and adherence to nicotine replacement therapy;
9) implementation of smoking restrictions at home;
10) change in smoking-related cognitions (e.g., social norms, attitudes towards smoking, and self-efficacy).
|- Timepoints||All outcome measures will be assessed in online questionnaires.
The primary outcome measures will be assessed at twelve months post-intervention.
Secondary outcome measures:
1) 7-day point prevalence abstinence at 3-months will be assessed at three months post-intervention;
2) prolonged abstinence will be assessed at twelve months post-intervention;
3) occurrence of at least 24 hours abstinence at some point during the study will be assessed at both three months post-intervention and twelve months post-intervention;
4) 4-week quitter will be assessed at three months-post intervention;
5) 52-week quitter will be assessed at twelve months post-intervention;
6) increase in motivation to quit will be assessed at baseline, three months post-intervention, and twelve months post-intervention;
7) number and duration of quit attempts will be assessed at baseline, three months post-intervention, and twelve months post-intervention;
8) use of and adherence to nicotine replacement therapy will be assessed at three months post-intervention, and twelve months post-intervention;
9) implementation of smoking restrictions at home will be assessed at baseline, three months post-intervention, and twelve months post-intervention;
10) change in smoking-related cognitions will be assessed at baseline, three months post-intervention, and twelve months post-intervention.
|- Trial web site||www.rookvrijeouders.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Tessa Scheffers-van Schayck|
|- CONTACT for SCIENTIFIC QUERIES|| Tessa Scheffers-van Schayck|
|- Sponsor/Initiator ||Trimbos-institute - Netherlands Institute of Mental Health and Addiction|
(Source(s) of Monetary or Material Support)
|Dutch Cancer Society|
|- Brief summary||The aim of this study is to conduct an implementation 2-arm randomized controlled trial to examine the effectiveness of a proactive telephone counseling for smoking parents (N = 360) in the Netherlands. By using three different recruitment strategies (i.e., primary schools, maternity centers, and medical professionals) we will examine facilitators and barriers for these recruitment strategies, test whether these recruitment strategies have a differential effect on the effectiveness of the intervention, and test the cost-effectiveness of the intervention. Finally, an implementation will be developed that provides information on how this intervention can be implemented in the most optimal manner.|
|- Main changes (audit trail)|
|- RECORD||19-sep-2016 - 11-nov-2016|