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De implementatie van een effectieve interventie om te stoppen met roken voor ouders.


- candidate number25313
- NTR NumberNTR6092
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-sep-2016
- Secondary IDs2015-7944 
- Public TitleDe implementatie van een effectieve interventie om te stoppen met roken voor ouders.
- Scientific TitleRecruitment strategies for an effective smoking cessation program for parents
- ACRONYMN.A.
- hypothesisIt 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 two different implementation routes (i.e., through [youth] health care professionals and via a mass media approach [i.e., online mass media and mass mailings through primary schools]). In addition, a process evaluation for both implementation routes will be conducted;
2. test the (cost)effectiveness of the intervention and the extent to which the implementation routes have a differential effect on the main outcome;
3. to develop an implementation plan based on the information obtained from the various analyses and process evaluation.
- Healt Condition(s) or Problem(s) studiedSmoking, Parents
- Inclusion criteria1) 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 criteriaN.A.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-sep-2016
- planned closingdate31-dec-2018
- Target number of participants144
- InterventionsIn 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 outcomeThe primary outcome measures is 7-day point prevalence abstinence at twelve months post-intervention.
- Secondary outcomeSecondary 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).
- TimepointsAll 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 sitewww.rookvrijeouders.nl / www.rokeninfo.nl/publiek/rookvrijeouders
- statusopen: 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
- Funding
(Source(s) of Monetary or Material Support)
Dutch Cancer Society
- PublicationsN.A.
- Brief summaryThe 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 = 144) in the Netherlands. By using two different implementation routes (i.e., through [youth] healthcare and via a mass media approach) we will examine facilitators and barriers for these implementation routes, test whether these implementation routes 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)15-dec-2017 -IK:

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."

replaced by

"1) being at least a weekly smoker;
2) being a parent/caretaker of a child between 0 and 18 years old;
3) having the intention to quit smoking (currently or in the future);
4) giving informed consent for participation."


Exclusion criteria:
"Women who are pregnant will be excluded. Telephone counseling will be offered to them." was added.


Primary outcome:
"The primary outcome measures is 7-day point prevalence abstinence at twelve months post-intervention."

replaced by

"The primary outcome measures is 7-day point prevalence abstinence at three 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)."

replaced by

"Secondary outcome measures include: 
1) occurrence of at least 24 hours abstinence at some point during the study;
2) 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);
3) increase in motivation to quit; 
4) number and duration of quit attempts; 
5) use of and adherence to nicotine replacement therapy;
6) implementation of smoking restrictions at home; 
7) 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."

replaced by

"All outcome measures will be assessed in online questionnaires. 
The primary outcome measures will be assessed at three months post-intervention.
  Secondary outcome measures:
1) occurrence of at least 24 hours abstinence at some point during the study will be assessed at three months post- intervention;
2) 4-week quitter will be assessed at three months-post intervention;
3) increase in motivation to quit will be assessed at baseline and three months post-intervention;
4) number and duration of quit attempts will be assessed at baseline and, three months post-intervention, and twelve months post-intervention; 
5) use of and adherence to nicotine replacement therapy will be assessed at three months post-intervention;
6) implementation of smoking restrictions at home will be assessed at baseline and three months post-intervention;
7) change in smoking-related cognitions will be assessed at baseline and three months post-intervention."
- RECORD19-sep-2016 - 15-dec-2017


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