Smoking Cessation for Fathers of Sick Children

Official title

mHealth-based Motivational Counselling Integrate With a Sample of Nicotine Replacement Therapy for Fathers of Sick Children Who Smoke Cigarettes: A Pilot Randomized Controlled Trial

Overview

The project aims to develop and examine the feasibility, acceptability, and preliminary effectiveness of a proactive intervention model combined brief advice, nicotine replacement therapy sampling and mHealth-based individual counselling in increasing smoking abstinence for fathers of sick children.

Detailed description

Targeted participants are fathers of sick children who smoke daily in the past 7 days and live together with their children. The primary caregiver will be selected if both parents smoke. Participants will be recruited from pediatric wards/outpatient departments of Queen Mary Hospital (QMH), a major acute hospital in Hong Kong. The recruitment will be extended to other public hospitals if needed.

This study will be a two-arm, parallel pilot randomized trial with follow-ups at 1-, 3-, and 6-month since enrolment using standard methodology (CONSORT) to evaluate the effectiveness of the intervention. Surveys will be collected via telephone and children's saliva will be collected face-to-face at 3-months and 6-months after randomisation using Alere iScreen OFD saliva cotinine test device. Semi-structured individual telephone or face-to-face in-depth interviews will be conducted with the participants in the intervention group at 6 months follow-up to explore the participants' perception towards the intervention.

This study's clinical outcome will be biochemically validated abstinence at 3 months after randomisation. Secondary outcomes include validated abstinence at 6 months after randomisation, self-reported 7-day point prevalence abstinence (PPA), 24-hour quit attempts, and smoking reduction by at least 50% at 3 and 6 months. Incentives of HK$200 will be given to participants who report 7-day PPA at 1 month post randomisation. Additionally, incentives of HK$ 500 will be provided for the completion of each biochemical validation (a total $1000 for validation at 3- and 6-month). Such an amount can increase the response rate in our experience. Another incentive of $200 will be given to subjects completing qualitative interviews.

Interventions

• Behavioral Nicotine Replacement Therapy (NRT) Sampling
  Participants will be advised to choose the NRT according to their preferences and daily cigarette consumption. Cigarette consumption of ≤20 daily will receive the 14mg patch or 2mg gum and participants consume \>20 cigarettes daily will receive the 21mg patch. An NRT use card (Appendix 6 draft) containing the instructions and potential side effects were given with a brief oral explanation. Full course of pharmacological treatment for 12-week are available in smoking cessation services. Participa
• Behavioral mHealth-based motivational counselling
  The mHealth intervention will be delivered via the most popular instant messaging app in Hong Kong (WhatsApp). A total of 24 messages with contents including the harms of smoking and smoke exposure for children, encouragement, benefits of quitting for children, methods of quitting, dealing with craving, and measures to reduce cigarette smoke exposure at home will be provided. The messages will be scheduled in a tapering schedule that participants will receive 5 messages in the first week, then c
• Behavioral Brief cessation advice and self-help material
  At baseline, participants will receive brief face-to-face advice on quitting smoking for the health of the children using the validated AWARD model (Ask, Warn, Advise, Refer, Do-it-again) with a print-based self-help material providing detailed information on health hazards of SHS exposure on children, methods to deal with craving and withdrawal symptoms, and measures on preventing SHS exposure for children at home.

Primary outcome measures

• Biochemically validated abstinence [Time frame: 3-months follow-ups]

Secondary outcome measures (12)

• Biochemically validated abstinence [Time frame: 6-month follow-up]
• Past 7-day point prevalence abstinence (PPA) [Time frame: 3-month follow-up]
• Past 7-day point prevalence abstinence (PPA) [Time frame: 6-month follow-up]
• Smoking reduction [Time frame: 3-month follow-up]
• Smoking reduction [Time frame: 6-month follow-up]
• Use of smoking cessation services [Time frame: 3-month follow-up]
• Use of smoking cessation services [Time frame: 6-month follow-up]
• Respiratory symptoms [Time frame: 3-month follow-up]
• Respiratory symptoms [Time frame: 6-month follow-up]
• Perceived family well-being [Time frame: 3-month follow-up]
• Perceived family well-being [Time frame: 6-month follow-up]
• Self-reported life quality [Time frame: 3-month follow-up]

Eligibility criteria

Inclusion criteria for parents：

• Parents (mainly fathers) aged ≥18 years and smoke at least one cigarette (including alternative tobacco products) daily in the past seven days
• Living with a child aged <18 years who attended the clinic or were admitted to the pediatric ward
• Hong Kong residents able to read and communicate in Cantonese or Putonghua
• Owned a smartphone and can use an instant messaging app (e.g., WhatsApp, Facebook) Inclusion criteria for children
• Children aged <18 years who attended the clinic or were admitted to the pediatric ward
• Lives with at least one or more parents who smoke at least one cigarette (including alternative tobacco products) daily in the past seven days
• Able to provide biochemical samples (e.g. saliva) for purpose of research

Exclusion criteria for parents

• Smokers having a history of psychiatric/psychological disease or currently on regular psychotropic medications
• Smokers using smoking cessation medications or other smoking cessation services or projects Exclusion criteria for children
• Children who already have serious health diseases (e.g.chronic disease, genetic disease)
• Children who are participating in other clinical trials that may affect the results of this study
• Children who live in certain environments, such as those living in highly contaminated areas or areas with other potential disease-causing factors

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

Hong Kong · 1 center

• School of Nursing, The University of Hong Kong — Hong Kong

Identifiers

NCT: NCT07014124 · Sick Children

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗