Clinical trial NCT03879889: Smoking Reduction Intervention for Smoking Parents of Paediatric Patients in Hong Kong
Official title: Smoking Reduction Intervention for Smoking Parents of Paediatric Patients in Hong Kong: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking, Tobacco
Keywords: Smoking reduction
Randomised controlled trial
Motivational interview
Nicotine replacement therapy
Environmental tobacco smoke exposure
Paediatrics
Children
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 210
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single blinded randomized controlled trial aiming to evaluate the effectiveness of smoking reduction interventions for smoking parents in paediatric hospital setting in Hong Kong. This trial consists of a 24-week intervention period. Eligible families will be randomly assigned to either intervention group or control group. Smoking parent(s) in intervention group will be given face-to-face counselling on smoking reduction and adherence to nicotine replacement therapy (NRT) with motivational interviews, provision of NRT and monthly phone follow-up for counselling and support. Smoking parent(s) in control group will be given standard advice and information on smoking cessation.
Primary purpose: TREATMENT

Brief summary: A randomized controlled trial to evaluate the effectiveness of smoking reduction interventions for smoking parents in paediatric hospital setting in Hong Kong.

Detailed description: This is a single blinded randomized controlled trial aiming to evaluate the effectiveness of smoking reduction interventions for smoking parents in paediatric hospital setting in Hong Kong. This trial consists of a 24-week intervention period. Eligible families will be randomly assigned to either intervention group or control group. Smoking parent(s) in intervention group will be given face-to-face counselling on smoking reduction and adherence to nicotine replacement therapy (NRT) with motivational interviews, provision of NRT and monthly phone follow-up for counselling and support. Smoking parent(s) in control group will be given standard advice and information on smoking cessation.

Eligibility criteria: Inclusion Criteria:

* Ethnic Chinese family with children aged younger than 18 years of age.
* Children who are admitted to the paediatric inpatient units or attend the paediatric specialist clinic at the Prince of Wales Hospital.
* Children with at least one custodial smoking parent who is living with them.
* Written informed consent obtained from parents.

Exclusion Criteria:

* Families not residing in Hong Kong.
* Children in foster care.
* Children with unclear custody.
* Smoking paediatric patients.
* Presence of smoking household members apart from the parents.
* Smoking parent who is contraindicated to use nicotine replacement therapy.

Primary outcomes:
measure: Validated successful smoking reduction rate
timeFrame: Week-24
measure: Self-reported parental successful smoking reduction rate at week-24
timeFrame: Week-24
Secondary outcomes:
measure: Urinary cotinine validated parental smoking cessation rate at week-24
timeFrame: Week-24
measure: Parental self-reported smoking reduction rate of cigarette consumption
timeFrame: Week-24
measure: Parental self-reported smoking cessation rate of cigarette consumption
timeFrame: Week-24
measure: Change in children's urinary cotinine level from baseline to week-24
timeFrame: Week-24
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Ching Ching Chan, FHKAM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dai S, Chan MHM, Kam RKT, Li AM, Au CT, Chan KC. Monthly Motivational Interview Counseling and Nicotine Replacement Therapy for Smoking Parents of Pediatric Patients: A Randomized Controlled Trial. Front Pediatr. 2022 Apr 13;10:798351. doi: 10.3389/fped.2022.798351. eCollection 2022.