An Intervention to Protect Young Children From Tobacco Smoke Exposure

Laura J. Rosen

Status and phase: Unknown; Phase 3

Conditions: Passive Smoking

Treatments: Behavioral: Behavioral Late; Behavioral: Behavioral Early

Study type: Interventional

Funder types: Other

Identifiers

NCT02867241

0143-16ASF

Details and patient eligibility

About

The primary goal of this research is to evaluate the effectiveness of an intervention for parents to reduce tobacco smoke exposure of young children

Full description

The primary aim of this intervention is to reduce exposure of children to tobacco smoke, through an intervention program designed to help parents better perceive exposure and its harms, and to provide tools for assisting them in protecting children. Secondary aims are to understand the relationships between parentally-reported and objectively measured child tobacco smoke exposure, to assess the relationship between tobacco smoke exposure and health and health care utilization, and to better understand parental perceptions of tobacco smoke exposure (PPE) and parental perceptions of risk (PPR) from tobacco smoke exposure. The effectiveness of the intervention will be evaluated using a randomized controlled trial.

This RCT is a continuation of previous work. Originally the entire research project, which included a Pilot Study and a Randomized Controlled Trial (RCT) was registered as NCT01335178. Upon completion of the Pilot Study, we closed NCT01335178 and opened a new one for the RCT with the current registration number.

Enrollment: 160 patients

Sex: All

Ages: Under 8 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for RCT :

1. • Families in which at least one parent smokes, and both parents combined smoke a minimum of 10 cigarettes per week
2. • Parents willing to provide child hair samples
3. • Hebrew speaking participants
4. • Parents are willing to participate from time of entry for the coming 8 months .

Exclusion Criteria:

There are no additional exclusion criteria

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 3 patient groups

Intervention

Experimental group

Description:

1. Motivational interviews (3 visits) + supportive phone calls 2. Feedback of child hair nicotine levels 3. Feedback of home air quality (PM2.5) 4. New Media (Website and/or Facebook with information and parental forum)

Treatment:

Behavioral: Behavioral Early

Control Regular

Other group

Description:

This group will get no intervention during the study period. Following the close of the study, participants in this group will receive a shortened version of the intervention (1 motivational interview, with feedback on child hair nicotine levels and feedback on home air quality (PM2.5))

Treatment:

Behavioral: Behavioral Late

Control Expanded

Other group

Description:

This group will get no intervention during the study period. However, participants will fill out a detailed questionnaire on parental perceptions of exposure and risk, as well as questions on social norms, self-efficacy, and knowledge Following the close of the study, participants in this group will receive a shortened version of the intervention (1 motivational interview, with feedback on child hair nicotine levels and feedback on home air quality (PM2.5))

Treatment:

Behavioral: Behavioral Late