Smoking Cessation
Conditions
Brief summary
This study will test the efficacy of a cessation intervention for caregivers in a large, inner-city Pediatric Emergency Department. The investigators will randomize 750 caregivers who smoke who present to our Pediatric Emergency Department with their child who has a Second Hand Smoke exposure-related illness to either one of two conditions: 1) Screening, Brief Intervention, and Assisted Referral to Treatment (SBIRT); or 2) Healthy Habits Control (HHC). The Screening, Brief Intervention, and Assisted Referral to Treatment condition will include a brief form of the Clinical Practice Guideline: Treating Tobacco Use and Dependence, motivational interviewing, engaging and personalized materials on the effects of smoking and Second Hand Smoke exposure, immediate access to caregivers' choice of cessation resources (e.g., Quitline, smokefree.gov, or txt2quit), a 12-week supply of nicotine replacement therapy and weekly booster materials for 12 weeks. The Healthy Habits Control program will be used as an attention control in which caregivers will receive instruction on healthy lifestyle choices to improve the child's health.
Detailed description
This study will test the efficacy of a cessation intervention for caregivers in a large, inner-city Pediatric Emergency Department. The proposed Screening, Brief Intervention, and Assisted Referral to Treatment will highlight the effects of Second Hand Smoke exposure on the child's health. the investigators will randomize 750 caregivers who smoke who present to our Pediatric Emergency Department with their child who has a Second Hand Smoke exposure related illness to either one of two conditions: 1) Screening, Brief Intervention, and Assisted Referral to Treatment; or 2) Healthy Habits Control. The Screening, Brief Intervention, and Assisted Referral to Treatment condition will use components shown to be effective in the out-patient setting but not yet tested in the Pediatric Emergency Department setting. It will include a brief form of the Clinical Practice Guideline: Treating Tobacco Use and Dependence, motivational interviewing, engaging and personalized materials on the effects of smoking and Second Hand Smoke exposure, immediate access to caregivers' choice of cessation resources (e.g., Quitline, smokefree.gov, or txt2quit), a 12-week supply of nicotine replacement therapy and weekly booster materials for 12 weeks. The Healthy Habits Control program has been previously developed and used in the out-patient setting, and will be used as an attention control in which caregivers will receive instruction on healthy lifestyle choices to improve their child's health. Cessation assistance will be offered at the study's conclusion. If effective, the Screening, Brief Intervention, and Assisted Referral to Treatment model could be routinely used in the Pediatric Emergency Department setting, which could reach at least one million smokers a year, and could result in significant reductions in caregivers' tobacco use, Second Hand Smoke exposure related pediatric illness, and costs in this population. In addition, the investigators' results will inform the conduct of public health research efforts aimed at adults via the Pediatric Emergency Department.
Interventions
BEHAVIORALSBIRT
The Social Worker will provide caregivers with the brief (10-15 minute) Advise, Assess, Assist intervention based on the Clinical Practice Guidelines, and tailored on levels of motivation to quit and tobacco dependence. Patients in this group will receive Nicotine Replacement Therapy vouchers, immediate connection to cessation resources, and intervention materials.
BEHAVIORALHHC
The Social Worker will provide caregivers with the brief (10-15 minute) Lets Go! 5-2-1-0 intervention which is a child obesity prevention program. Patients in this group will receive motivational interviewing in regards to helping children and families eat healthy and be active. This group will receive water bottle vouchers, immediate connection to 5-2-1-0 resources, and intervention materials.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Environmental Health Sciences (NIEHS)
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Eligible participants must: 1. be \> age 18; 2. be accompanying a child 0-17 years of age who is presenting to the Pediatric Emergency Department with: * a stable condition, that is, patients who are not critically ill and do not require immediate treatment and intervention by the Pediatric Emergency Department practitioner and * a potentially Second Hand Smoke exposure related chief complaint (such as wheezing, difficulty breathing, cough) as outlined by the U.S. Surgeon General;45 3. be a daily smoker; 4. have currently or recently smoked inside their home; 5. speak and read English, and 6. have a permanent address and a working cell or landline number. 7. Live within a 50 mile radius. 8. Child is a non-smoker.
Exclusion criteria
Caregivers will be excluded if 1. their child has a tracheostomy or 2. if the caregivers are tobacco chewers only, 3. if the caregivers are using pharmacologic cessation treatment, 4. or plan to move within the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Self-reported Prolonged Abstinence at 6 Weeks | 6 weeks post enrollment | Primary outcomes are self-reported prolonged abstinence at 6-weeks post-enrollment, validated in all participants via salivary cotinine levels. |
| Percentage of Participants With Self-reported Prolonged Abstinence at 6 Months | 6months post enrollment | Primary outcomes are self-reported prolonged abstinence at 6 months post-enrollment, validated in all participants via salivary cotinine levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Quit Attempts at 6 Weeks | 6 weeks post enrollment | Secondary outcomes include number of quit attempts at 6 weeks post enrollment. |
| Number of Quit Attempts at 6 Months | 6 months post enrollment | Secondary outcomes include number of quit attempts at 6 months post enrollment. |
| Readiness to Quit at 6 Weeks | 6 weeks post enrollment | Secondary outcomes include readiness to quit at 6 weeks post enrollment as measured by a readiness to quit scale. Scale name: The Contemplation Ladder Reference: Biener L., Abrams D.B. The Contemplation Ladder: Validation of a measure of readiness to consider smoking cessation. Health Psychol. 1991;10:360-365. doi: 10.1037/0278-6133.10.5.360. What scale measures: the smoker's motivation to quit smoking. The Contemplation Ladder is a validated score that correlates with the likelihood of making a quit attempt and participation in activities associated with quit attempts. The Contemplation Ladder is a 1-item, 11-point scale of motivation to quit. The question asks: Mark the number that shows how you feel about quitting. Minimum score: 0 = no thought of quitting Maximum score: 10= taking action to quit Lower scores indicate worse outcomes. Higher scores indicate better outcomes. There are no subscales and one score is chosen by the smoker. |
| Change From Baseline in the Number of Cigarettes Smoked Per Day at 6 Weeks | baseline and 6 weeks post enrollment | Secondary outcomes include number of cigarettes smoked at 6 weeks post enrollment. This number is reporting a change in the number of cigarettes smoked between baseline and six weeks. |
| Use of Cessation Resources at 6 Weeks | 6 weeks post enrollment | Secondary outcomes include use of cessation resources at 6 weeks post enrollment. |
| Use of Cessation Resources at 6 Months | 6 months post enrollment | Secondary outcomes include use of cessation resources at 6 months post enrollment. |
| Readiness to Quit at 6 Months | 6 months post enrollment | Secondary outcomes include readiness to quit at 6 months post enrollment as measured by a readiness to quit scale. Scale name: The Contemplation Ladder Reference: Biener L., Abrams D.B. The Contemplation Ladder: Validation of a measure of readiness to consider smoking cessation. Health Psychol. 1991;10:360-365. doi: 10.1037/0278-6133.10.5.360. What scale measures: the smoker's motivation to quit smoking. The Contemplation Ladder is a validated score that correlates with the likelihood of making a quit attempt and participation in activities associated with quit attempts. The Contemplation Ladder is a 1-item, 11-point scale of motivation to quit. The question asks: Mark the number that shows how you feel about quitting. Minimum score: 0 = no thought of quitting Maximum score: 10= taking action to quit Lower scores indicate worse outcomes. Higher scores indicate better outcomes. There are no subscales and one score is chosen by the smoker. |
| Change From Baseline in the Number of Cigarettes Smoked Per Day at 6 Months | baseline and 6 months post enrollment | Secondary outcomes include number of cigarettes smoked at 6 months post enrollment as compared with baseline. |
Countries
United States
Participant flow
Pre-assignment details
The numbers listed below represent a dyad (child participant/caregiver participant).
Participants by arm
| Arm | Count |
|---|---|
| Healthy Habits Control The Healthy Habits Control program has been previously developed and used in the out-patient setting, and will be used as an attention control in which caregivers will receive instruction on healthy lifestyle choices to improve their child's health. Cessation assistance will be offered at the study's conclusion.
HHC: The Social Worker will provide caregivers with the brief (10-15 minute) Lets Go! 5-2-1-0 intervention which is a child obesity prevention program. Patients in this group will receive motivational interviewing in regards to helping children and families eat healthy and be active. This group will receive water bottle vouchers, immediate connection to 5-2-1-0 resources, and intervention materials. | 373 |
| SBIRT An assessment form, motivational interviewing, personalized educational materials, immediate access to cessation resources, a 12-week supply of nicotine replacement therapy and weekly booster materials for 12 weeks.
nicotine
SBIRT: The Social Worker will provide caregivers with the brief (10-15 minute) Advise, Assess, Assist intervention based on the Clinical Practice Guidelines, and tailored on levels of motivation to quit and tobacco dependence. Patients in this group will receive Nicotine Replacement Therapy vouchers, immediate connection to cessation resources, and intervention materials. | 377 |
| Total | 750 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 7 | 8 |
Baseline characteristics
| Characteristic | Healthy Habits Control | SBIRT | Total |
|---|---|---|---|
| Age, Categorical Caregiver participants <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Caregiver participants >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Caregiver participants Between 18 and 65 years | 373 Participants | 377 Participants | 750 Participants |
| Age, Categorical Child Participants <=18 years | 373 Participants | 377 Participants | 750 Participants |
| Age, Categorical Child Participants >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Child Participants Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous Caregiver Participants | 32.59 years STANDARD_DEVIATION 7.06 | 33.12 years STANDARD_DEVIATION 8.2 | 32.89 years STANDARD_DEVIATION 7.67 |
| Age, Continuous Child Participants | 4.73 years STANDARD_DEVIATION 4.51 | 5.12 years STANDARD_DEVIATION 4.89 | 4.92 years STANDARD_DEVIATION 4.7 |
| Ethnicity (NIH/OMB) Caregiver Participants Hispanic or Latino | 9 Participants | 8 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Caregiver Participants Not Hispanic or Latino | 363 Participants | 368 Participants | 731 Participants |
| Ethnicity (NIH/OMB) Caregiver Participants Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Child Participants Hispanic or Latino | 4 Participants | 8 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Child Participants Not Hispanic or Latino | 369 Participants | 368 Participants | 737 Participants |
| Ethnicity (NIH/OMB) Child Participants Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Caregiver Participants American Indian or Alaska Native | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Caregiver Participants Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregiver Participants Black or African American | 200 Participants | 200 Participants | 400 Participants |
| Race (NIH/OMB) Caregiver Participants More than one race | 18 Participants | 23 Participants | 41 Participants |
| Race (NIH/OMB) Caregiver Participants Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Caregiver Participants Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Caregiver Participants White | 150 Participants | 152 Participants | 302 Participants |
| Race (NIH/OMB) Child Participants American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Child Participants Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Child Participants Black or African American | 215 Participants | 215 Participants | 430 Participants |
| Race (NIH/OMB) Child Participants More than one race | 8 Participants | 15 Participants | 23 Participants |
| Race (NIH/OMB) Child Participants Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Child Participants Unknown or Not Reported | 7 Participants | 9 Participants | 16 Participants |
| Race (NIH/OMB) Child Participants White | 142 Participants | 137 Participants | 279 Participants |
| Region of Enrollment United States | 373 participants | 377 participants | 750 participants |
| Sex: Female, Male Caregiver Participants Female | 321 Participants | 330 Participants | 651 Participants |
| Sex: Female, Male Caregiver Participants Male | 52 Participants | 47 Participants | 99 Participants |
| Sex: Female, Male Child Participants Female | 177 Participants | 185 Participants | 362 Participants |
| Sex: Female, Male Child Participants Male | 196 Participants | 192 Participants | 388 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 377 | 0 / 373 |
| other Total, other adverse events | 0 / 377 | 0 / 373 |
| serious Total, serious adverse events | 0 / 377 | 0 / 373 |
Outcome results
Primary
Percentage of Participants With Self-reported Prolonged Abstinence at 6 Months
Primary outcomes are self-reported prolonged abstinence at 6 months post-enrollment, validated in all participants via salivary cotinine levels.
Time frame: 6months post enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SBIRT | Percentage of Participants With Self-reported Prolonged Abstinence at 6 Months | 12.9 percentage of participants |
| Healthy Habits Control | Percentage of Participants With Self-reported Prolonged Abstinence at 6 Months | 8.3 percentage of participants |
Primary
Percentage of Participants With Self-reported Prolonged Abstinence at 6 Weeks
Primary outcomes are self-reported prolonged abstinence at 6-weeks post-enrollment, validated in all participants via salivary cotinine levels.
Time frame: 6 weeks post enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SBIRT | Percentage of Participants With Self-reported Prolonged Abstinence at 6 Weeks | 4.2 percentage of participants |
| Healthy Habits Control | Percentage of Participants With Self-reported Prolonged Abstinence at 6 Weeks | 4.2 percentage of participants |
Secondary
Change From Baseline in the Number of Cigarettes Smoked Per Day at 6 Months
Secondary outcomes include number of cigarettes smoked at 6 months post enrollment as compared with baseline.
Time frame: baseline and 6 months post enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SBIRT | Change From Baseline in the Number of Cigarettes Smoked Per Day at 6 Months | -4 cigarettes per week |
| Healthy Habits Control | Change From Baseline in the Number of Cigarettes Smoked Per Day at 6 Months | -2 cigarettes per week |
Secondary
Change From Baseline in the Number of Cigarettes Smoked Per Day at 6 Weeks
Secondary outcomes include number of cigarettes smoked at 6 weeks post enrollment. This number is reporting a change in the number of cigarettes smoked between baseline and six weeks.
Time frame: baseline and 6 weeks post enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SBIRT | Change From Baseline in the Number of Cigarettes Smoked Per Day at 6 Weeks | -2 cigarettes per week |
| Healthy Habits Control | Change From Baseline in the Number of Cigarettes Smoked Per Day at 6 Weeks | 0 cigarettes per week |
Secondary
Number of Quit Attempts at 6 Months
Secondary outcomes include number of quit attempts at 6 months post enrollment.
Time frame: 6 months post enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SBIRT | Number of Quit Attempts at 6 Months | 3.82 quit attempts | Standard Deviation 6.4 |
| Healthy Habits Control | Number of Quit Attempts at 6 Months | 2.3 quit attempts | Standard Deviation 3.2 |
Secondary
Number of Quit Attempts at 6 Weeks
Secondary outcomes include number of quit attempts at 6 weeks post enrollment.
Time frame: 6 weeks post enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SBIRT | Number of Quit Attempts at 6 Weeks | 2.69 quit attempts | Standard Deviation 5 |
| Healthy Habits Control | Number of Quit Attempts at 6 Weeks | 2.22 quit attempts | Standard Deviation 2.5 |
Secondary
Readiness to Quit at 6 Months
Secondary outcomes include readiness to quit at 6 months post enrollment as measured by a readiness to quit scale. Scale name: The Contemplation Ladder Reference: Biener L., Abrams D.B. The Contemplation Ladder: Validation of a measure of readiness to consider smoking cessation. Health Psychol. 1991;10:360-365. doi: 10.1037/0278-6133.10.5.360. What scale measures: the smoker's motivation to quit smoking. The Contemplation Ladder is a validated score that correlates with the likelihood of making a quit attempt and participation in activities associated with quit attempts. The Contemplation Ladder is a 1-item, 11-point scale of motivation to quit. The question asks: Mark the number that shows how you feel about quitting. Minimum score: 0 = no thought of quitting Maximum score: 10= taking action to quit Lower scores indicate worse outcomes. Higher scores indicate better outcomes. There are no subscales and one score is chosen by the smoker.
Time frame: 6 months post enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SBIRT | Readiness to Quit at 6 Months | 7.03 units on a scale | Standard Deviation 2.6 |
| Healthy Habits Control | Readiness to Quit at 6 Months | 6.77 units on a scale | Standard Deviation 2.8 |
Secondary
Readiness to Quit at 6 Weeks
Secondary outcomes include readiness to quit at 6 weeks post enrollment as measured by a readiness to quit scale. Scale name: The Contemplation Ladder Reference: Biener L., Abrams D.B. The Contemplation Ladder: Validation of a measure of readiness to consider smoking cessation. Health Psychol. 1991;10:360-365. doi: 10.1037/0278-6133.10.5.360. What scale measures: the smoker's motivation to quit smoking. The Contemplation Ladder is a validated score that correlates with the likelihood of making a quit attempt and participation in activities associated with quit attempts. The Contemplation Ladder is a 1-item, 11-point scale of motivation to quit. The question asks: Mark the number that shows how you feel about quitting. Minimum score: 0 = no thought of quitting Maximum score: 10= taking action to quit Lower scores indicate worse outcomes. Higher scores indicate better outcomes. There are no subscales and one score is chosen by the smoker.
Time frame: 6 weeks post enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SBIRT | Readiness to Quit at 6 Weeks | 6.98 units on a scale | Standard Deviation 2.5 |
| Healthy Habits Control | Readiness to Quit at 6 Weeks | 6.46 units on a scale | Standard Deviation 2.8 |
Secondary
Use of Cessation Resources at 6 Months
Secondary outcomes include use of cessation resources at 6 months post enrollment.
Time frame: 6 months post enrollment
Population: Data were not collected.
Secondary
Use of Cessation Resources at 6 Weeks
Secondary outcomes include use of cessation resources at 6 weeks post enrollment.
Time frame: 6 weeks post enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SBIRT | Use of Cessation Resources at 6 Weeks | 53 Percentage of caregivers |
| Healthy Habits Control | Use of Cessation Resources at 6 Weeks | 0 Percentage of caregivers |