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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD078332 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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Investigators will examine whether adding financial incentives and nicotine replacement dual therapy to current best practices for smoking cessation (i.e. referral to counseling using a telephone quit line) increases cessation rates in mothers and reduces second-hand smoke exposure in children. While perhaps more expensive upfront compared to best practices alone, the investigators hypothesize that this treatment approach will be a more cost-effective cessation intervention.
Smoking prevalence among disadvantaged mothers remains at strikingly high levels (40-60%). Disadvantaged women are more likely to begin smoking at an earlier age, be heavier smokers, be nicotine dependent, and fail in their efforts to quit smoking (Kandel et al., 2009). These women and their children also suffer higher rates of smoking-related adverse health consequences.
Despite widespread knowledge of the harmful effects of secondhand smoke exposure (SHSe), estimates are that 85% of children from low-income U.S. families experience chronic exposure. Children exposed to SHS are at increased risk for numerous serious health problems, including sudden infant death syndrome, more severe asthma, lower respiratory infections, and chronic middle ear disease, and maternal smoking is a particularly significant contributor to this increased morbidity and mortality. SHSe is also a substantial economic burden on the U.S. healthcare system, being estimated to increase direct medical and life-lost costs by > $5 billion annually.
Interventions developed to reduce children's SHSe have aimed to (1) decrease parental smoking around their children, (2) increase parental smoking cessation, or (3) both. Since smoking by a child's mother is a particularly significant contributor to SHSe, interventions have typically targeted smoking mothers. Regarding efforts to decrease smoking around children, studies testing relatively low-intensity interventions (e.g., written materials, brief advice) have failed to change exposure levels, while those testing more intensive interventions have had more success decreasing children's SHSe, with at least some instances of biochemically-verified changes.
Clearly, more effective smoking-cessation interventions for mothers are needed to meet the public health priority of reducing SHSe among children. The investigators recognize that maternal smoking cessation will not eliminate SHSe among children since many (~40%) live with more than one smoker. However, the evidence is clear that smoking mothers are the primary contributors to their children's SHSe, making them the obvious first target. The overarching goal of this project is to develop an efficacious, cost-effective incentive-based smoking cessation intervention that is combined with state-of-the-art smoking-cessation pharmacotherapy practices to optimize outcomes.
Participants will be 250 mothers (10 pilot and 80 per treatment condition) recruited from our university-affiliated hospital's pediatric practice, other pediatric and family medicine practices throughout the county in which our clinic is located, local offices for Women, Infants, and Children (WIC), and other recruitment strategies (e.g., ads on Facebook). Participants will be randomly assigned to one of three treatment conditions: (1) usual care for smoking cessation and protecting children from SHSe, (2) usual care combined with incentives for objectively verified smoking abstinence, and (3) usual care combined with incentives and pharmacotherapy using innovative procedures to enhance its efficacy.
The investigators believe combining pharmacotherapies with incentives could be an effective strategy for surmounting adherence problems in this population by assuring that women have regular contact with clinic staff and thereby providing staff opportunities to problem-solve obstacles that may have arisen around adherence or side effects and to regularly underscore the importance and potential benefits of using the medications as prescribed.
The investigators hypothesize that each of the interventions with incentives will increase smoking abstinence compared to usual care alone, but that the largest magnitude and most cost-effective treatment effects will be achieved by combining incentives with pharmacotherapy. They also hypothesize that (a) both incentives interventions will decrease child cotinine levels significantly more than usual care alone and (b) that SHSe levels will be significantly lower among children of abstainers than smokers.
Taken together, developing efficacious and cost-effective interventions to increase smoking cessation interventions among disadvantaged mothers and reducing SHSe among their children is an important U.S. public health priority. The financial incentives model is effective with other treatment-recalcitrant populations and we believe has the potential to meet this important public-health challenge. Behavioral-economic theory suggests that the efficacy of the cessation intervention is at least in part attributable to providing smaller, more immediate incentives for success that act to bridge the temporal delay to the larger naturalistic rewards of improved health outcomes for mother and child. The investigators will continue to investigate the behavioral-economic processes involved in smoking among disadvantaged women and in individual differences in treatment response. Lastly, there is rapidly growing interest in the use of incentives to promote healthy behavior change in disadvantaged populations. The proposed project and others like it will be important to assuring that the necessary scientific knowledge is available to support that effort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Best practices | Experimental | Participants will receive the Five As plus a referral to a quit line. |
|
| Best practices and financial incentives | Experimental | Participants will receive the Five As, a referral to a quit line, and financial incentives contingent on biochemically confirmed smoking abstinence |
|
| Best practices, financial incentives, and NRT | Experimental | Participants will receive the Five As, a referral to a quit line, financial incentives contingent on biochemically confirmed smoking abstinence, and nicotine replacement therapy (NRT) provided in the form of both nicotine patches and gum/lozenge for dual therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practices | Behavioral | Five As plus referral to a quit line |
|
| Measure | Description | Time Frame |
|---|---|---|
| 7-day Point Prevalence Smoking Abstinence Levels | Point prevalence abstinence will be defined as self-report of no smoking in the past 7 days, not even a puff, with biochemical verification via breath carbon monoxide (CO) and urine cotinine. Abstinence at the 12-week (end of treatment) and 24-week assessment will be compared between the three treatment arms. | Collected once per woman at approximately 12- and 24- weeks following quit date in each of the three smoking arms |
| Objective Measure of Child Secondhand Smoke Exposure (SHSe) | SHSe will be defined as the level of cotinine measured in the urine of the youngest child at baseline, 6-, 12-, and 24-weeks following the mother's quit date. SHSe outcomes will be compared between the three treatment arms and between children of abstainers versus smokers independent of treatment condition. We hypothesize being able to detect greater reductions from baseline levels in the incentives compared to Best Practices treatment conditions and among abstainers compared to smokers. We report main effects of treatment condition as geometric means (+/- SEM) collapsed across the three assessment times for each treatment condition controlling for baseline values. | Collected twice per child at baseline, and once at approximately 6-, 12- and 24-weeks following quit date |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous Abstinence | Continuous abstinence will be defined as self-report of no smoking in the past 7 days at each time point, not even a puff, with biochemical verification via breath CO and urine cotinine. Continuous abstinence from quit date through 24 week assessment will be compared between the three treatment arms. | 24 weeks following quit date |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Outpatient Child Visits to Healthcare Center. | Number of outpatient child visits will be compared between the three treatment arms and between abstainers versus smokers, independent of treatment condition. | 48 weeks following quit date. |
| Number of Inpatient Child Visits to Healthcare Center. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen T Higgins, PhD | University of Vermont | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37527730 | Derived | Higgins ST, Plucinski S, Orr E, Nighbor TD, Coleman SRM, Skelly J, DeSarno M, Bunn J. Randomized clinical trial examining financial incentives for smoking cessation among mothers of young children and possible impacts on child secondhand smoke exposure. Prev Med. 2023 Nov;176:107651. doi: 10.1016/j.ypmed.2023.107651. Epub 2023 Jul 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Best Practices | Participants will receive the Five As plus a referral to a quit line. Best Practices: Five As plus referral to a quit line |
| FG001 | Best Practices and Financial Incentives | Participants will receive the Five As, a referral to a quit line, and financial incentives contingent on biochemically confirmed smoking abstinence Best Practices: Five As plus referral to a quit line Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date. |
| FG002 | Best Practices, Financial Incentives, and NRT | Participants will receive the Five As, a referral to a quit line, financial incentives contingent on biochemically confirmed smoking abstinence, and nicotine replacement therapy (NRT) provided in the form of both nicotine patches and gum/lozenge for dual therapy. Best Practices: Five As plus referral to a quit line Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date. Nicotine Replacement Therapy: Nicotine patches and gum/lozenge provided together for dual therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Best Practices | Participants will receive the Five As plus a referral to a quit line. Best Practices: Five As plus referral to a quit line |
| BG001 | Best Practices and Financial Incentives |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 7-day Point Prevalence Smoking Abstinence Levels | Point prevalence abstinence will be defined as self-report of no smoking in the past 7 days, not even a puff, with biochemical verification via breath carbon monoxide (CO) and urine cotinine. Abstinence at the 12-week (end of treatment) and 24-week assessment will be compared between the three treatment arms. | Posted | Count of Participants | Participants | Collected once per woman at approximately 12- and 24- weeks following quit date in each of the three smoking arms |
|
Adverse event data were collected across 48 weeks following study entry for each participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Best Practices | Participants will receive the Five As plus a referral to a quit line. Best Practices: Five As plus referral to a quit line |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious Adverse event | Gastrointestinal disorders | Non-systematic Assessment | Participant obtained transdermal nicotine replacement therapy from her primary care physician. She used greater than recommended dose of transdermal nicotine plus an e-cigarette resulting in gastric upset and treatment in Emergency Department. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen T. Higgins, PhD., P.I. | University of Vermont | 802-656-9615 | stephen.higgins@uvm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 21, 2020 | Jul 7, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 1, 2023 | Apr 21, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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|
| Financial Incentives | Behavioral | Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date. |
|
|
| Nicotine Replacement Therapy | Drug | Nicotine patches and gum/lozenge provided together for dual therapy |
|
|
| 7-day Point Prevalence Abstinence at 48-week Follow-up Assessment | Point prevalence abstinence will be defined as self-report of no smoking in the past 7 days, not even a puff, with biochemical verification via breath CO and urine cotinine. We will use this data to estimate relapse rates across treatment arms and for use in comparing SHSe levels in children of abstainers versus smokers. | 48 weeks following quit date |
| Smoking Abstinence | Biochemically-verified 7-day point-prevalence smoking abstinence. | Assessed once per woman at 6-, 12-, 24-, and 48-weeks following quit date. |
| Smoking Abstinence | Biochemically-verified 7-day point-prevalence smoking abstinence. | Collected once per woman at baseline, 6-, 12-, 24-, and 48-weeks following quit date. |
Number of inpatient child visits will be compared between the three treatment arms and between abstainers versus smokers, independent of treatment condition. |
| 48 weeks following quit date. |
| Number of Times Child Received Prescription Medications. | Number of times child received prescription medications will be compared between the three treatment arms and between abstainers versus smokers, independent of treatment condition. | 48 weeks following quit date. |
| Cost-effectiveness Analysis | Cost-effectiveness will include the cost of each intervention, measured by the Brief Drug Abuse Treatment Cost Analysis Program (Brief-DATCAP) and the economic cost of treatment (fixed costs based upon proportion of time and/or space utilized by the program). Estimated treatment costs will be combined with estimated child healthcare utilization costs to represent total costs per treatment condition. Treatment costs will be compared across the three treatment arms. | Study entry through 48 weeks following quit date. |
Participants will receive the Five As, a referral to a quit line, and financial incentives contingent on biochemically confirmed smoking abstinence
Best Practices: Five As plus referral to a quit line
Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date.
| BG002 | Best Practices, Financial Incentives, and NRT | Participants will receive the Five As, a referral to a quit line, financial incentives contingent on biochemically confirmed smoking abstinence, and nicotine replacement therapy (NRT) provided in the form of both nicotine patches and gum/lozenge for dual therapy. Best Practices: Five As plus referral to a quit line Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date. Nicotine Replacement Therapy: Nicotine patches and gum/lozenge provided together for dual therapy |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Maternal smoking status | Count of Participants | Participants |
|
Participants will receive the Five As, a referral to a quit line, and financial incentives contingent on biochemically confirmed smoking abstinence
Best Practices: Five As plus referral to a quit line
Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date.
| OG002 | Best Practices, Financial Incentives, and NRT | Participants will receive the Five As, a referral to a quit line, financial incentives contingent on biochemically confirmed smoking abstinence, and nicotine replacement therapy (NRT) provided in the form of both nicotine patches and gum/lozenge for dual therapy. Best Practices: Five As plus referral to a quit line Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date. Nicotine Replacement Therapy: Nicotine patches and gum/lozenge provided together for dual therapy |
|
|
|
| Primary | Objective Measure of Child Secondhand Smoke Exposure (SHSe) | SHSe will be defined as the level of cotinine measured in the urine of the youngest child at baseline, 6-, 12-, and 24-weeks following the mother's quit date. SHSe outcomes will be compared between the three treatment arms and between children of abstainers versus smokers independent of treatment condition. We hypothesize being able to detect greater reductions from baseline levels in the incentives compared to Best Practices treatment conditions and among abstainers compared to smokers. We report main effects of treatment condition as geometric means (+/- SEM) collapsed across the three assessment times for each treatment condition controlling for baseline values. | This analysis is based on only children who submitted a baseline and at least one valid urine specimen between Weeks 6-24. Note that numbers in the Overall Participant Flow pertains to mothers while those shown in this section pertain to children. | Posted | Geometric Least Squares Mean | Standard Error | ng/ml | Collected twice per child at baseline, and once at approximately 6-, 12- and 24-weeks following quit date |
|
|
|
|
| Secondary | Continuous Abstinence | Continuous abstinence will be defined as self-report of no smoking in the past 7 days at each time point, not even a puff, with biochemical verification via breath CO and urine cotinine. Continuous abstinence from quit date through 24 week assessment will be compared between the three treatment arms. | Posted | Count of Participants | Participants | 24 weeks following quit date |
|
|
|
|
| Secondary | 7-day Point Prevalence Abstinence at 48-week Follow-up Assessment | Point prevalence abstinence will be defined as self-report of no smoking in the past 7 days, not even a puff, with biochemical verification via breath CO and urine cotinine. We will use this data to estimate relapse rates across treatment arms and for use in comparing SHSe levels in children of abstainers versus smokers. | Posted | Count of Participants | Participants | 48 weeks following quit date |
|
|
|
|
| Secondary | Smoking Abstinence | Biochemically-verified 7-day point-prevalence smoking abstinence. | Participants who completed a valid baseline delay-discounting assessment. Six participants did not have a valid assessment making total N 192 rather than 198 participants. Analyses tested for interactions of treatment and delay discounting. If there is a significant interaction (P < 0.05) of treatment condition and baseline delay discounting, we report results separately by treatment condition. In the absence of significant interactions, we collapse results across treatment conditions. | Posted | Count of Participants | Participants | Assessed once per woman at 6-, 12-, 24-, and 48-weeks following quit date. |
|
|
|
|
| Secondary | Smoking Abstinence | Biochemically-verified 7-day point-prevalence smoking abstinence. | Participants who completed a valid baseline Cigarette-Purchase-Task (CPT) assessment. Ten participants did not have a valid assessment making total N 188 rather than 198 participants. Analyses tested for interactions of treatment and CPT Latent Factors. If there is a significant interaction (P < 0.05) of treatment condition and CPT Latent Factors, we report results separately by treatment condition. In the absence of significant interactions, we collapse results across treatment conditions. | Posted | Count of Participants | Participants | Collected once per woman at baseline, 6-, 12-, 24-, and 48-weeks following quit date. |
|
|
|
|
| Other Pre-specified | Number of Outpatient Child Visits to Healthcare Center. | Number of outpatient child visits will be compared between the three treatment arms and between abstainers versus smokers, independent of treatment condition. | Data collection on this outcome was to occur following completion of data collection on treatment outcomes. The COVID pandemic prevented data collection on this outcome. | Posted | 48 weeks following quit date. |
|
|
| Other Pre-specified | Number of Inpatient Child Visits to Healthcare Center. | Number of inpatient child visits will be compared between the three treatment arms and between abstainers versus smokers, independent of treatment condition. | Data collection on this outcome was to occur following completion of data collection on treatment outcomes. The COVID pandemic prevented data collection on this outcome. | Posted | 48 weeks following quit date. |
|
|
| Other Pre-specified | Number of Times Child Received Prescription Medications. | Number of times child received prescription medications will be compared between the three treatment arms and between abstainers versus smokers, independent of treatment condition. | Data collection on this outcome was to occur following completion of data collection on treatment outcomes. The COVID pandemic prevented data collection on this outcome. | Posted | 48 weeks following quit date. |
|
|
| Other Pre-specified | Cost-effectiveness Analysis | Cost-effectiveness will include the cost of each intervention, measured by the Brief Drug Abuse Treatment Cost Analysis Program (Brief-DATCAP) and the economic cost of treatment (fixed costs based upon proportion of time and/or space utilized by the program). Estimated treatment costs will be combined with estimated child healthcare utilization costs to represent total costs per treatment condition. Treatment costs will be compared across the three treatment arms. | Cost-effectiveness analysis was not conducted because data collection on necessary outcomes was not completed due to the COVID pandemic. | Posted | Study entry through 48 weeks following quit date. |
|
|
| 0 |
| 68 |
| 0 |
| 68 |
| 0 |
| 68 |
| EG001 | Best Practices and Financial Incentives | Participants will receive the Five As, a referral to a quit line, and financial incentives contingent on biochemically confirmed smoking abstinence Best Practices: Five As plus referral to a quit line Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date. | 0 | 63 | 1 | 63 | 0 | 63 |
| EG002 | Best Practices, Financial Incentives, and NRT | Participants will receive the Five As, a referral to a quit line, financial incentives contingent on biochemically confirmed smoking abstinence, and nicotine replacement therapy (NRT) provided in the form of both nicotine patches and gum/lozenge for dual therapy. Best Practices: Five As plus referral to a quit line Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date. Nicotine Replacement Therapy: Nicotine patches and gum/lozenge provided together for dual therapy | 0 | 67 | 0 | 67 | 0 | 67 |
|
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| D017530 | Health Care Quality, Access, and Evaluation |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| Mixed Models Analysis |
| 0.108 |
| Mean Difference (Final Values) |
| -0.597 |
| Standard Error of the Mean |
| 0.369 |
| 2-Sided |
| Superiority |
| Analysis tested for significant main effect of treatment condition on Child Urine Cotinine | Mixed Models Analysis | 0.007 | Mean Difference (Final Values) | -0.987 | Standard Error of the Mean | 0.361 | 2-Sided | Superiority |
| Analysis tested for significant main effect of time on Child Urine Cotinine | Mixed Models Analysis | 0.878 | Superiority |
Analysis tested for significant main effect of treatment condition on continuous abstinence at 24 weeks following quit date
| Chi-squared |
Degrees of freedom = 1 |
| 0.038 |
| Chi-Square Test Statistic |
| 4.287 |
| 2-Sided |
| Superiority |
| Analysis tested for significant main effect of treatment condition on continuous abstinence at 24 weeks following quit date | Chi-squared | Degrees of freedom = 1 | 0.531 | Chi-Square Test Statistic | 0.392 | 2-Sided | Superiority |
| Title | Measurements |
|---|---|
|
| # abstinent 48-wks |
|
| Regression, Logistic |
| 0.10 |
| Wald Chi-Square Test Statistic |
| 2.70 |
| 2-Sided |
| Superiority |
| Analysis tested for significant main effect of baseline temporal discounting on point-prevalence abstinence at 24-weeks following quit date adjusting for treatment condition. | Regression, Logistic | 0.074 | Wald Chi-Square Test Statistic | 3.202 | 2-Sided | Superiority |
| Analysis tested for significant main effect of baseline temporal discounting on point-prevalence abstinence at 48-weeks following quit date adjusting for treatment condition. | Regression, Logistic | 0.484 | Wald Chi-Square Test Statistic | 0.491 | 2-Sided | Superiority |
| Title | Measurements |
|---|---|
|
| # abstinent 48-wks |
|
| Regression, Logistic |
| 0.375 |
| Wald Chi-Square Test Statistic |
| 0.788 |
| 2-Sided |
| Superiority |
| The analysis tested for significant association between baseline price sensitivity (latent factor Amplitude) and abstinence at 24-weeks following quit date | Regression, Logistic | 0.777 | Wald Chi-Square Test Statistic | 0.080 | 2-Sided | Superiority |
| The analysis tested for significant association between baseline price sensitivity (latent factor Amplitude) and abstinence at 48-weeks following quit date | Regression, Logistic | 0.937 | Wald Chi-Square Test Statistic | 0.006 | 2-Sided | Superiority |
| The analysis tested for significant association between baseline price sensitivity (latent factor Persistence) and abstinence at 6-weeks following quit date | Regression, Logistic | 0.678 | Wald Chi-Square Test Statistic | 0.172 | 2-Sided | Superiority |
| The analysis tested for significant interaction between baseline price sensitivity (latent factor Persistence) and treatment condition for 6-week abstinence outcome | Regression, Logistic | 0.018 | Wald Chi-Square Test Statistic | 7.99 | 2-Sided | Superiority |
| The analysis tested for significant association between baseline price sensitivity (latent factor Persistence) and abstinence at 12-weeks following quit date | Regression, Logistic | 0.674 | Wald Chi-Square Test Statistic | 0.177 | 2-Sided | Superiority |
| The analysis tested for significant association between baseline price sensitivity (latent factor Persistence) and abstinence at 24-weeks following quit date | Regression, Logistic | 0.422 | Wald Chi-Square Test Statistic | 0.646 | 2-Sided | Superiority |
| The analysis tested for significant association between baseline price sensitivity (latent factor Persistence) and abstinence at 48-weeks following quit date | Regression, Logistic | 0.846 | Wald Chi-Square Test Statistic | 0.038 | 2-Sided | Superiority |