Clinical trial NCT02602288
Conditions: Second Hand Tobacco Smoke Nicotine Dependence
Sponsor: Temple University
Start date: 2016-02-01; Completion date: 2019-10-23
Enrollment: 396 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this randomized controlled trial is to develop and test the efficacy of a multilevel, multimodal intervention designed to modify maternal smoking behavior to reduce children's exposure to secondhand tobacco smoke (primary outcome) and promote their smoking cessation (secondary outcome). Low-income mothers who smoke will be enrolled. Mothers will be recruited from the supplemental nutrition program, Women, Infants and Children (WIC) clinics. All mothers visiting WIC clinics will receive a clinic-level intervention, which consists of nutrition counselors following an "ask, advise, and refer" protocol to identify if their children are exposed to secondhand tobacco smoke, advise mothers who smoke about the harms of such exposure and the benefits of reducing exposure, and referring mothers to the trial. Screened eligible mothers will be consented and randomized to an attention control condition focused on nutrition (CTL) or to an experimental (EXP) multimodal behavioral intervention that integrates telebased counseling to promote the reduction of child secondhand smoke exposure (SHSE) and maternal smoking with an adjunct smoking cessation mobile app and nicotine replacement therapy use. The investigators will test the primary hypothesis that relative to children in the CTL condition, those in the EXP condition will have lower exposure SHSE as measured by mothers' reports and child cotinine levels. The investigators will also test the secondary hypothesis that relative to mothers in the CTL condition, those in the EXP condition will have higher bioverified 7-day point prevalence quit rates. In addition, the study will: (a) evaluate if specific psychosocial and behavioral factors-- social support, urge coping skills, self-efficacy, and SHSe protective behaviors--mediate the effects of the EXP intervention on outcomes and (b) explore whether other residential smokers, level of nicotine dependence, depressive/anxious symptoms, weight concerns, intervention dosage, and pregnancy status predict outcomes and moderate treatment effects.

Detailed description:

Arms: arm 1: Ask Advise Refer (AAR): WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources. Telebased tobacco counseling: Telephone counseling to promote parent's smoking cessation and behaviors to protect children from secondhand tobacco smoke. Mobile phone smoking cessation application: Smartphone based application to support smoking cessation efforts. Nicotine polacrilex: Over the counter nicotine replacement therapy in gum or lozenge form. arm 2: Ask Advise Refer (AAR): WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources. Telebased nutrition counseling: Telephone counseling to promote nutritious eating practices in the family. Mobile phone nutrition application: Smartphone based application to support healthy eating habits
Interventions: intervention 1: Ask, Advise, Refer intervention 2: Telebased tobacco counseling intervention 3: Telebased nutrition counseling intervention 4: Mobile phone smoking cessation application intervention 5: Mobile phone nutrition application intervention 6: Nicotine polacrilex
Intervention descriptions: intervention 1: WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources intervention 2: Telephone counseling to promote parent's smoking cessation and behaviors to protect children from secondhand tobacco smoke intervention 3: Telephone counseling to promote nutritious eating practices in the family. intervention 4: Smartphone based application to support smoking cessation efforts intervention 5: Smartphone based application to support healthy eating habits intervention 6: Over the counter nicotine replacement therapy in gum or lozenge form.

Protocol documents:
Prot_SAP_ICF_000.pdf: 
Cover page:  Study protocol and statistical analysis plan and consent form 
 
Title Babies Living Safe and Smokefree (BLiSS) 
 
NCT Number: NCT02602288 
 
Document date 12/15/2015 


Permission to Take Part in a Human Research Study  
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Document Revision Date: August 28, 2021 
 
 
 
 
Title of research: Babies Living Safe and Smokefree (BLiSS) Program, IRB PROTOCOL 23188 
Investigator and Department: Bradley N. Collins, Ph.D., Department of Behavioral Sciences, and 
Stephen J. Lepore, Ph.D., Department of Behavioral Sciences 
Why am I being invited to take part in this research? 
We invite you to take part in a research study because you were referred by your WIC nutrition 
counselor, are above 18 years old, you currently smoke, and you have a child less than 6 years of age.  
What should I know about this research? 
• Someone will explain this research to you. 
• Whether or not you take part is up to you. 
• You can choose not to take part. 
• You can agree to take part and later change your mind. 
• Your decision will not be held against you. 
• You can ask all the questions you want before you decide. 
Who can I talk to about this research? 
If you have questions, concerns, or complaints, or think the research has hurt you, contact the research 
team at: 
Bradley N. Collins, Ph.D. 
 
 
 
Stephen J. Lepore, Ph.D. 
Department of Social & Behavioral Sciences 
Department of Social & Behavioral Sciences 
Ritter Annex, Room 965  
 
 
 
Ritter Annex, Room 965 
1301 Cecil B. Moore Ave 
 
 
 
1301 Cecil B. Moore Ave 
Phila PA 19122-6091  
 
 
 
Phila PA 19122-6091 
(215) 204-2849 
 
 
 
 
(215) 204-9422   
collinsb@temple.edu  
 
 
 
slepore@temple.edu 
This research has been reviewed and approved by an Institutional Review Board. You may talk to 
them at (215) 707-3390 or e-mail them at: irb@temple.edu for any of the following: 
• Your questions, concerns, or complaints are not being answered by the research team. 
• You cannot reach the research team. 
• You want to talk to someone besides the research team. 
• You have questions about your rights as a research subject. 
• You want to get information or provide input about this research. 
Why is this research being done? 
This health counseling study is a partnership between the Philadelphia WIC program and behavioral 
health staff at Temple University. The goal of the study is to help improve your family’s health.  
Temple IRB Approved 
12/15/2015 


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Document Revision Date: August 28, 2021 
 
How long will I be in this research? 
We expect that you will be in this research for 1 year.  
How many people will be studied? 
We expect about 370 people will take part in the research.  
What happens if I agree to be in this research? 
Your participation will include the following: 
1. You will be assigned to one of two groups: a group that focuses on reducing your children’s 
exposure to tobacco smoke OR a group that focuses on improving your family’s nutrition on a 
budget. The group you are assigned to will be chosen by chance, like flipping a coin. Neither 
you nor the study doctor will choose what treatment you get. You will have an equal chance of 
being in either group. Please consider whether you are open to being assigned to EITHER 
group. 
2. You will complete three 30-minute phone interviews, and three brief in-home visits. These are 
scheduled at Week 1, after you finish health counseling (week 12), and 1 year after you start 
the program. 
a. These interviews will ask you to report information about your background, advice 
from your WIC counselor, and your health behavior, for example, your smoking.  
b. At the home visits, we will ask you health-related questions, and you will collect a 
sample of urine from your child. We will schedule these brief home meetings at a time 
that is convenient for you. The urine samples are used to only check for the amount of 
cotinine in your child’s urine.  Cotinine is a chemical that gets into children's bodies if 
they breathe tobacco smoke.  
c. If you report having quit smoking during your 2nd and 3rd home visits, we will collect 
a saliva sample from you to only test for cotinine. This cotinine test will verify your quit 
status.  
d. Your answers to these questions will be kept confidential. No one outside the study 
team will have access to your information, including your WIC counselor. You may 
refuse to answer any questions that you are not comfortable answering.  
3. During this program, you will also complete up to five 15-30 minute phone calls with a health 
counselor over the course of approximately 8-weeks. During these meetings, you will work 
with your counselor to set your family’s nutrition goals or goals related to protecting your 
children from tobacco smoke, depending on the group to which you are assigned. Your health 
counselor will provide you with coaching and support to help you reach your goals. You will 
also receive informational materials as a resource during your time in the program. 
4. As part of the health counseling program, you will also download a mobile health app that will 
supplement the advice and support from your coach. Our staff will provide an overview of the 
app in your first home visit. Also, your coach may send you text messages or prompts through 
your app asking you to complete questions that will help you track your progress. 
5. If you are randomly assigned to the group that focuses on reducing your children’s exposure to 
tobacco smoke, you will receive up to an eight week supply of nicotine gum or nicotine 
lozenges. 


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Document Revision Date: August 28, 2021 
 
What other choices do I have besides taking part in this research? 
Instead of being in this research, your choices may include calling the Pennsylvania state Quitline for 
smoking counseling services or using the healthy eating services provided to you at WIC.  
What happens if I agree to be in this research, but I change my mind later? 
Your decision to enter this research study is voluntary, and you are not required to stay in the program.  
You are free to withdraw from this study at any time. Non-participation in the research or withdrawal 
from the study will not prejudice your future interactions with the investigator or Temple University. If 
you stop being in this research, already collected data may not be removed from the research database; 
however, no further information will be collected from you for research purposes. Your decision to not 
participate or discontinue participation will not affect the services you receive from WIC. 
Is there any way being in this research could be bad for me? 
There are no known risks associated with the counseling materials used in this study.  In very rare 
cases, you may get upset when you hear about some health risks, such as smoking. If you do become 
upset, we will work with you and try to help you with any concerns. If you do quit smoking you may 
experience nicotine withdrawal. Symptoms of withdrawal include headache, nausea, change in mood, 
change in appetite, fatigue or insomnia. The risks associated with taking over-the-counter nicotine 
polacrilex (another word for nicotine gum or lozenges) include mouth problems, sore throat, 
indigestion, irregular heartbeat or, more rarely, nausea, vomiting, dizziness, diarrhea, weakness or 
rapid heartbeat.  
There is minimal economic burden to you. All surveys and health counseling take place on the phone 
which could use up some of your phone minutes. There is a possibility you could be charged for use of 
the smartphone app affiliated with the study. Study payments are designed to cover the cost of phone 
minutes and data usage. 
Those assigned to one group may not see improved smoking habits or secondhand smoke exposure 
compared to the other group. 
Will being in this research help me in any way? 
We cannot promise any benefits to you or others from taking part in this research. However, as 
participants in this study, you will receive advice, support, written materials, and counseling that may 
help you improve your health and the health of your child and family and begin healthier lifestyles. 
What happens to the information collected for this research? 
To the extent allowed by law, we limit the viewing of your personal information to people who have to 
review it. We cannot promise complete secrecy. The IRB, Temple University, North Inc., National 
Cancer Institute, the Food and Drug Administration and its affiliates may inspect and copy your 
information.   
Although the study team has placed safeguards to maintain the confidentiality of your personal 
information, there is always a potential risk of an unpermitted disclosure. To reduce that risk, all 
documents and information pertaining to this research study will be kept confidential, unless required 
by applicable federal, state, and local laws and regulations to be disclosed.  The results of this study 
may be published.  If any data are published, you will not be identified by name. 


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Document Revision Date: August 28, 2021 
 
You will also need to sign a separate “Authorization to use and disclose your protected health 
information” to be a part of this research. The only protected health information we collect is name, 
date of birth, address, phone number, your child’s date of birth and, if you choose to share it, your 
email address. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by 
U.S. Law. This website will not include information that can identify you. At most, the website will 
include a summary of the results. You can search this website at any time. Federal law provides 
additional protections of your personal information. These are described in another document titled 
“Authorization to use and disclose your protected health information” which you will receive at the 
first home visit 
Can I be removed from this research without my OK? 
The person in charge of this research or the sponsor can remove you from this research without your 
approval. Possible reasons for removal include no longer living with the child that is providing the 
urine sample, moving out of state, or exhibiting behavior that causes concern for staff safety. You may 
no longer be able to continue in the program if you do not complete an interview or if you do not 
provide cotinine (urine or saliva) samples. 
What will I be paid for taking part in this research? 
If you agree to take part in this research, we will pay you up to $225 for your time and effort. 
Specifically $100 at the beginning of the study, up to $75 at the end of treatment, and up to $50 at the 
end of your participation. Federal tax law requires to you to report this payment as income to the 
Internal Revenue Service. You may be asked to tell us your social security number. If payments are 
more than $599.00, we will report them to the Internal Revenue Service and send you a Form 1099-
MISC. If you do not give us your social security number, you may take part in this research if you 
agree to not be paid. 
 
Do you have any questions? 


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Document Revision Date: August 28, 2021 
 
Signature Block for Adult Subject Capable of Consent 
Your signature documents your permission to take part in this research. 
 
 
 
Signature of subject 
 
Date 
 
 
Printed name of subject 
 
 
 
Signature of person obtaining consent 
 
Date 
 
 
 
Printed name of person obtaining consent 
 
 
 
 
 
 


Permission to Take Part in a Human Research Study  
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Document Revision Date: August 28, 2021 
 
 
Signature Block for Child Subject 
Your signature documents your permission for the child named below to take part in this research. 
 
 
Printed name of child 
 
 
 
Signature of parent or individual legally authorized to consent to 
the child’s general medical care 
 
Date 
 
 
Printed name of parent or individual legally authorized to 
consent to the child’s general medical care 
 
 
 
Signature of second parent  
 
Date 
 
 
Printed name of second parent 
 
If signature of second parent not obtained, indicate why: (select one) 
❑ The IRB determined that the permission of one parent is 
sufficient. 
❑ Second parent is deceased 
❑ Second parent is unknown  
❑ Second parent is incompetent 
❑ Second parent is not reasonably available 
❑ Only one parent has legal responsibility for the 
care and custody of the child 
 
 
 
Signature of person obtaining consent 
 
Date 
 
 
Signature of person obtaining consent 
 


 
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1) Abstract of the study 
 
Children’s secondhand smoke exposure (SHSe) remains a leading cause of avertible morbidity/ 
mortality, with links to asthma, otitis, SIDS, behavior problems and risk of cancer and cardiovascular 
disease. Addressing SHSe is a public health priority, particularly in low-income, young children–a group 
with excess tobacco-related risk and burden. Community clinics (e.g., Special Supplementary Nutrition 
Program for Women, Infants and Children [WIC]), can reach this population. WIC’s standard practice 
for addressing SHSe includes minimal self-help advice to parents, an approach with inadequate 
efficacy. Clinical practice guidelines (“AAR”) recommend that practitioners “Ask” parents about child 
SHSe, “Advise” them about harms, and “Refer” smokers to evidence-based treatments that address 
multiple determinants of smoking. Thus, we propose to test a multilevel, multimodal treatment model 
that combines a system-level WIC intervention following AAR guidelines with a more intensive, 
individual-level multimodal behavioral intervention (MBI) that integrates telephone SHSe reduction and 
cessation counseling with coaching on the National Cancer Institute’s (NCI’s) QuitPal mobile app and 
nicotine replacement therapy (NRT) use. We will train staff in Philadelphia WIC clinics to implement 
AAR with referrals to the trial. We will then randomize 372 eligible parents to receive AAR+MBI or 
AAR+CTL (attention control intervention [nutrition education]). All participants will receive AAR in WIC 
clinics because it is an easily adoptable, potential standard of care in community public health clinics. 
The primary aim is to test the hypothesis that AAR+MBI compared to AAR+CTL will result in greater 
reductions in child cotinine (SHSe biomarker) and reported cigarettes exposed/day at end of treatment 
(12 weeks) and 12-month follow-up. A secondary aim is to test the hypothesis that AAR+MBI vs. 
AAR+CTL will result in higher bioverified 7-day point prevalence quit rate among parents at 12-weeks 
(end of treatment) and 12-months. We will test the hypothesis that social support, urge coping skills, 
self-efficacy, and SHSe protective behaviors mediate effects of AAR+MBI on smoking outcomes and 
explore whether other factors moderate treatment effects.  
 
2) Protocol Title 
The protocol title is: Multilevel tobacco intervention in community clinics for underserved families. 
We will refer to the study as BLiSS: Babies Living Safe and Smokefree. 
 
3) Investigators 
Stephen J. Lepore Ph.D. and Bradley N. Collins Ph.D. 
 
4) Objectives 
 
We aim to implement and evaluate a multilevel, multimodal treatment model combining a system-level 
WIC clinic staff training to improve their operations involving referral practices for mothers who smoke 
(“Ask, Advise, & Refer” [AAR]) with an individual-level multimodal behavioral intervention (MBI) that 
integrates nicotine replacement therapy (NRT), an SHSe-protection and cessation quitline (with 
supplemental print materials for family), and a mobile application (NCI’s QuitPal).  
 
Aim 1: Test the hypothesis that our BLiSS program integrating a WIC system-level quality improvement 
staff training in AAR referral practices with an intensive individual-level MBI (AAR+MBI) will be more 
effective in reducing child SHSe (primary outcome) than a WIC AAR+attention control intervention 
(AAR+CTL). Hypothesis 1: Compared with control children, those in the AAR+MBI condition will have 
significantly greater reductions in SHSe, measured by child urine cotinine and parent-reported child 
daily SHSe (from all products and sources), from baseline to 12-week and 12-month follow-up.  
 
Aim 2: Test the hypothesis that AAR+MBI will be more effective at increasing quit rates (secondary 
outcome) than AAR+CTL. Hypothesis 2: Compared with the control group, mothers in the AAR+MBI 


 
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group will have a significantly greater cotinine-verified, 7-day point prevalence quit rate at 12-week and 
12-month follow-up. 
 
Aim 3: Test hypotheses that changes in theoretically important variables will mediate (and precede in 
time) the effects of AAR+MBI on child SHSe and parent smoking outcomes. Hypothesis 3: Compared 
with parents in the control condition, parents in the AAR+MBI condition will evidence greater increases 
in SHSe protective behaviors, social support, urge management coping skills, and self-efficacy related 
to protecting child from SHSe and quitting smoking from baseline to 12-week follow-up. In turn, these 
changes in mediator variables will account for between-group differences in SHSe and cessation 
outcomes at 12-month follow-up. 
 
Aim 4: Explore factors that may influence outcomes and moderate intervention effects, including 
presence of other smokers at home, nicotine dependence, depressive/anxious symptoms, pregnancy 
status, weight concerns, and intervention dosage (e.g., project quitline, NRT, and QuitPal usage).  
 
5) Background 
 
A systematic review1 identified key limitations in current approaches to address SHSe: few studies 
produce significant SHSe reductions or use bio-verified measures; unimodal and clinic-based 
interventions tend to be minimal, not tailored to individuals’ needs, and are generally ineffective. 
Our novel "high tech-warm touch" MBI approach tackles prior limitations by embedding AAR within 
WIC operations to increase low-income maternal smokers’ access to intensive evidence-based 
interventions. We use technology (via prompts in electronic records) to engage WIC staff in AAR 
and to enhance project quitline counseling (via client-specific coaching in QuitPal app). Provision of 
NRT paired with education about NRT use addresses gaps in NRT access and uptake in this 
population. By measuring implementation of MBI components (e.g., NRT, project quitline, QuitPal) 
and hypothesized mediating/moderating variables, and ascertaining outcomes by multiple methods, 
we can test the efficacy of and improve knowledge about integrated best practices for intervening 
with a high-risk population.  
 
6) Setting of the Human Research 
Referrals for this trial will come from up to 10 Philadelphia WIC clinics. During routine WIC visits, WIC 
Nutrition Professionals will implement the AAR protocol with mothers who smoke. Moms who are not 
currently pregnant, and say they are interested in BLiSS will fill out a referral sheet. BLiSS staff will pick 
up referral sheets weekly and return them to the Temple lab in Ritter Annex 965.  
Survey administration and health counseling is telephone-based. Participants will receive 3 home visits 
over the course of a year at baseline, end of treatment (12 weeks) and 12-month follow up. These visits 
facilitate delivery and overview of written intervention materials. They also allow staff to pick up the 
child’s urine sample from the parent. This sample is used for the sole purpose of assaying cotinine, a 
metabolite of nicotine that provides a biomarker of child exposure to SHS. 
The Data Safety and Monitoring Board will consist of two individuals, one with expertise in smoking 
and cessation treatments and another with expertise in smoking cessation intervention research and 
statistics. The role of the DSMB will be to review data regularly to monitor adherence to the data 
safety plan and potential adverse events from study participation. The Project Statistician will 
provide statistics on attrition and adverse events to the DSMB. The DSMB will review the annual 
statistics to determine whether there is a reason to change study procedures or terminate the study. 
Following any DSMB review, the DSMB will write a report outlining recommendations. These 


 
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recommendations will be forwarded to the Principal Investigators (Drs. Collins and Lepore) at 
Temple University and included in the annual progress report to the NIH sponsor. 
 
7) Resources Available to Conduct the Human Research 
North Inc. serves approximately 70,000 clients in the county of Philadelphia and reports that about 25% 
are smokers (~17,500). We propose a 5-year timeline: hiring and training (months 1-9); clinic 
implementation and training (months 1-9); enrollment and baseline assessments (months 9-42); 3- and 
12-month follow-up assessment (months 12-54); analyses and manuscripts (months 55-60).  
Facilities: 
Dr. Lepore’s lab comprises approximately 1600 square feet of dedicated lab and office space. This 
area includes two single offices for senior research staff and eight cubicles for other research staff. 
Staff members and research assistants have their own networked desktop computer, and access to 
printers, fax machines and copy machines. Dr. Collins’ lab includes approximately 2000 square feet 
of dedicated lab and office space. His staff and research assistants have adjacent office space with 
access to networked desktop computers, printers and a copy machine and fax. His lab includes a 
secure room used for biosample handling and storage, with a -80 degree freezer for storing 
biosamples, and large cabinets, racks and shelving for supply storage.  
Communication: 
All staff complete an extensive training checklist that includes background reading, viewing PowerPoint 
training modules, listening to recorded interviews from previous studies, role playing mock interviews, 
and observing on home visits. Staff are given feedback on role plays and a senior staff member will 
periodically sit in on interviews for quality assurance. Inadequate performance will result in repeated 
quality control checks until performance has improved. Dr. Collins will oversee supervision to staff 
conducting smoking counseling. He will also provide treatment fidelity checks on a portion of all 
counseling recordings. All staff will attend weekly staff meetings where project updates will be provided. 
8) Prior Approvals 
Our co-investigator, who is the executive director of North Inc. (manager of the Philadelphia WIC 
program, where we will be enrolling participants) has agreed to our working with WIC clients in up to 10 
clinics in Philadelphia. All BLiSS staff will obtain CITI certification in human subjects’ research. Staff 
handling biosamples will have completed and will remain current in Temple’s bloodborne pathogen and 
shipping of dangerous goods trainings so they can handle and ship urine and saliva samples. 
9) Study Design 
a) Recruitment Methods 
Subjects will be recruited during in-person visits to Philadelphia WIC clinics. WIC staff will be trained to 
follow the AAR protocol whenever they encountered a mom who smokes. Moms who say they are 
interested in BLiSS will fill out a hard copy referral sheet providing their name, age, phone number, and 
if they have a smartphone. BLiSS staff will pick up referral sheets 2-3x a week and return them to the 
Temple office. Temple staff will then contact clients who completed the referral form for eligibility 
screening. All forms will be shredded after screening. Eligible participants contact information will be 
stored in a secure database, separate from all other data to maintain confidentiality. The secure 
database is encrypted and password protected on a password protected computer in lab room 965 
Ritter Annex.   
Participants will be eligible to receive a total of up to $225 over the course of one year as compensation 
for time completing assessments. Payments will be made after each home visit. Payments vary to 
reflect the amount of time and effort put in by the participant. 


 
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b) Inclusion and Exclusion Criteria 
BLiSS staff will call WIC clients who fill out referral sheets and conduct a phone screening for eligibility. 
Inclusion criteria: We will recruit English-speaking mothers/female guardians (one per child) who are 
>17 years old, self-report smoking, own a smartphone, and have a child <6 years old who is exposed to 
tobacco smoke. We will use the youngest eligible child not in diapers for assessments, or the oldest 
child in diapers. We will include nursing mothers, but they will not receive nicotine replacement therapy 
(NRT) without written physician approval. Child cotinine from nursing mothers will not be analyzed 
because of confounding (cotinine transferred through breast milk). Exclusion criteria include pregnancy 
and presenting issues that can interfere with a person's ability to provide informed consent or follow 
and complete study procedures (active psychosis, inadequate health literacy, or (non-nicotine) drug 
dependence). We plan to enroll 372 subjects. We anticipate we’ll need about 3,700 referrals to reach 
our enrollment goal. 
c) Study Timelines 
 
Subjects agree to participate for one year. We propose a 5-year (60 month) timeline: formative 
evaluation, hiring and training (months 1-9); clinic implementation and training (months 1-9); enrollment 
and baseline assessments (months 9-42); end of treatment and 12-month follow-up assessment 
(months 12-54); analyses, presentations, and manuscripts (months 55-60).  
 
d) Study Endpoints 
 
Primary outcomes. (a) Child urine cotinine will be obtained by the parent using gloves and materials 
provided to them to prevent contamination of the sample. Assays use validated, sensitive, high 
performance liquid chromatography-tandem mass spectrometry with cotinine detection limit <0.01 
ng/mL urine and quantitation limit at 0.05 ng/mL. Cotinine remains the gold standard child secondhand 
smoke exposure (SHSe) assessment. (b) Parent-report of child's SHSe in terms of cigarettes per day 
(and other products affecting SHSe, such as cigars, e-cigarettes, pipes) in the home, car, and away 
from home by all sources will be assessed for the 7 days prior to assessment.  
 
Secondary outcome. Parent-reported cotinine-verified 7-day point prevalence abstinence will be 
obtained using timeline follow-back methods incorporating a calendar to identify days abstinent since 
the last phone interview. During the 12-week and 12-month follow-up home visits, participants who 
report smoking abstinence will provide a saliva sample for validation using NicAlert cotinine test strips. 
Expired carbon monoxide readings will be taken as a backup to NicAlert to bioverify smoking 
abstinence in participants using NRT. 
 
e) Procedures Involved in the Human Research 
 
We will use a randomized, two-group design (AAR+MBI vs. AAR+CTL) with 3 measurement 
periods: pre-intervention, 12-weeks and 12-month follow-up. Follow-up periods follow standards in 
the field for short- and long-term follow-ups. We will recruit 1 smoker per household with a child < 6 
years old from WIC clinics, where we train WIC nutrition counselors in the AAR protocol: ask about 
child SHSe, give print self-help SHSe and cessation resources, and refer to project staff for 
eligibility screening. After AAR, smokers randomized to AAR+MBI will receive the multilevel, 
multimodal behavioral intervention (MBI) consisting of QuitPal app, a starter supply of nicotine 
polacrilex also known as nicotine replacement therapy (NRT) gum or lozenge, educational materials 
(print, videos), text messages, and project quitline counseling. The attention control group 
(AAR+CTL) will receive equivalent attention through a multimodal nutrition intervention consisting of 
a mobile app, educational materials, text messages, and phone counseling, but will not be given 
NRT or information on smoking treatments beyond the AAR level.  


 
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After receiving WIC referrals, project staff will conduct eligibility screens, consent, and baseline 
assessment via telephone, and then schedule a face-to-face session with intervention staff at a 
participant's home. Randomization occurs immediately prior to this meeting to maintain blinding of 
assessment staff. Separate assessment and counseling staff will be used to maintain blinding. 
Randomization will be stratified by clinic and presence of other smokers in the home using a 
permuted block design.  
 
Multilevel Behavioral Intervention (MBI) group. Staff will introduce the intervention to participants 
randomized to the AAR+MBI group by providing: (a) a research-ready QuitPal app with download 
assistance; (b) instruction in using QuitPal features; (c) enrollment in the project quitline; print 
materials; and (d) NRT starter and instructions.  
 
Modified QuitPal app: Apps continually need to be updated to work with different operating systems. 
The clinic formative evaluation phase will provide an opportunity to modify and test our research 
version of the NCI QuitPal for iPhone and Android users. The app will include project quitline 
number; entry of quit date and daily smoking log; tracking health progress; information about health 
improvements related to SHSe protection and cessation; motivating users through pushed 
messages providing support and positive reinforcement; links to motivational and informational 
audiovisual messages; urge tracking; pushed urge management suggestions; scheduled reminders; 
and goal progress summary. For this trial, QuitPal's Facebook feature is not included because the 
modified app is available only to research participants to enable usage pattern data collection and 
evaluation. Further, we will replace the app’s link to NCI’s QuitLine with a link to our project quitline.  
 
NRT starter and instructions: NRT products will be provided (nicotine polacrilex gum or lozenge). 
NRT is FDA approved for smoking cessation interventions and available over the counter. Following 
best-practice guidelines and practices implemented by state quitlines4,5, participants will be given a 
free 2-week supply of NRT and counseling to use it in conjunction with a quit day set at the 
treatment orientation. Participants will learn how to obtain additional NRT (i.e., advice on: [a] 
obtaining an NRT prescription if they are insured and do not have a primary care provider; and [b] 
Medicaid co-pays and reimbursement procedures). Following other quitline practices, uninsured 
participants will receive up to 8 weeks of NRT. Project quitline counselors will give advice on NRT 
use based on guidelines6,7 including benefits and harms, safe use and disposal. Free samples will 
only be provided to nursing mothers with written approval from a physician or other medical 
provider, and adverse side effects will be monitored during counseling and assessment.  
 
Telephone counseling: The timing and frequency of telephone sessions is guided by best practices, 
including multiple proactive calling4,9,10 and at least 2-3 completed calls4,11. We plan 5 proactive calls 
(unlimited client-initiated calls) to allow time to promote SHSe protections, to shape SHSe reduction 
achievements toward cessation, and provide the extra support for skills training and support that 
may be needed in our target population. Like other specialized quitlines12, we provide flexible call 
scheduling and send frequent reminder messages.  
 
Counselors will discuss participants’ QuitPal usage to support ongoing usage and to reinforce their 
individualized treatment plans. This will increase intersession intervention dosage around tailored 
counseling discussion points. For example, counselors may ask about use of specific, client 
relevant QuitPal tracking features (e.g., tracking cigarettes smoked per day) to integrate with 
tailored counseling (e.g., coaching self-monitoring as a strategy to facilitate urge management). 
 
The counseling model uses evidence-based motivational enhancement and Cognitive Behavioral 
Therapy (CBT) strategies for implementing telebased smoking interventions4,10,13,14. The telephone 


 
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counseling also is guided by recent evidence and approaches that use motivational components to 
promote family-level support for and adoption of SHSe protective behaviors among household 
members by capitalizing on parents’ desire to protect young children from SHSe. Key counseling 
components include: (a) increasing motivation for smoking behavior change with collaborative, 
individualized treatment plans, support with goal setting, and guidance for building social support; 
(b) addressing addiction with education and navigation for accessing and using NRT; (c) improving 
skills (e.g., self-monitoring) to identify smoking “triggers” and to manage smoking urges with 
compensatory CBT strategies; and (d) improving cessation self-efficacy. (This approach mirrors 
common evidence-based practices implemented in state and national quitline counseling models.)  
 
Counselor training: Our counselors have completed a 5-day program to become Certified Tobacco 
Treatment Specialists (CTTS) through U Penn’s Perelman School of Medicine (accredited by the 
Association for Treatment of Tobacco Use and Dependence). An additional 30 hours of counselor 
training by PIs will reinforce lessons learned in the CTTS program, but importantly, will also focus 
on (a) how to guide SHSe protection efforts as part of a CBT-framed strategy to shape parents’ 
behavior toward a cessation attempt, (b) how to facilitate SHSe protective behaviors and smoking 
behavior change in the context of challenges faced by low-income parents who smoke; and (c) how 
to drive a counseling process that integrates QuitPal mobile app usage to individualize the 
intervention to parents’ particular needs. Training in CBT strategies allows for tailoring counseling to 
participants based on identified barriers (e.g., other smokers in the home) and catalysts (e.g., 
concerns for child health) of behavior change. After intensive competency-based training, 
counselors will refine skills in ongoing weekly supervision that includes review of fidelity monitoring 
feedback, discussion of current cases, and role-playing of effective session interaction.  
 
Attention Control Intervention (CTL) Group. The purpose of the AAR+CTL group is to provide 
equivalent contact between the two conditions while providing distinctly different intervention 
content. Thus, the CTL session schedule will parallel the MBI condition. CTL health education 
content will focus on nutrition education. CTL clients will receive the commercially available, free 
mobile nutrition health app; access to Sesame Street’s “Food For Thought: Nutrition on a Budget” 
program on the web and in hard copy, and 5 calls related to family nutrition education.  
 
Measures 
Overview. Screening, consent, and baseline assessments are conducted after receipt of referrals 
from WIC offices. Participant self-report data at baseline, 12-week and 12-month follow-up will be 
collected via structured computer assisted telephone interviewing. This method reduces literacy 
barriers, minimizes participant burden, and maximizes data reliability. Collection of the child’s urine 
sample from the parent and parent biomarkers (Nicalert; CO readings) will take place during in-
person meetings with parents at home visits following baseline, end of treatment (12 week) and 12 
month phone assessments. Process data on QuitPal and project quitline usage will be collected in 
real time. Measures are tied to our theoretical model predicting reduction in child SHSe and parent 
smoking cessation.  
 
See 9d above for Primary and Secondary outcomes. 
 
Mediators. We identified several potential mediators: (a) Parental-reported exposure protection 
(PREP) behaviors are measured with self-report items used in our previous research and reflected 
in a recent meta-analysis. We operationalize PREP behavior in two measures: (1) families’ current 
home smoking policy (0=no restrictions to 4=total indoor ban); and (2) the sum of PREP behaviors 
(e.g., enforce smoking restrictions; avoid smoking in rooms where child eats and sleeps; move child 
away from others’ smoking).  (b) Support for SHSe protection and smoking cessation will be 
measured using a modified short form of the Partner Interaction Questionnaire. The modified 


 
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measure assesses perceived intervention staff support to participants for promoting smoke-free 
environments and cessation ( = .91). (c) Self efficacy of smoking behavior change will be 
measured. We will use the Smoking Cessation Self-Efficacy Scale, which assesses confidence in 
one’s ability to refrain from smoking in varied situations ( = .90), and a parallel form ( = .90) we 
developed for the KiSS trial to assess self-efficacy related to reducing child SHSe. (d) Coping with 
smoking urges will be assessed using the Urge Management Coping Skills measure developed for 
project KiSS. It captures how often smokers engaged in cognitive and behavioral coping strategies 
to manage smoking urges ( = .87). 
 
Covariates and moderators. We will test five variables as potential control variables and moderators 
of intervention effects. (a) Nicotine dependence will be measured with the reliable and validated 
Fagerström Test for Cigarette Dependence. (b) Depressive symptoms will be measured with the 
Center for Epidemiological Studies Depression Scale, which are validated, reliable and useful in 
smoking studies. (c) Weight concerns will be measured using a 6-item validated scale that 
measures general and smoking-specific weight concerns. (d) Pregnancy/postpartum status will be 
measured using a single, content valid item defined as: currently pregnant, postpartum (delivered 
youngest child within the last 12 months), or other (youngest child delivered >12 months ago). (e) 
Number of individuals who smoke cigarettes daily (or other products that affect SHSe) in the home, 
will be assessed using a standard, content valid item. Additional demographic and smoking history 
variables will be measured and assessed for possible association with outcomes.  
 
Process measures. Intervention processes will be assessed in both conditions at multiple time 
points, with multiple methods, and at each intervention level: AAR implementation, phone 
counseling, NRT utilization, and mobile app usage. Process data will include computerized tracking 
data from the QuitPal app, counselors’ observations, participant self-reports, and WIC nutrition 
counselor reports. QuitPal app process data will include frequency of launching and using (e.g., 
inputting data) features. Counselors' observations are recorded in “session reports” completed after 
each participant contact, including: (1) attendance; (2) duration; (3) ratings of participant 
engagement. Session report data can generate a measure of total contact time over the course of 
the intervention. Participant self-report measures will assess their receipt and use of, and 
satisfaction with, clinic, counseling, app, and NRT intervention materials and advice. Similar 
measures have been used in our ongoing studies evaluating the efficacy and feasibility of 
intervention components. 
 
f) Data Management  
Data analysis: 
The primary analyses will use an intention-to-treat approach. All randomized participants will be 
tracked in follow-up and missing outcome data will be addressed using multiple imputation 
methods. In sensitivity analyses, we will perform complete case analyses and we will also adapt the 
methods of Co-I Dr. Egleston to investigate the impact of data that is potentially missing not at 
random.  
Analyses for Aim 1: The primary outcome will be change in cotinine between (a) baseline and 3 
months and (b) baseline and 12 months. We will compare change scores between randomization 
arms using random-effects linear regressions in which we include randomization arm as a fixed 
effect and WIC clinic as a random intercept to account for potential clustering within clinic. We will 
assess the balance of potential confounding variables between randomization arms using linear or 


 
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logistic regressions with random intercepts to account for correlation within clinic. Potential 
confounders (e.g., nicotine dependence, depressive/anxious symptoms) will be added as covariates 
as necessary. We will also use multilevel random-effects regressions with random-effects to 
account for within subject correlation over time and within clinic correlation to investigate time trend 
trajectories. Panel time will be included in these longitudinal models. We will repeat analyses for 
self-reported child SHSe as a secondary outcome. We will also examine the per-protocol as-treated 
effect to explore dose-response relations. 
Analyses for Aim 2: We will use logistic regressions with random intercepts for clinic to compare 
bioverified self-reported quit status (yes/no) between randomization arms at 3 and 12 months. We 
will use multiple logistic regressions with random intercepts for clinic to control for potential 
confounding variables that were not balanced between randomization arms. Similar to analyses 
described in Aim 1, we will also examine random-effects longitudinal logistic regressions and per-
protocol as treated effects to explore dose-response relations. 
Analyses for Aim 3: To investigate mediation pathways, we will use a structural equation approach 
that is firmly rooted in the statistical field of causal inference. Outcomes include change in SHSe 
and parent quit status. We will include appropriate random-effects terms to account for correlated 
data within clinic and participant over time. We will use cluster-adjusted bootstrap standard errors 
for assessment of the mediated effect. In assessment of the mediated effect, we will ensure that the 
intervention is associated with the potential mediators and that the mediators are associated with 
the outcomes. We will examine mediation pathways in which the variables are measured in a 
temporal ordering consistent with a causal pathway. For example, we are primarily interested in 
pathways in which mediators of the intervention are measured at 12 weeks end of treatment and 
then outcomes are measured at month 12.  
Analyses for Aim 4: For moderation analyses, we will use random-effects regressions of the change 
in cotinine levels (SHSe) and parent quit status. In the models for Aim 4, we will include a dummy 
variable for randomization arm, the potential moderator variable, and an interaction term between 
the two (i.e. dummy variable multiplied by moderator variable). To maintain power to detect 
moderation, we will explore moderators separately. We will also use multiple regression models in 
which we include potential confounding variables, as well as the main effects and interaction terms 
of interest. 
Power Analysis: We chose our sample size so that we would have at least 85% power to detect 
between-group differences in the primary outcomes (3- and 12-month child cotinine). Using an 
estimate of 20% 1-year follow-up attrition based on the KiSS trial, we expect to have 298 
participants at 12 months (372*80% retention=298, or 149 per group). With 149 participants per 
group, we will have 85.7% power to detect an effect of 0.23 in the log cotinine change scores 
between randomization arms. We based the calculation on our previous counseling intervention 
data (mean log cotinine of 1.17 in intervention group, sd=0.58, and 1.40 in control group, sd=0.60). 
This also assumes a Type I error rate of 2.5% (2-sided) and the use of a random effects model in 
which the within clinic correlation is 0. We chose a Type I error rate of 2.5% using a Bonferroni 
correction for a familywise Type I error rate of 5% (0.05/2=0.025) to accommodate the two primary 
hypothesis tests (cotinine change at 3 and 12 months). We used R (R Software, Vienna, Austria) 
and PASS 11 (NCSS Software, Kaysville, UT) for calculations. 
Data Security: There are two primary types of data: parent interview responses and cotinine 
measures obtained by parent-collected samples. Interview data will be entered on a secured 
computer at Temple University in Dr. Lepore’s lab. A study identification number will be used to label 


 
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and track participants’ data. Most interview responses will be numerical responses to multiple-
response questions or rating scales. Cotinine data also will be tracked using a study identification 
number. Identifiers linking data to the identity of research participants will be maintained in a 
separate and secure area from other data. Files containing identifiers are stored in a locked cabinet in 
Ritter Annex Room 975. Files containing data but no identifiable information are stored in a locked 
cabinet in Ritter Annex Room 965. Temple study personnel have access to all paper files. The 
information collected in this study also will be recorded in computer files in such a manner that 
personal identifiers will be removed. Those computer files are encrypted and password protected 
and stored on a password protected computer. Such identifiers linking data to subjects will be 
maintained in a separate and secure area (computer in 965 Ritter Annex). At the end of the trial, all 
identifying information will be destroyed. 
Additional data collected from the QuitPal app are transferred automatically by the mobile 
app from each participant’s phone. The data are sent to a server via HTTPS. The data 
collected include statistical information about smoking habits, urges to smoke, coping 
mechanisms, and aggregate statistics such as frequency of application feature usage. The 
data collected from the mobile application do not include any personally identifying 
information. On the server, participants are identified only by an assigned participant ID 
number, which is known only to the research team. Database backups are performed 
regularly and are stored offsite. The encrypted data copy is performed via SSH and the 
backups are not accessed except in emergency.  An individual's data will be securely 
erased 6 months after she has completed participation in the study. 
Quality Control: Drs. Collins and Lepore will be responsible for overall treatment quality assurance. 
We will assess treatment fidelity of AAR across WIC clinics, the mobile app, and implementation of 
phone counseling components in experimental and control arms. Clinic-level AAR intervention 
fidelity will be assessed at various time points and with multiple methods. Project quitline counseling 
intervention fidelity will be assessed throughout the trial. Counselors will keep intervention 
component checklists to ensure consistent delivery of treatment components for each session in both 
arms. Sessions will be recorded; the project director will review checklists and a random 20% of tapes 
weekly against the intervention checklist. The expectation is to maintain >90% fidelity. 
Storage of Specimens: Dr. Collins’ lab includes a locked room used for biosample handling and 
storage, with a -80 degree freezer for storing urine and saliva biosamples. Samples are labeled with 
participant ID numbers, date, and study timepoint. Only staff who have completed Temple’s 
bloodborne pathogens training are permitted to access the samples. Periodic UPS shipment of 
samples to a lab that conducts assays follows Temple’s Environmental Health and Radiation Safety 
protocols. 
g) Confidentiality 
See item 12 below. 
h) Provisions to Monitor the Data to Ensure the Safety of subjects 
The Data Safety and Monitoring Board will consist of two individuals with expertise in smoking and 
cessation treatments and statistics. The DSMB will review data regularly to monitor adherence to the 
data safety plan and potential adverse events from study participation. The Project Statistician will 
provide statistics on attrition and adverse events. The DSMB will review the annual statistics to 
determine whether there is a reason to change study procedures or terminate the study. Following 
any DSMB review, the DSMB Chair will work with other board members to write a report outlining 


 
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recommendations. These recommendations will be forwarded to the Principal Investigators (Drs. 
Collins and Lepore) at Temple University and included in the annual progress report to the NIH 
sponsor. 
 
i) Withdrawal of Subjects 
Participants can be withdrawn from the research for three reasons: 
1) The participant no longer lives with the child that is providing the urine sample. In previous studies, 
this happened when a subject was incarcerated, became a resident of a recovery house, lost custody 
of their child, or moved somewhere the child did not reside. This prevents us from assessing our 
primary outcome, child exposure to secondhand smoke by the parent. 
2) The participant moves out of state.  
3) The participant exhibits behavior that causes concern for staff safety. This could include mental 
instability, making threats or behaving aggressively, making sexual overtures or any other behavior that 
staff deem to be unsafe. 
When a participant is withdrawn, they will be contacted by phone and receive an explanation. If staff 
are unable to reach them by phone, a letter will be sent. Participants will be paid any money due for 
study work they have already completed. 
When a participant informs the project team that they wish to withdraw from the study, this action will 
not prejudice future interactions with study staff, Temple University, or WIC as noted in the consent 
form. 
If a participant elects to discontinue participation in the study they will earn compensation for any 
completed assessments but will be informed that they are not eligible for future incentives related to the 
study but WIC services will not be affected. They will also be informed that they will not be contacted 
further. 
 
10) Risks to Subjects 
 
There are no known risks in using WIC nutrition counselor or telephone counselor advice and 
support for child SHSe reduction and parent smoking cessation. The advice provided by nutrition 
counselors follows nationally established guidelines for offering routine advice about the harms of 
smoking in clinic settings.15 The telephone counseling protocol follows routine messages and 
approaches that participants would be exposed to in any freely available state-sponsored telephone 
quitline for smoking. The mobile app that participants have access to is freely available and 
distributed by the National Cancer Institute on a publicly available website. Parents may refuse 
advice and referrals, but none of the key personnel in this trial are aware of cases where parents 
refused additional clinic services because of their reaction to smoking advice provided in clinic. 
There are no known risks associated with the educational materials or the counseling session 
materials and protocols or the assessment protocols used in this project or previous projects from 
which procedures, protocols, and content were modeled. In rare cases, side effects of the 
intervention may include emotional distress from hearing about risks from smoking to one's self or 
one's children; however, staff and counselors are trained to deliver health messages and advice in 
a supportive, empathic, normalizing, and problem-solving manner that minimizes the likelihood and 
degree of distress a parent might experience. For parents who quit smoking, individuals may 
experience temporary smoking cessation withdrawal symptoms (e.g., increased appetite, cravings). 
However, key components of both levels of treatment and the provision of patient navigation to 
maximize access and use of recommended over-the-counter NRT that attenuate withdrawal 


 
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symptoms, will help participants prepare for these potential symptoms and manage them 
successfully. Hence, as explicitly stated in the program materials, we will make every attempt to 
minimize potential distress and will work with participants to lower any distress that may occur.  
Subjects randomized to either group may not benefit better or at all compared to those 
randomized to the other group. 
The risks associated with taking over-the-counter nicotine polacrilex include mouth problems, sore 
throat, indigestion, irregular heartbeat or, more rarely and associated with nicotine overdose, nausea, 
vomiting, dizziness, diarrhea, weakness, or rapid heartbeat. We will educate participants about 
common side effects associated with NRT use and will monitor side effects at every counseling and 
assessment contact. We will review these risks with participants following published clinical practice 
guidelines and recommendation of the US Food & Drug Administration (e.g., we will only provide 
NRT samples to nursing women if they present written permission of their physician or prescription 
to use it). We will also include flyers for participants to place in their home (e.g., beside medicine 
cabinet) as a reminder of NRT instructions and numbers to call if they are concerned about side 
effects (their physician's office, quit line, our staff phone numbers.) NRT is FDA approved for over-
the-counter use and is routinely dispensed by city and state departments of public health and state-
sponsored smoking cessation quitlines.  
There are no identifiable risks to others who are not participants in this study. This includes 
participants’ children. 
We will make every attempt to minimize any potential risks. Exclusion criteria include self-reported 
major psychiatric disorders, thereby reducing the probability that the sample will present with 
problems or emergencies related to psychiatric disorder. However, even if parents have not received 
prior diagnoses of psychiatric disorders, there is a chance that they will present with symptoms of 
psychological distress (e.g., depressive or anxious symptoms, or stress). Such symptoms have 
been observed among nicotine-dependent individuals and those faced with ongoing burdens of 
socioeconomic and psychosocial strains of poverty and parenting young children. We plan to 
include the CESD to assess depressive symptoms at baseline, EOT, and follow-up. Participants 
who score in a range considered at risk for depression will be provided with referral information for 
free mental health services in their community. Program staff also will be trained to engage in a brief 
harm assessment interview that can be implemented at each subsequent contact with the participant 
in such cases. Likewise, all staff members who have contact with participants are trained in 
accordance with Temple University medical emergency protocols to ensure preparation of 
circumstances around emergent mood- or medical-related issues that could arise during telephone 
counseling sessions. Any time staff members are concerned about a clients’ disposition, or confront 
an actual emergency during a session, they will contact one of the Co-PIs; and if a PI is not 
immediately available, they will contact the Temple University Health System psychiatrist on call. As 
outlined in the emergency protocol, a Co-PI (or Temple University physician/psychiatrist) will then 
assess the parent by phone to determine if further steps are necessary. Emergencies have not 
occurred in the 14 years that the Dr. Collins has been working with this and similar populations in 
clinical trials. Nonetheless, the following emergency protocol is in place: 
 
(1) If a participant presents with potential depressed mood, anxiety symptoms, or distress, but 
expresses no intent to harm self or others, the PI will provide referral information and the phone 
number to the Temple University Health System’s (TUHS) Psychiatry Services. This clinic offers 
outpatient services on a sliding scale for non-insured patients including evaluations, psychotherapy, 
and psychopharmacology treatment for Bipolar and Psychotic Disorders, Major Depression, and 
Anxiety Disorders. The PI will also provide participants with the number of TUHS Psychiatric 
Emergency Services center (PES) in case they escalate following the phone call and feel they need 
emergency services. The PES provides emergency transport to the hospital and comprehensive 


 
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psychiatric evaluation, immediate intervention and stabilization, and referral services 24 hours a 
day, 7 days a week. The participant will be monitored closely for the rest of their enrollment and 
reminded of referral information at each contact. 
 
(2) If the PI assesses suicidal ideation or violence without a plan, the PI will follow the same steps as 
scenario “1". If the participant states they would feel safer under supervision, the PI will arrange for 
psychiatric evaluation or for an escort to the PES. He will follow-up with the patient the following day 
to ensure that either referral was followed through, and the participant will continue to be monitored 
as in “1”. 
 
(3) If the participant expresses ideation with intent to hurt him/herself or someone else, the PI will 
determine if a report should be sent to Protective Services in cases of suspected child abuse and/or 
arrange for escort to the PES. If an escort is necessary, the PI will follow-up with the participant the 
next day to ensure adherence to the referral and recommendations. They will continue to be 
monitored as in “1”. 
 
(4) If a medical, non-psychiatric emergency arises during a counseling session or 
interview/assessment, staff will call 911 on behalf of the family to ensure that proper medical 
attention is received. 
 
11) Potential Benefits to Subjects 
 
Direct benefits of being in this study are that participants receive advice, support, recommendations, 
comprehensive written materials, and counseling that is designed to improve child and family health 
regardless of which condition they are randomized to receive. By participating in this program, 
participants increase the probability they will reduce their children’s SHSe and increase the chance 
that they will quit smoking.  As a result, both short- and long-term parental and child health may 
improve and disease risk may diminish. 
Given that tobacco use and exposure are leading causes of disease and death, the benefits of this 
research could include substantial public health impact. 
 
12) Privacy and Confidentiality 
This study has a very small risk of loss of privacy of personal participant information. Securing 
participant privacy is accomplished through several procedures and begins with the PIs’ thorough 
training and ongoing supervision of the research staff. The primary method of ensuring security of 
confidential data is with the use of a highly secure database configuration administered and 
overseen by the Co-PIs; and any data that staff collect will be directly and immediately brought by 
hand to Dr. Lepore’s research office and stored under lock and key. All databases are encrypted 
and password protected on password protected computers. Only Co-PIs and the Project Manager 
will have access to the passwords. Identifying information is used only for participant contact. No 
assessment forms, including urine and saliva cotinine assessment forms used to record collection 
and storage of samples, will have personal identifying information. Hard copies of identifying 
information will be stored in separate locked cabinets to avoid unauthorized cross-referencing of 
data with identifying information (and research assistants not involved with counseling will not be 
permitted to access counseling files.) These rules will be strictly enforced. Upon entry of data into 
the data management system, a participant ID will be generated.  ID numbers will not be derived 
from identifiable information. They are generated in numerical order based on their referral site. 


 
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ID numbers and names will be located in a separate encrypted table. All tables in the study data set 
use an automatically generated ID as the subject identifier.  Using this method, if security of the data 
in the study systems were to be compromised, no identifying subject information is present. Only the 
Project Manager (PM) will see all the data as specifically defined. Communication outside project 
staff will not have identifying information other than subject ID. An important note is that Dr. Lepore’s 
and Dr. Collins’ systems and individual study databases have never been compromised as a result 
of the rigorous and secure network firewall technologies they use in their labs. A secure server is 
located in a secured facility at Temple University, with dedicated uninterrupted power supply, and 
separate from other Temple University server systems. 
The research will collect and store subject Protected Health Information and will follow HIPAA 
regulations. The IRB has granted a waiver of HIPAA authorization for recruiting subjects. The 
protected health information will not be reused or disclosed to any other person or entity, except as 
required by law, for authorized oversight of the research study, or for other research for which the 
use or disclosure of the protected health information would be permitted. A HIPAA authorization 
form will be signed by the subject for the remainder of the study at the first home visit. Study results 
will be reported in aggregate. No individuals will be identified.  
Every effort will be made to help participants feel at ease with the study procedures. Interviews and 
phone sessions are scheduled in accordance with the participant’s schedule and participants are 
compensated for their time. The most sensitive questions (Adverse Childhood Experiences) are 
administered during the 12 month follow up home visit where the participant can fill out the 
questionnaire herself for privacy.  
 
13) Compensation for Research-Related Injury 
Not applicable. 
 
14) Economic Burden to Subjects 
There is minimal economic burden to subjects. Survey administration and health counseling both take 
place on the phone which could deplete a participants’ phone minutes. Study incentives are designed 
to offset the cost of phone minutes. Subjects may incur charges for use of smartphone apps depending 
on their cellular data plan. There will be no charge for downloading the apps. Both apps used are free. 
 
15) Consent Process 
We will follow INVESTIGATOR GUIDANCE: Informed Consent (HRP-802). 
Infants and children: A child (age 0 to 5) of the smoking parent will be included in the study: the 
parent will obtain a urine sample from their child to confirm level of exposure to secondhand smoke 
via a cotinine assay. The permission of one parent is sufficient even if both parents are alive, 
known, competent, reasonably available, and shares legal responsibility for the care and custody of 
the child. Assent of the child will not be obtained because their capability is so limited that they 
cannot reasonably be consulted. It will be the parent’s responsibility to collect the sample from the 
child, not a member of the research team. At no point in time is the child required to answer any 
questions or directly interact with research staff in the study.  
Cognitively impaired adults: During the eligibility screen, staff are trained to evaluate the participant for 
cognitive impairment. If there is any question, staff consult with the project manager or one of the 


 
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Principal Investigators to make a determination. If the person is deemed to have a cognitive impairment 
they are informed that they are ineligible for the study.  
Non-English-speaking subjects: Non-English speaking subjects will not be enrolled in the research. 
16) Process to Document Consent in Writing 
Consent will be read during the eligibility screen if the participant wishes to know more about the study.  
During the first home visit (within 2 weeks of eligibility) participants will be provided with a written copy 
of the consent form, which study staff will review with them. They will then be asked to sign a hard copy 
for study staff to keep on record.  
The research staff and protocol will follow INVESTIGATOR GUIDANCE: Documentation of Informed 
Consent (HRP-803) to obtain documentation of consent. The IRB has granted a waiver of 
documentation of consent for the screening phone call. The person obtaining consent will read the 
consent script to the subject during the phone screen before commencing any data collection. 
Documented consent will be obtained with the first home visit. 
17) Vulnerable Populations 
 
Study participants will predominantly include medically underserved and minority (African 
American) mothers who smoke. Maternal smokers are targeted primarily because child secondhand 
smoke exposure (SHSe) relates primarily to maternal, not paternal smoking. African Americans are 
also an important group to include because tobacco- and child SHSe-related morbidity and mortality 
is highest in this ethnic group. Mothers 18 and older will be included. Younger parents will not be 
included because they represent a developmentally different subpopulation with different sets of 
factors associated with smoking. The present intervention is not designed to meet these 
developmental differences. Nursing women will be eligible to participate. Nicotine replacement 
therapy will not be offered to nursing women unless they have written physician approval. There is 
no known risk for nursing women compared to the general population of women to participate in this 
type of counseling intervention to facilitate smoking cessation and reduction of child SHS exposure.  
A child of the smoking parent will be included in the study: the parent will obtain a urine sample 
from their child to confirm level of exposure to secondhand smoke via a cotinine assay. It will be the 
parent’s responsibility to collect the sample from the child, not a member of the research team. At 
no point in time is the child required to answer any questions or directly interact with research staff 
in the study. We will not enroll pregnant women, prisoners, or adults who are unable to consent. 
 
18) Drugs or Devices 
 
Participants randomized to the MBI intervention will receive a free 2-week supply of nicotine 
polacrilex replacement therapy (NRT) gum or lozenge, which is the standard practice among state 
quitlines. NRT will be kept in a locked cabinet in the lab and distributed directly to study participants 
during the baseline home visit. Following best-practice guidelines participants will receive 
counseling on how to use it in conjunction with a quit day set at the treatment orientation. 
Participants will learn how to obtain additional NRT (i.e., advice on: [a] obtaining an NRT 
prescription if they are insured and do not have a primary care provider; and [b] Medicaid co-pays 
and reimbursement procedures). Subjects in the MBI group will receive up to 8 weeks of nicotine 
polacrilix. Study counselors will give advice on NRT use based on guidelines6,7 including benefits 
and harms, safe use and disposal. Special instructions will be provided for nursing women (per FDA 
guidelines8). Free samples will be provided to nursing women only with physician approval, and 
adverse side effects will be monitored during counseling and assessment. NRT will be purchased 


 
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online through amazon. NRT will be administered following quitline guidance but within accordance 
to the FDA-approved labeling and use of the drug. 
With regards to the use of nicotine polacrilex: a) the investigation is not intended to be reported to FDA 
as a well-controlled study in support of a new indication for use nor intended to be used to support any 
other significant change in the labeling for the drug, b) the investigation is not intended to support a 
significant change in the advertising for the product, and c) the PI and other research personnel will not 
represent the drug as safe or effective for the purposes for which it is under investigation, or promote, 
commercially distribute, or test market the drug. 
The QuitPal and Fooducate smartphone apps are devices being used in this research. Per FDA 
guidance “Mobile Medical Applications,” abbreviated IDE requirements will not be followed because of 
functionality of these two apps does not pose a risk to a patient’s safety if the mobile apps were to not 
function as intended. 
19) Multi-Site Human Research 
Temple study staff will have regular meetings with Dr. Kilby (Co-I) and the NORTH, Inc. staff to apprise 
them of study progress and address any questions or concerns that arise. The Project Manager will be 
responsible for sharing any new information or unanticipated problems with the NORTH, Inc. staff in a 
timely manner. Information from the study will be shared with NORTH Inc. in aggregate, no identifiable 
information will be shared. 
 
20) Sharing of Results with Subjects 
Study results will not be shared with participants beyond published data. 
 
REFERENCES 
1 Baxi R, Sharma M, Roseby R, et al. Family and carer smoking control programmes for reducing 
children’s exposure to environmental tobacco smoke. Cochrane database Syst Rev. 2014;3:CD001746. 
2 Lepore SJ, Winickoff JP, Moughan B, et al. Kids Safe and Smokefree (KiSS): a randomized 
controlled trial of a multilevel intervention to reduce secondhand tobacco smoke exposure in 
children. BMC Public Health. 2013;13:792. 
 
3 Collins BN, Nair US, Hovell MH, Wileyto EP, Audrain-McGovern J. Effects of counseling and 
other smokers on child SHS exposure in a trial with underserved maternal smokers. Presented at 
the Society of Behavioral Medicine. In: Philadelphia, PA; 2014. 
 
4 NAQC. North American Quitline Consortium. Quitline Services offering models: A review of the 
evidence and recommendations for practice in times of limited resources. 2012. Available at: 
http://c.ymcdn.com/sites/www.naquitline.org/resource/resmgr/Issue_Papers/QuitlineServiceOffering
Model.pdf?hhSearchTerms=%22Quitline+and+Services+and+offering+and+models+and+review%2
2 Accessed May 2, 2014. 
 
5 U.S. Department of Health and Human Services. Best Practices for Comprehensive Tobacco 
Control Programs—2014. Centers Dis Control Prev Natl Cent Chronic Dis Prev Heal Promot Off 
Smok Heal 2014. 2014. Available at: 
http://www.cdc.gov/tobacco/stateandcommunity/best_practices/index.htm?source=govdelivery 
Accessed May 1, 2014. 
 


 
Page 16 of 16 
    
6 U. S. Department of Health and Human Services. Clinical Practice Guideline. Treating Tobacco 
Use and Dependence: 2008 Update. 2008;2009 SRC. Available at: 
http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.chapter.28163. 
 
7 Kozlowski LT, Giovino GA, Edwards B, et al. Advice on using over-the-counter nicotine 
replacement therapy-patch, gum, or lozenge-to quit smoking. Addict Behav. 2007;32(10):2140–
2150. 
 
8 U. S. Food and Drug Administration. FDA 101: Smoking cessation products. 2013. 
 
9 Stead LF, Perera R, Lancaster T. A systematic review of interventions for smokers who contact 
quitlines. Tob Control. 2007;16 Suppl 1(Suppl_1):i3–8. 
 
10 Husten CG, Rosenthal AC. Telephone quitlines: a resource for development, implementation, 
and evaluation. Available at: http://www.cdc.gov/tobacco/pubs.htm. Atlanta, GA 
 
11 Stead LF, Hartmann-Boyce J, Perera R, Lancaster T. Telephone counselling for smoking 
cessation (review). The Cochrane database of systematic reviews CD002850. 2013;8. 
 
12 Cummins SE, Bailey L, Campbell S, Koon-Kirby C, Zhu S-H. Tobacco cessation quitlines in 
North America: a descriptive study. Tob Control. 2007;16 Suppl 1(Suppl_1):i9–15. 
 
 
13 Beck AT, Wright FD, Newman CF, Liese BS. Cognitive therapy of substance use. New York: 
Guilford Press; 1993. 
 
14 McAfee T. Developing and improving toll-free tobacco quit line services. A World Health 
Organization manual. Geneva, Switzerland; 2011. 
 
15 Fiore MC. Treating tobacco use and dependence: an introduction to the US Public Health 
Service Clinical Practice Guideline. Respir Care. 2000;45(10):1196–1199.