Computer-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) for Marijuana Use in Pregnancy: Planning a Stage II Trial
Phase: NA
Conditions: Marijuana Use, Pregnancy
Sponsor: Wayne State University

Computer-based SBIRT for marijuana use in pregnancy: Planning a Stage II trial 
Version 2 
Protocol 1 
4/17/2018 
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Computer-based SBIRT for marijuana use in 
pregnancy: Planning a Stage II trial 
NIDA Grant Number: R34DA036788 
Principal Investigator: Steven J. Ondersma, Ph.D. 
NIDA Program Official: Jacqueline Lloyd 
Draft or Version Number:  2 
April 17, 2018 
 

Computer-based SBIRT for marijuana use in pregnancy: Planning a Stage II trial 
Version 2 
Protocol 1 
4/17/2018 
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 _____________________________________________________________________________________________  
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
1 
 
 
STATEMENT OF COMPLIANCE 
The study will be conducted in accordance with the International Conference on 
Harmonisation guidelines for Good Clinical Practice (ICH E6), the Code of Federal 
Regulations on the Protection of Human Subjects (45 CFR Part 46), and the NIDCR 
Clinical Terms of Award. All personnel involved in the conduct of this study have 
completed human subject protection training. 
SIGNATURE PAGE  
The signature below constitutes the approval of this protocol and the attachments, and 
provides the necessary assurances that this trial will be conducted according to all 
stipulations of the protocol, including all statements regarding confidentiality, and 
according to local legal and regulatory requirements and applicable US federal 
regulations and ICH guidelines. 
Principal Investigator or Clinical Site Investigator: 
Signed: 
 
Date:  
 
Name: Steven J. Ondersma, Ph.D. 
 
Title: Principal Investigator 

Computer-based SBIRT for marijuana use in pregnancy: Planning a Stage II trial 
Version 2 
Protocol 1 
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Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
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TABLE OF CONTENTS 
PAGE 
STATEMENT OF COMPLIANCE ................................................................................................. 1 
TABLE OF CONTENTS ................................................................................................................ 2 
LIST OF ABBREVIATIONS .......................................................................................................... 4 
PROTOCOL SUMMARY .............................................................................................................. 5 
1 
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ......... 8 
1.1 
Background Information ........................................................................................... 8 
1.2 
Rationale .................................................................................................................. 9 
1.3 
Potential Risks and Benefits ................................................................................... 10 
1.3.1 
Potential Risks ............................................................................................ 10 
1.3.2 
Potential Benefits ........................................................................................ 10 
2 
OBJECTIVES ..................................................................................................................... 11 
2.1 
Study Objectives/Outcome Measures .................................................................... 11 
2.1.1 
Primary ....................................................................................................... 11 
2.1.2 
Secondary .................................................................................................. 11 
3 
STUDY DESIGN ................................................................................................................ 12 
3.1 
Subject Inclusion/Exclusion Criteria ....................................................................... 13 
3.2 
Strategies for Recruitment and Retention .............................................................. 14 
3.3 
Treatment Assignment Procedures ........................................................................ 14 
3.3.1 
Randomization Procedures ........................................................................ 14 
3.3.2 
Masking Procedures (if applicable) ............................................................ 14 
3.4 
Subject Withdrawal ................................................................................................. 15 
3.4.1 
Reasons for Withdrawal ............................................................................. 15 
3.4.2 
Handling of Subject Withdrawals or Subject Discontinuation of Study 
Intervention ................................................................................................. 15 
3.5 
Premature Termination or Suspension of Study .................................................... 15 
4 
STUDY INTERVENTION ................................................................................................... 20 
4.1 
Study Behavioral or Social Intervention(s) Description .......................................... 20 
4.2 
Administration of Intervention ................................................................................. 23 
4.3 
Procedures for Training Interventionists and Monitoring Intervention Fidelity ........ 24 
5 
STUDY SCHEDULE .......................................................................................................... 25 
5.1 
Screening ............................................................................................................... 26 
5.2 
Enrollment/Baseline ............................................................................................... 29 
5.3 
Follow-up (Final) Visit ............................................................................................. 34 
6 
STUDY PROCEDURES /EVALUATIONS ......................................................................... 37 
6.1 
Laboratory Procedures/Evaluations ....................................................................... 37 
6.1.1 
Clinical Laboratory Evaluations .................................................................. 37 
6.1.2 
Specimen Preparation, Handling, and Storage .......................................... 37 
6.1.3 
Specimen Shipment ................................................................................... 39 
7 
ASSESSMENT OF SAFETY .............................................................................................. 40 
7.1 
Specification of Safety Parameters ........................................................................ 40 

Computer-based SBIRT for marijuana use in pregnancy: Planning a Stage II trial 
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Protocol 1 
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7.1.1 
Unanticipated Problems ............................................................................. 40 
7.1.2 
Adverse Events .......................................................................................... 41 
7.1.3 
Serious Adverse Events ............................................................................. 41 
7.2 
Characteristics of an Adverse Event ...................................................................... 41 
7.2.1 
Relationship to Study Intervention .............................................................. 41 
7.2.2 
Expectedness of SAEs ............................................................................... 41 
7.2.3 
Severity of Event ........................................................................................ 42 
7.3 
Reporting Procedures ............................................................................................ 42 
7.3.1 
Unanticipated Problem Reporting to IRB and NIDA ................................... 42 
7.3.2 
Serious Adverse Event Reporting to NIDA ................................................. 43 
8 
STUDY OVERSIGHT ......................................................................................................... 45 
9 
STATISTICAL CONSIDERATIONS ................................................................................... 46 
9.1 
Study Hypotheses .................................................................................................. 46 
9.2 
Sample Size Considerations .................................................................................. 46 
9.3 
Final Analysis Plan ................................................................................................. 46 
10 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS .................. 49 
11 
QUALITY CONTROL AND QUALITY ASSURANCE ......................................................... 50 
12 
ETHICS/PROTECTION OF HUMAN SUBJECTS ............................................................. 51 
12.1 
Ethical Standard ..................................................................................................... 51 
12.2 
Institutional Review Board ...................................................................................... 51 
12.3 
Informed Consent Process ..................................................................................... 51 
12.4 
Inclusion of Women and Minorities (Special Populations)...................................... 52 
12.5 
Subject Confidentiality ............................................................................................ 53 
13 
DATA HANDLING AND RECORD KEEPING .................................................................... 55 
13.1 
Data Management Responsibilities ........................................................................ 55 
13.2 
Data Capture Methods ........................................................................................... 55 
13.3 
Data Entry .............................................................................................................. 55 
13.4 
Schedule and Content of Reports .......................................................................... 56 
13.5 
Study Records Retention ....................................................................................... 56 
13.6 
Protocol Deviations ................................................................................................ 56 
14 
PUBLICATION/DATA SHARING POLICY ......................................................................... 57 
15 
LITERATURE REFERENCES ........................................................................................... 58 
 

Computer-based SBIRT for marijuana use in pregnancy: Planning a Stage II trial 
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Protocol 1 
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LIST OF ABBREVIATIONS 
AE 
Adverse Event/Adverse Experience 
CFR 
Code of Federal Regulations 
CONSORT 
Consolidated Standards of Reporting Trials 
DSMB 
Data and Safety Monitoring Board 
eCRF 
Electronic Case Report Form 
FDA 
Food and Drug Administration 
FWA 
Federalwide Assurance 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
IRB 
Institutional Review Board 
LC-MS/MS 
Liquid Chromatography-Tandem Mass Spectrometry 
MOP 
Manual of Procedures 
N 
Number (typically refers to subjects) 
NIDA 
National Institute of Drug Abuse, NIH, DHHS 
NIH 
National Institutes of Health 
PHI 
Protected Health Information 
PI 
Principal Investigator 
SAE 
Serious Adverse Event/Serious Adverse Experience 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
 

Computer-based SBIRT for marijuana use in pregnancy: Planning a Stage II trial 
Version 2 
Protocol 1 
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Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
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PROTOCOL SUMMARY 
Title: 
Computer-based SBIRT for marijuana use in pregnancy:  
Planning a Stage II trial 
Objectives: 
 
Primary:  Co-primary outcomes will include confirmed 7- 
and 90-day period-prevalence abstinence, and days of 
marijuana use in the past 90 days. All primary outcomes 
will be based on participant report during the postpartum 
timeline follow-back interview; the 7- and 90-day 
dichotomous abstinence measures will be confirmed using 
results from urine and hair toxicological analysis, 
respectively. Evidence of use from either the timeline 
follow-back interview or toxicological testing will result in 
that participant being considered non-abstinent. 
 
Secondary:  Secondary outcomes will include (a) birth 
outcomes from the Electronic Medical Record (EMR), 
including birth weight, length of hospitalization, and days in 
Neonatal Intensive Care; (b) help-seeking, particularly 
engagement in treatment services for marijuana use; (c) 
comparisons of the three intervention configurations 
(SBIRT only, texting only, or combined) to each other, 
rather than to the control condition; and (d) comparison of 
time-control and screen-only control participants.         
Population: 
Participants will be pregnant women age 18 to 40, 20 
weeks or less gestation, seeking care at the WSU UPG or 
Thea Bowman prenatal care clinics. 
Number of Sites: 
Wayne State University   
Description of  
Intervention: 
This R34 clinical trial planning grant proposes the 
development and preliminary validation of two high-reach 
and mutually compatible technology-based interventions for 
marijuana use during pregnancy:  an interactive computer-
delivered brief intervention, and a tailored text messaging 
intervention. 
Study Duration: 
21 months 
Subject Participation 
Duration: 
20 – 36 weeks (From prenatal appointment before 20 
weeks gestation until follow-up postpartum) 
Estimated Time to 
Complete Enrollment: 
21 months 

Computer-based SBIRT for marijuana use in pregnancy: Planning a Stage II trial 
Version 2 
Protocol 1 
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Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
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Schematic of Study Design: 
 
 
 
Principal 
Investigator:   
Steven J. Ondersma, PhD 
Wayne State University 
71 E. Ferry St. Detroit, MI 48202 
(313) 444-9797; (313) 664-2555 (fax) 
s.ondersma@wayne.edu  

Computer-based SBIRT for marijuana use in pregnancy: Planning a Stage II trial 
Version 2 
Protocol 1 
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Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
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NIDA Program 
Official:   
Jacquline Lloyd 
(301) 443-8892; (301) 443-8892 (fax) 
lloydj2@mail.nigh.gov 
Institutions: 
Wayne State University   
Other Key 
Personnel: 
Karoline Puder, MD 
Wayne State University 
James Janisse, Ph.D. 
Wayne State University 

Computer-based SBIRT for marijuana use in pregnancy: Planning a Stage II trial 
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1 INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE  
1.1 Backgrou
nd Information 
 
The public health impact of marijuana is substantial by any measure, particularly with 
respect to its use during pregnancy. This is true for at least three reasons. First, 
marijuana is by far the most commonly used illicit drug in the U.S., and marijuana use 
disorders alone are as prevalent as disorders related to all other drugs combined, 
including pain relievers (SAHMSA, 2012). This relative prevalence extends to 
pregnancy:  a total of 4.1% of all pregnant women (7.0% of African-American women) 
report use of marijuana in the past month, as opposed to 1.3% for all other illicit drugs 
combined (SAHMSA, 2012); this is also markedly higher than the rate of binge alcohol 
use in the past month (2.6%) among pregnant women. Second, although non-problem 
use is common, many marijuana users do experience social and health consequences 
as a result of their use. For example, in a previous sample of 112 post-partum women 
who reported any marijuana use prior to pregnancy, 85.7% met World Health 
Organization/ASSIST screener (Newcombe, Humeniuk, Hallet, & Ali, 2003) criteria for a 
brief intervention; 71.7% reported daily or almost daily desire to use marijuana, 40.2% 
reported having a friend or family member express concern about their level of use, and 
60.8% admitted to previously trying and failing to control their marijuana use. Frequent 
marijuana use may also be associated with compromised pulmonary functioning 
(Tetrault et al., 2007), greater tar deposits than from cigarettes (Mehra, Moore, 
Crothers, Tetrault, & Fiellin, 2006), increased likelihood/exacerbations of schizophrenia 
(e.g., Moore et al., 2007), and impairments in executive cognitive functioning (Crean, 
Crane, & Mason, 2011). Third, marijuana use during pregnancy—although 
inconsistently associated with poor birth outcomes—has  been associated with a range 
of negative neurobehavioral effects (e.g., Minnes, Lang, & Singer, 2011). In addition, 
ongoing parental use of marijuana after childbirth has also been associated with 
negative child outcomes, such as increased risk of behavior problems (Chatterji & 
Markowitz, 2001) and increased marijuana use disorder symptoms at age 18-20 (Buu et 
al., 2009). Marijuana use in pregnancy cannot be safely ignored. 
 
Marijuana use in pregnancy is substantially under-studied. Despite being by far the 
most prevalent illicit drug of abuse among pregnant women (Substance Abuse and 
Mental Health Services Administration, 2012), and despite its now eclipsing tobacco use 
in at least one sample of pregnant women (Beatty, Svikis, & Ondersma, 2012), there 
are currently no randomized trials evaluating interventions for marijuana use in this 
crucial population. This is unacceptable:  although evaluated in fewer studies, research 
suggests that the long-term consequences of prenatal marijuana exposure may be 
similar to that of other drugs of abuse, with evidence for subtle but meaningful long-term 
effects on IQ (Goldschmidt, Richardson, Willford, & Day, 2008), academic achievement 
(Goldschmidt, Richardson, Willford, Severtson, & Day, 2012), response inhibition 
(Smith, Fried, Hogan, & Cameron, 2004), delinquency (Day, Leech, & Goldschmidt, 
2011), and later substance use (Porath & Fried, 2005). Further, unique among all 

Computer-based SBIRT for marijuana use in pregnancy: Planning a Stage II trial 
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substances of abuse, marijuana is vigorously promoted as safe by a visible grassroots 
community without a counterbalancing public health message (Beatty et al., 2012). 
There is tremendous need for an evidence-based response in this area. 
 
Proactive technology-based interventions may be an ideal first element in a 
comprehensive response to substance use in pregnancy. Often deployed in primary 
care settings, such interventions have been proven efficacious (for example, see 
systematic reviews and meta-analyses by Portnoy, Scott-Sheldon, Johnson, & Carey, 
2008; Riper et al., 2009; Rooke, Thorsteinsson, Karpin, Copeland, & Allsop, 2010). 
Technology-delivered interventions are also uniquely applicable with non-treatment-
seeking populations, who may refuse extended treatment but accept a minimal, 
opportunistic intervention. Their privacy, ease of use, and ability to work independently 
of medical staff give them very high potential reach, and thus the potential for a 
substantial population impact. Their potential is further enhanced by the relative ease of 
implementation in the community.  
 
Study aims are to develop theory-based eSBIRT and text messaging interventions with 
expert and participant feedback; to randomize 80 pregnant women to eSBIRT, text 
messaging, combined, or control conditions (n = 20 each, with the control condition 
being further split between time control and screen-only); and to conduct postpartum 
follow-up to measure marijuana use and other secondary outcomes.         
 
1.2 Rationale 
 
Importantly, results from our lab (the Parent Health Lab) of similar approaches with 
tobacco use during pregnancy (DA021668) and prenatal alcohol use (AA020056) have 
been encouraging. This lends support to the feasibility of the present application, as well 
as to the larger goal of this line of research:  the establishment of a single software 
package that can flexibly and effectively address multiple substances. Additionally, 
behavioral science appears to have reached a point in the technology adoption life cycle 
in which early efforts have begun to give way to systematic reviews that can drive the 
field forward in important ways. 
 
This R34 clinical trial planning grant therefore proposes the development and 
preliminary validation of two high-reach and mutually compatible technology-based 
interventions for marijuana use during pregnancy. The first, a theory-based, 
synchronous, and highly interactive computer-delivered brief intervention, will be based 
on an emerging knowledge base regarding key elements of efficacious technology-
delivered interventions. The second intervention, a series of tailored text messages, will 
build on the rich literature regarding key tailoring elements. These interventions will be 
developed and refined with input from pregnant women who report active use of 
marijuana, as well as from health care providers. They will subsequently be tested—
alone and in combination—in a pilot randomized trial involving 80 women actively using 
marijuana during pregnancy. This Stage IA and IB pilot work would set the stage for a 

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confirmatory Stage II trial. It would also produce the first high-reach brief interventions 
for marijuana use during pregnancy.  
1.3 
Potential Risks and Benefits 
1.3.1 Potential 
Risks 
 
The primary potential risk of this type of research involves legal/child protective services 
repercussions due to drug (marijuana) use during pregnancy. Some additional risk may 
be present due to potential distress regarding evaluation of multiple sensitive areas.  
 
We believe that the risks to participants in this study are minimal, particularly given the 
positive nature of the intervention and the plan to seek a Federal Certificate of 
Confidentiality. We believe that the minor risks that are present are justified given the 
tremendous potential of this research to produce: (a) a method of identifying a large 
proportion of women using marijuana during pregnancy; and (b) two replicable, high-
reach, and low-cost interventions that are designed for pregnant women. These 
interventions, then, could potentially be presented to large numbers of pregnant women 
in a way that is financially and logistically feasible 
1.3.2 Potential 
Benefits 
 
Just over half of participants in this study will receive one or more brief, positive 
interventions designed to promote reductions in marijuana use during pregnancy. These 
participants and their infants may benefit from the intervention. The other participants in 
this study will not receive any form of intervention and are not expected to derive any 
clear benefit. 

Computer-based SBIRT for marijuana use in pregnancy: Planning a Stage II trial 
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2 OBJECTIVES 
2.1 
Study Objectives/Outcome Measures 
2.1.1 Primary 
Co-primary outcomes will include confirmed 7- and 90-day period-prevalence 
abstinence, and days of marijuana use in the past 90 days. All primary outcomes will be 
based on participant report during the postpartum timeline follow-back interview; the 7- 
and 90-day dichotomous abstinence measures will be confirmed using results from 
urine and hair toxicological analysis, respectively. Evidence of use from either the 
timeline follow-back interview or toxicological testing will result in that participant being 
considered non-abstinent.  
2.1.2 Second
ary 
Secondary outcomes will include (a) birth outcomes from the Electronic Medical Record 
(EMR), including birth weight, length of hospitalization, and days in Neonatal Intensive 
Care; (b) help-seeking, particularly engagement in treatment services for marijuana use; 
(c) comparisons of the three intervention configurations (SBIRT only, texting only, or 
combined) to each other, rather than to the control condition; and (d) comparison of 
time-control and screen-only control participants. 

Computer-based SBIRT for marijuana use in pregnancy: Planning a Stage II trial 
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Protocol 1 
4/17/2018 
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3 STUDY DESIGN 
The first year of this project will be devoted to development of the eSBIRT and text 
messaging interventions, with refinement following feedback from participants meeting 
the same inclusion and exclusion criteria as the proposed pilot trial (e.g., pregnant and 
reporting active marijuana use). All activities in this phase will be the result of close 
collaboration between the PI and the rest of the investigative team, particularly Dr. 
Resnicow, Dr. Svikis, and Ms. Konkel (Consultants from University of Michigan and 
Virginia Commonwealth University). The investigative team will meet regularly with the 
PI, both individually and as a group via Skype or web conferencing using 
“GoToMeeting” software to facilitate screen sharing.  
 
Overview 
We will initiate the N = 80 pilot randomized trial following development and modification 
in response to feedback, after participant ratings have exceeded our a priori criteria for 
acceptability. The primary goal of this phase will be to pilot test the interventions, alone 
and in combination, to further evaluate feasibility/acceptability, explore potential 
mechanisms, and inform effect-size estimation. Even with limited power, 2 X 2 designs 
are ideal for Stage I trials: they provide richer data to inform Stage II and allow 
collapsing across factors that prove unrelated to outcome (thus making efficient use of 
available participants), yet maximize the proportion of participants who receive an 
intervention (facilitating analysis of feasibility and acceptability). Details are provided 
below. 
 
Participants 
 
Participants will be 80 pregnant women at less than 20 weeks gestation, recruited from 
a WSU Ob-Gyn clinic and the Thea Bowman family community health clinic (working 
with the nurse midwife on staff). Participants will be excluded if they are considering 
termination of the pregnancy or giving the baby up for adoption, are planning to deliver 
outside of the DMC Hutzel Hospital (over 90% of patients at this clinic deliver at Hutzel), 
are deemed unable to understand the consent process, or are unable to understand 
spoken English. We have had clear success using a similar approach in prior studies. 
Past samples have been predominantly African-American and low-income (e.g., 
Ondersma, et al., 2007).    
 
Measures 
 
Given the context of data collection, the overall battery was designed to be thorough yet 
brief. The brief versions of all measures will be repeated at follow-up, along with more 
extended assessment in key areas. All measures listed below are well validated, 
commonly used in NIH-funded trials, have been used successfully in our previous work, 
and/or are taken from the NIDA Clinical Trials Network (CTN) common assessment 
battery. Urine samples will be analyzed by Redwood Toxicology, Inc., and hair samples 
by USDTL Laboratories. All measures will be administered via the CIAS ACASI 

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functionality, other than the questions about use of technology completed on the paper 
calendar used for the Timeline Follow-back interview.  
 
The baseline assessment battery below will not be administered at baseline to 
participants in the screen-only control group; however, all measures will be 
administered to all groups at follow-up. Finally, note that the follow-up assessment 
battery includes assessment of the usefulness and impact of the intervention materials, 
as well as of the timing and reasons behind any attempts to quit or cut down on 
marijuana use. This information will greatly assist us in evaluating the timing and 
manner of any intervention-related change, and will assist in planning the subsequent 
Stage II trial.   
  
Table 2. Study measures at baseline and follow-up  
Baseline Follo
w-up 
1. Demographics  
X 
X
2. Drug-Taking Confidence Questionnaire (marijuana self-efficacy)
X 
X
3. ASSIST substance use screener (7 items per substance 
X 
X
4. CESD-10 (depression) 
X 
X
5. Motivation Measurement Scales (visual analog)
X 
X
6. Satisfaction with CIAS software 
X 
7. Short Index of Problems-Revised 
X 
X
8. Items to inform tailoring (timing/freq, stage, attitudes)
X 
X
9. Theory of Planned Behavior & Self-Det. Theory Questions 
X 
X
10. Pregnancy related anxiety scale 
X 
11. Urine & hair sample (tested for drugs)
 
X
12. Birth outcomes (birth weight, gestation, days in hospital/NICU)
 
X
13. Substance Use Calendar (TimeLine Follow Back – TLFB)
 
X
14. Mini International Neuropsychiatric Interview (MINI)
 
X
15. Cannabis Abuse Screening Test (CAST) and ALAC
 
X
16. Substance use in home/peer group/significant relationships
 
X
17. Conflict Tactics Scale (CTS-II)
 
X
18. Brief Child Abuse Potential Inventory (BCAP)
 
X
19. Wayne Indirect Drug Use Screener (WIDUS)
 
X
20. HRBS (HIV risk measure) 
 
X
21. Prescription Drug Use Questions 
 
X
22. Motivation to Change  
 
X
23. Medical Marijuana Use Questions
 
X
24. Kirby 
 
X
25. Primary Care PTSD Screen (PC-PTSD)
 
X
26. Satisfaction with Text message & study
 
X
27. Questions about use of technology
 
X
 
3.1 Subject 
Inclusion/Exclusion Criteria 
 
Inclusion criteria   
 
Age 18 to 40, pregnant, seeking care at the DMC/UHC or Thea Bowman prenatal 
clinics, able to communicate in English, own a cellphone and willing to receive text 
messages, willing to allow access to their pending newborn's birth records, less than 20 
weeks pregnant, and reporting marijuana use at least twice weekly in the month before 
becoming pregnant.  
 
Exclusion criteria 

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Frank cognitive impairment, considering an elective abortion or adoption, not able to 
communicate in English, not planning to deliver at a DMC hospital, previous or current 
research participant in a study conducted by Dr. Ondersma, or already a participant with 
the NICHD Perinatal Research Branch. 
3.2 
Strategies for Recruitment and Retention 
Many techniques and communications are employed to orient each participant from 
enrollment to completion of participation after follow up appointments. This includes all 
of the correspondences described in the Correspondence Schedule, some of which are 
detailed here. About one week after enrollment, a research assistant sends a thank you 
card by mail or email to the participant. A reminder card is mailed about 14 weeks 
before the participant’s due date reminding them about the follow-up when their baby is 
born. A phone call is made 8 weeks before their due date to serve as an additional 
reminder and confirm due date and planned hospital for delivery of the infant. 
Additionally, holiday, Thanksgiving and birthday cards are mailed or emailed if 
appropriate given dates between original enrollment and birth of infant. Approval to 
track participants through their medical records was obtained during consent.  We have 
a DMC nurse who checks census for Hutzel hospital to know when participants deliver. 
Participants are compensated with a $50 Target gift card at baseline.  For the follow-up 
visit they are compensated with a $50 Target gift card and an additional $25 Target gift 
card if they provide a hair & urine sample.  
3.3 Treatment 
Assignment Procedures 
3.3.1 Randomiz
ation Procedures 
 
Randomization is determined by CIAS when first given a computer ID during enrollment 
and baseline data collection at a rate set by research administrators. All participants who 
screen eligible for the RCT are randomized to one of four conditions: eSBIRT only, Text 
message only, eSBIRT and Text message, or Control (split evenly between Screen only 
or Screen & Assessment). The PI and Project Coordinator monitor the randomization rate 
to ensure that equal numbers of participants are randomized to each condition: 20 to 
Control (10 to each Screen and Assessment conditions) and 20 to each Intervention 
condition (eSBIRT, Text, & Both).  
3.3.2 
Masking Procedures (if applicable) 
 
This is a blinded study, meaning that outcomes assessor is blinded to the participant’s 
randomization condition, but the PI and Project Coordinator have access to that condition. 
Participants are informed in the consent form that they will be randomly placed into one 
of the four conditions. CIAS automatically randomizes all eligible participants to one 

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condition. At the end of the assessment and intervention package, CIAS delivers a brief 
summary of the participant’s tailoring conditions in order for the research assistant to 
assure those participants placed into the text message condition receives a welcome text. 
3.4 Subject 
Withdrawal 
 
Participants are free to withdraw from the study without changing any present or future 
relationship with Wayne State University or any of its affiliates.  The PI may withdraw 
participants as well. If the PI makes this determination, participants will be told.  The 
decision is made only to protect participants health and safety, or because the participant 
did not follow instructions to take part in the study. 
3.4.1 
Reasons for Withdrawal 
 
Participants are notified in the consent form that their participation is voluntary and that 
they may withdraw from the study at any time without affecting their health care. They are 
not obligated to provide a reason for withdrawing, though suspected reasons might 
include the sensitive nature of certain questions, health concerns for their infant, lack of 
ability to receive regular text messages, or a lack of available time to complete baseline 
appointment.   
3.4.2 
Handling of Subject Withdrawals or Subject Discontinuation of Study 
Intervention 
If withdrawal occurs due to health concerns or discomfort with questions, this is noted 
on tracking spreadsheets so that the participant is no longer contacted. If appropriate, 
sympathy cards are sent to participants who experience traumatic events. Subjects who 
unofficially withdraw due to loss to follow up are reported during progress reports. 
3.5 Premature 
Termination or Suspension of Study 
 
An IRB shall have authority to suspend or terminate approval of research that is not being 
conducted in accordance with the IRB’s requirements or that has been associated with 
unexpected serious harm to subjects. Any suspension or termination of approval shall 
include a statement of the reasons for the IRB’s action and shall be reported promptly to 
the investigator, appropriate institutional officials, and to the Department or Agency Head. 
[45 CFR 46.113; 38 CFR 16.113 Suspension or Termination of Research.] 
 
To fulfill the regulatory requirements (as noted above), Wayne State University (WSU) 
has authorized the Institutional Review Board (IRB), the individual Institutional Review 
Boards (IRBs,Committees) and/or the Committee Chairs or the Assistant/Associate Vice 

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President for Research (AVPR), to suspend or terminate a research project that is not 
being conducted in accordance with the IRB’s requirements and/or that may pose 
increased risks and/or unacceptable risks to the safety and welfare of human research 
subjects. Additionally, any of the above entities or individuals can suspend the human 
research activities of an investigator who has committed serious or continuing non-
compliance in order to assess and/or remediate the problem(s). Suspension or 
termination would occur when there are issues of continuing or serious noncompliance 
with IRB and federal requirements, when the research is associated with unexpected 
serious harm to research participants, or when there are immediate serious issues 
involving participant safety. 
 
Key Definitions 
Committee – Refers to the individual IRBs at Wayne State University. 
Designee – A person appointed by the IRB Chair, acting on his/her behalf. 
Confirmed Non-Compliance – Non-compliance (as defined below) that has been verified 
as a result of a for-cause audit or investigation. 
Continuing Non-Compliance –  A repeated pattern of non-compliance with all federal 
regulations, including Veterans regulations and guidance, by an individual investigator or 
research staff member either on a single protocol or multiple protocols. 
Non-Compliance – The failure to comply with all federal regulations, including Veterans 
Administration regulations and guidance, state and local requirements, WSU Policy and 
determinations of the IRB. 
Serious Non-Compliance – The failure to comply with all federal regulations, including 
Veteran’s Administration regulations and guidance, state and local requirements, WSU 
Policy and determinations of the IRB that involve one or more of the following: 
 Harm to research participants; 
 Exposing research participants to a significant risk of substantive harm; 
 Comprising the privacy and confidentiality of research participants; 
 Damage caused to scientific integrity of the research data that has been collected; 
 Willful or knowing non-compliance on the part of the investigator; and 
 Adversely impacting ethical principles 
 
(See IRB Policy: “Identifying, Defining, and Managing Non-Compliance in Human 
Research” for specific examples). 
Suspension – A suspension occurs when the IRB Committee, IRB Chair, or AVPR places 
a temporary hold on the research that had been previously approved so that no new 
participants can be accrued, no research interventions may occur (unless necessary for 
the safety and well-being of the enrolled participants), and no follow-up can be conducted 
unless it is in the best interest of the participant and approved by the IRB. 

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Termination of a previ ously approved protocol –  Termination of a previously approved 
protocol occurs when the IRB Committee, IRB Chair, or AVPR withdraw approval or stop 
all research activity permanently. No new participants may be enrolled and no additional 
research interventions can occur. However, future follow-up may be conducted with the 
approval of the IRB to monitor the well-being and any potential risk to participants. 
Termination of activities that have nev er received prior review and approval –  On the 
occasion when research activities have occurred that did not receive prior review and 
approval from the IRB, the IRB shall stop all such activities permanently. None of the data 
collected in this activity can be used in any future publication or presentation. 
Unexpected Problem –  An unexpected problem is associated with any aspect of the 
research study that may involve not only risks to the participant enrolled in a research 
study, but to other individuals who may or may not be directly associated with the research 
study. Unexpected problems may occur in non-clinical (behavioral or social science) as 
well as clinical research studies (see IRB Policy and Procedure “Unexpected Problems 
Involving Risk to Participants” for an inclusive list of categories). 
 
IRB Procedures 
Prior to, or during, the process of suspending or terminating a previously approved 
research protocol or research activities that have been conducted without prior approval, 
a for-cause audit will be conducted. The results of this audit will be provided to the AVPR, 
the IRB Chairs and Committee Members as a part of their decision to suspend and/or 
terminate a research protocol (see IRB Policy and Procedure “For-Cause Audit”). 
 
When other administrative groups within the University have suspended a research 
activity for an issue involving human participants, they are required to notify the IRB within 
5 business days. An investigation will be done and an audit may be conducted by the IRB 
as part of their decision to suspend and/or terminate the research protocol. These results 
of the above actions may range from corrective or educational measures for the 
researcher up to and including the termination of all research activities. Further, the IRB 
may suspend the approval of research projects at any time during an inquiry or 
investigation to assure the protection of human participants. 
 
Suspension of a Research Protocol 
When reviewing an unexpected problem, the IRB or IRB designee may determine that 
the protocol associated with the unexpected problem should be suspended. 
 
In addition, when there is concern that research is being conducted that is not in 
compliance with an approved research protocol, the IRB or IRB designee may suspend 
the research protocol until an internal audit has been completed. The completed audit 

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report will be reviewed by the IRB, to determine whether or not to terminate the IRB 
approval. 
 
As an alternative to termination, the IRB may impose a suspension and/or remedial 
actions to bring the research activities into compliance with the IRB requirements and to 
reduce the risk to participants. When the IRB has determined that all remedial actions 
have been implemented, the IRB may withdraw the suspension and the research may 
resume. 
 
Termination of a Research Protocol 
A research protocol is terminated: 
 When a remedial action plan approved by the IRB has not been implemented; or 
 When the IRB determines that it is in the best interest of the research participants. 
 
Due to safety issues and full disclosure (as outlined in the informed consent process), 
participants in the research must be notified in writing of all terminations. This notification 
must be approved by the IRB before it is sent to participants. A plan for safe withdrawal 
of participants from the research is required and should consider their rights and welfare, 
and must be submitted to the IRB for review and approval. If follow-up of the participants 
for safety and effectiveness reasons is permitted or required by the IRB, the participants 
should be informed after obtaining IRB review and approval of the notice. Any unexpected 
problems or other outcomes identified during follow-up should be reported to the IRB, the 
research study sponsor, and the FDA, if applicable. 
 
If the investigator wishes to resume a research protocol that has been terminated, it must 
be submitted as a new protocol. 
 
Terminating Research Activities Prior to IRB Review and Approval 
When research activities have occurred without prior review and approval, then all 
activities must cease immediately and the following process is followed: 
 The PI will be required to submit an Unexpected Problem Report/Form regarding 
the event; 
 A for-cause audit of all research documents will be conducted; 
 The investigator must verify in writing that none of the data will ever be used for 
research purposes in the future; 
 All paper documents and informed consent forms must be sent to the IRB office to 
be confiscated; 
 All computer files must be destroyed and a signed verification submitted by the PI; 
 Mandatory education of the investigator and research team will be conducted; 
 Appropriate University, IRB, Agency, and Sponsor entities will be notified. 

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Reporting of All IRB Suspensions and/or Terminations 
The suspension and/or termination of IRB approval of a research protocol will be promptly 
reported to the investigator by courier within 24 hours and will include a written statement 
of the reasons for the IRB’s actions. 
 
When research has been suspended and/or terminated, the Associate Vice President for 
Research will report the suspension and/or termination to other appropriate Institutional 
Officials, Departmental Chairs or Deans and appropriate regulatory agencies (e.g., 
Offices for Human Research Protection, Food and Drug Administration, Veterans Affairs, 
Sponsor, etc.) within 60 days of the suspension or termination (see IRB Policy and 
Procedure “Reporting of Unexpected Problems, Suspensions and Terminations, and 
Serious and Continuing Non-Compliance and the Institutional Official’s Responsibilities”).  
For VA requirements, in addition to reporting to ORO, the following offices must be 
notified: 
 The Privacy Office, when the report involves unauthorized use, loss, or disclosure 
of individually identifiable patient information. 
 The Information Security Officer when the report involves violations of information 
security requirements. 
 
PI Recourse 
The PI may request a meeting with the AVPR, IRB Committee or IRB Chair  or designee 
regarding any decision to suspend and/or terminate a protocol. This should be 
accompanied by a written appeal. 
 
Disciplinary Action 
While the IRB shall have the authority to suspend and/or terminate a research protocol, 
or any of an investigator’s human research activities, all disciplinary action taken against 
an individual for being out of compliance with institutional policies regarding the protection 
of 
human 
participants, 
shall 
be 
the 
responsibility 
of 
the 
institution. 
The 
Associate/Assistant Vice President for Research shall be responsible for reporting the 
termination to other institutional officials (Department Chairs, Deans, the Provost, etc., as 
required) and to assist in taking appropriate institutional disciplinary action. 

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4 STUDY INTERVENTION 
4.1 Stud
y Behavioral or Social Intervention(s) Description 
 
The eSBIRT intervention will be a single highly interactive session, delivered via a touch 
screen Tablet. The total planned duration of approximately 20 minutes is based on 
evidence suggesting that “longer” brief interventions (e.g., greater than ten minutes) are 
associated with stronger effects than shorter brief interventions (Fiore, Jaen, Baker, & et 
al., 2008), while also being cognizant of time limitations in a busy outpatient clinic. 
Participants will interact with the CIAS software and its animated narrator via a touch 
screen and headphones in a private office, prior to or after being seen by medical staff 
(see below for details regarding participants and recruitment).  
 
The intervention for this project will draw from our previously successful interventions for 
post-partum drug use and prenatal tobacco use (Ondersma et al., 2007, 2012), from 
Motivational Interviewing (e.g., Miller & Rollnick, 2002) and brief intervention 
approaches (e.g., Babor et al., 2007), as well as the growing literature supporting two 
specific theories of health-related behavior. This solid theoretical foundation will 
maximize efficacy and enhance our ability to examine mechanisms. This and other key 
elements of the proposed eSBIRT intervention are described below. 
 
1. Strong theoretical basis. This eSBIRT software will be based on the Theory of 
Planned Behavior (TPB; Ajzen, 1985) and Self-Determination Theory (SDT; Ryan & 
Deci, 2000), two theories that have garnered support in the literature and that are 
consistent with brief interventions for health behavior change. The following list 
describes the techniques that will be incorporated into the eSBIRT intervention and 
how those elements relate to one or both of these theories. This information is also 
summarized in Figure 4, below. Note that the use of multiple techniques is 
consistent with a recent meta-analysis showing that doing so is associated with 
stronger outcomes (Webb, et al., 2010).   
a. 
Empathic exploration of the participant’s thoughts regarding their marijuana use 
(supporting autonomy; SDT) 
b. 
With permission, provision of information on possible consequences of 
marijuana use during pregnancy and possible benefits of changing 
(modification of attitudes toward the behavior, TPB; supporting autonomy, 
SDT)  
c. 
Normed feedback and exploration of others’ approval of the behavior/potential 
change (addressing subjective norms, TPB; relatedness, SDT) 
d. 
Use of Motivational Interviewing strategies to elicit participants’ own reasons for 
change (modification of attitudes toward the behavior, TPB) 
e. 
Incorporation of video testimonials modeling successful change (modification of 
attitudes toward the behavior, TPB; perceived behavioral control, TPB; building 
autonomy and competence, SDT)    

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f. 
Provision of information regarding multiple change methods, and optional goal 
setting (perceived behavioral control, TPB; building autonomy and 
competence, SDT)    
__________________________________________________________________ 
 
 
2. 
Use of tailoring. Tailored health communications are associated with stronger 
effects than non-tailored communications (Noar, et al., 2007). Although tailoring has 
been incorporated into many messaging-based interventions (Hawkins, Kreuter, 
Resnicow, Fishbein, & Dijkstra, 2008; Resnicow et al., 2009), it has not been as 
widely implemented in technology-delivered brief interventions—which, although 
providing personalized feedback, have failed to vary their overall structure to fit 
each participant. This is critical, as tailored interventions are associated with 
stronger effects. Even more importantly, interventions tailoring on multiple 
theoretical, behavioral, and demographic characteristics together have stronger 
effects than those tailoring on only one of these (Noar et al., 2007). The proposed 
eSBIRT software will target pregnant women and will provide personalized 
feedback, but will go far beyond this by tailoring intervention components, order, 
language, and tone on individual factors such as age, race, motivation to change 
(e.g., willing to consider quitting vs. not at all open), changes made since learning of 
their pregnancy, self-efficacy, and social support (variables emerging as important 
in Noar et al., 2007).       
3. 
Non-specific factors.  The therapy outcome literature clearly shows the extent to 
which non-specific or “common” factors influence outcomes (e.g., Chatoor & 
Krupnick, 2001). Knowledge of the importance of such factors led to their being 
central to the very definition of Motivational Interviewing (Miller & Rollnick, 2002). 
Although of course technology-delivered interventions can never replicate a true, 
high-quality human interaction, they nevertheless can vary in perceived empathy, 
optimism, insight, responsivity, alliance, and respect. In part through leveraging the 

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synchronously interactive talking narrator available in CIAS, the eSBIRT 
intervention will maximize participant perceptions of empathy, etc., to the extent 
possible through this medium.   
4. 
Tailored video clips. Our recent computer-delivered intervention for cigarette 
smoking in pregnancy (Ondersma et al., 2012) included video clips containing 
information from a physician and a testimonial from a young mother that were 
embedded within CIAS as part of the intervention flow. These video clips were very 
well received, and appear to have contributed to the positive results of that 
intervention. The present intervention for prenatal marijuana use will also include 
video clips that are tailored based on age, race, current change/motivation status, 
and self-efficacy.       
5. 
Promotion of self-change and/or treatment-seeking. The overall goal of the eSBIRT 
intervention will be to promote self-change and/or help-seeking, which it will do in 
part by providing a range of nearby and accessible options for assistance (one’s 
physician, a faith leader, nearby opportunities for treatment, etc.). Rather than using 
a severity algorithm to determine which participants should be referred for 
assistance, this intervention will simply provide a menu of available options to all 
participants who have indicated some interest in change.        
      
Design and theoretical basis of tailored text intervention  
 
We will use group text messaging software developed within the CIAS program using 
Twilio to deliver the text messages. Consistent with Self-Determination Theory and 
Motivational Interviewing, we will seek to maximize autonomy by allowing participants 
assigned to the tailored text condition to choose the frequency (weekly, twice a week or 
three times a week) and time (morning, afternoon, evening, or nighttime) of text 
messages. Text messages will continue until childbirth or until the participant opts out.  
 
Following evidence that even use of a first name may enhance efficacy (Dijkstra, 2005), 
text messages will make regular use of the participant’s first name. As noted above, the 
text intervention will also tailor on factors such as participant gestational stage, self-
efficacy, social support, and will follow the key theoretical principles of the Theory of 
Planned Behavior and Self-Determination Theory noted in Figure 4 (e.g., text messages 
will strive to build perceived behavioral control and a sense of competence with regard 
to avoiding marijuana). We will work closely with Dr. Resnicow and Ms. Konkel in 
developing the text message language and algorithms. In order to maximize 
engagement and retention, messages will mix marijuana-targeted content with general 
content related to a healthy pregnancy (e.g., nutrition), as well as use of appropriate 
humor and tips for community resources.     
 
Participant protection is always an important consideration. This is especially true when 
working with pregnant women and illicit drug use, as this can potentially place them at 
risk for a range of negative consequences. Text messages, which could potentially be 
viewed in transit or by anyone with access to the participant’s mobile phone, present 
unique challenges in this regard. We carefully considered a number of options for 
dealing with this, and spoke with other investigators (some of whom are the first to do 

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texting regarding illicit drug use, albeit not with pregnant women). Although we 
understand that our ability to affect marijuana use would most likely be maximized by 
addressing it directly, we believe that (a) we are ethically required to avoid sending text 
messages that could directly implicate participants in illegal activity that could place 
them or their custody of their infant at risk; and (b) we can take a number of steps to 
maximize efficacy while still protecting participants. Therefore, text messages will never 
refer directly to marijuana in a way that implies its use by the participant. Instead, texts 
will refer only to “smoking,” without further clarification; the CIAS session for those 
assigned to the text conditions will clarify that marijuana is the primary focus of this 
study and that “smoking” is always used to refer specifically to marijuana use. Other 
texts will make reference to substances in general without presuming use (e.g., 
“Remember that babies grow best when they don’t get any tobacco, marijuana, alcohol, 
or other drugs. Moms who avoid these things give their baby a great gift”).  
 
4.2 Administration 
of Intervention 
 
The computerized intervention is delivered by a tablet with the aid of CIAS. This eliminates 
fidelity concerns because, pending no software glitches, packages are delivered the same 
way every time. After a positive screen for eligibility, the RA sets up the participant on the 
tablet.  The appropriate intervention arm is determined by the computer program once 
the ID number is assigned.  Participants then proceed on the tablet as directed to answer 
assessment questions and then proceeds to the intervention package (if appropriate). 
Pictures and videos appear on-screen, as well as questions and response options. 
Feedback regarding satisfaction and change beliefs is collected by the tablet post-
intervention. All data collected during tablet administration is transferred to the Wayne 
State server via an encrypted and protected transmission system.

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4.3 
Procedures for Training Interventionists and Monitoring Intervention 
Fidelity 
 
The intervention as described above does not require training interventionists or 
monitoring intervention fidelity in the traditional sense. Rather, the CIAS-authored 
intervention is delivered via the internet to the tablet computer for participants to interact 
and answer questions. CIAS is routinely checked for issues, though none have been 
found to date that were not easily fixed. Data is also analyzed for out-of-range values or 
entry errors monthly so that they may be identified, logged, and prevented in the future. 
This ensures an extremely high level of intervention fidelity and trial administration in 
general. 

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5 STUDY SCHEDULE 
 
Day 1 
o Recruit into study 
o Confirm preference of mail or email correspondence & receipt of text if in text 
message group 
o Emphasize post-partum follow-up and ask them to call us when at the hospital 
 
 
Day 5 
o Send thank you letter (either through postal mail or email) 
 
 
14 weeks before due date 
o Mail reminder card (postal or email) about follow-up appointment post-partum 
before discharged from hospital 
 
 
12 weeks before due date 
o DMC nurse checks post-partum unit census for participant once a day (alerts 
project coordinator if any participant listed in census) 
 
 
8 weeks before due date (if hasn’t already delivered) 
o Phone call to confirm due date & ask where planning to deliver 
o Check and see if they received reminder card 
o Answer any questions about follow-up appointment 
 
Try other contacts if participant not responding or number disconnected 
 
 
4 weeks before due date (if hasn’t already delivered) 
o DMC nurse checks post-partum unit census for participant twice a day (alerts 
project coordinator if any participant listed in census) 
o Phone call to confirm due date, remind of follow-up appointment and ask where 
planning to deliver 
 
Try other contacts if participant not responding or number disconnected 
 
 
Follow-up after baby is born, before mother discharged from hospital 
o Mother must 
 
Agree to participate 
 
Have slept since giving birth 
 
Not report distress about birth outcome 
 
No narcotic pain medications within past 3 hours 
 
o TLFB completed first (paper calendar filled out with personalized dates first) 
o CIAS assessment battery completed after TLFB complete 
o Hair & urine collected when appropriate 
 
 
Other mailings (postal mail or email depending on participants preference) during study  
- only if occurs while enrolled in study 
o Hard to contact mailing – when can’t reach by phone or through other contacts 
o Birthday card – sent 3 days before birthday 

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o Happy Holidays card 
 
Sent 3 days before Thanksgiving 
 
Sent in the middle of December for New Years and other holidays during 
this time 
5.1 Screening
 
 
Participants will be 80 pregnant women at less than 20 weeks gestation, recruited from 
a WSU UPG Ob-Gyn clinic or Thea Bowman. Participants will be excluded if they are 
considering termination of the pregnancy or giving the baby up for adoption, are 
planning to deliver outside of the DMC Hutzel Hospital (over 90% of patients at this 
clinic deliver at Hutzel), are deemed unable to understand the consent process, or are 
unable to understand spoken English. Note that participation in this phase will be 
anonymous, and will use an informed consent information sheet rather than written 
consent, since collecting identifying information would present unnecessary risk (45 
CFR 46.117). We have had clear success using a similar approach in prior studies. Past 
samples have been predominantly African-American and low-income (e.g., Ondersma, 
et al., 2007).    
 
Screening and recruitment 
 
Participants will be given a flyer by clinical staff at the clinics, alerting them to the 
existence of a voluntary study. Medical staff will indicate that the flyer describes a 
voluntary research project that involves 5-10 minutes to determine eligibility for a larger 
study and that they will receive a small gift for their baby if they choose to participate. 
Those showing tentative interest will be introduced to the research assistant, who will 
pre-screen for age, weeks gestation, ability to understand spoken English, and ability to 
receive and comfort receiving text messaging. Women passing this pre-screen process 
will be brought to a private room within the clinic where pre-screening will continue (i.e., 
intention to carry pregnancy to term). Those meeting this final pre-screen criterion will 
then be helped to review an informed consent information sheet (as used in prior NIH 
funded and IRB-approved studies; see 45 CFR 46.117). Those providing consent will 
use a Tablet PC with headphones (with disposable sanitary covers) to complete a brief 
screener evaluating a range of pregnancy-related health behaviors and emotions (e.g., 
nutrition, sleep, exercise, depression, anxiety, alcohol use, and smoking), as well as a 
key question regarding any marijuana use in the month prior to pregnancy.  (See 
recruitment script in section 3.2)  
 
The validity of this key question—any marijuana use in the month prior to pregnancy—
has been supported; in a recent study from our lab, it was shown to be significantly 
more accurate than the Drug Use Screening Test (Skinner, 1982) in predicting drug use 
during pregnancy, as measured by hair and urine toxicology (Ondersma, Svikis, 
LeBreton, et al., 2012). In unpublished results specifically focused on marijuana use, 
only indirect screening (that is, screening that does not address marijuana use in any 
way) achieved higher sensitivity in predicting hair and urine toxicology. Notably, other 

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screening tools typically achieve high sensitivity and specificity values, but only when 
using a self-report gold standard, a methodology that can lead to inflated accuracy 
estimates when under-reporting is present, as it often is during pregnancy (Grekin et al., 
2010; Ondersma, Svikis, LeBreton, et al., 2012). This under-reporting also means that 
sensitivity and reach can be maximized by asking about use prior to pregnancy. We will 
also seek to minimize under-reporting by contextualizing the drug use question within a 
broader screening process; through the use of Audio Computer-Assisted Self-Interview 
(ACASI) technology for the key eligibility criterion, as these approaches are associated 
with greater disclosure of drug use (e.g., Newman et al., 2002); and by ensuring 
anonymity at this step (Chase, Beatty, & Ondersma, 2011; Durant, Carey, & Schroder, 
2002). 
Recruitment Script Introduction 
 
Initial contact with potential participants sets the tone for the interaction between 
researcher and research participant. The research assistant (RA) must approach the 
participant with respect, consideration for personal time and space, and with 
awareness of the need to maintain confidentiality.  
 
Pregnant women will be recruited at or before 20 weeks gestation. The medical staff 
member (medical assistant, nurse, doctor, midwife or ultrasound technician) will ask 
the patient if they are interested in talking with the research assistant and either have 
the RA begin in the room while the patient waits to see the doctor, or give the patient a 
flyer and let them know where to find the RA.  Recruitment, screening and participation 
will occur as detailed below. 
 
Survey Phase 
1.  
The RA will briefly introduce the study and ask the participant if they are 
willing to be screened for eligibility. The RA may use the following script: 
 
 
Hi, Congratulations on your pregnancy! My name is __________; I’m from 
Wayne State University. We are looking for pregnant woman to help with a 
research study. It will take 5-10 minutes to complete.  First off the study is 
completely voluntary. Whether or not you participate will not affect your 
care at the clinic in any way. Also, no information that you give us will be 
shared with any of the staff. It’s completely anonymous, which means your 
name is not recorded anywhere. You also get a gift for your baby for 
participating.  All family members must wait in the waiting room until we’re 
done, and we ask this of everyone that participates.  Does this sound like 
something you’d be interested in?    
 

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If the potential participant agrees, the RA may continue with screening: 
 
Great! The first step is to just ask a couple questions to make sure you are 
eligible (ask age, due date, acceptance of texting, etc.).  Now I can get you 
set up on the tablet. Normally we would go through an information sheet 
together; however, the tablet will read the information sheet to you.  As you 
go along, if you have any questions or concerns please stop and ask me. 
The tablet will then ask you a range of questions related to your health and 
any substances you may or may not use. 
This portion will help determine whether you are eligible for a study; if you 
are eligible, I’ll tell you all about it when you are done.  You can decide then 
if you’re interested.   I will stay in here just in case you have any questions.  
 
 
2.  Begin the Qualtrics screener. Give the participant the tablet and headphones.  
Show them where the volume controls are.  
 
3. 
After the participant is done, Qualtrics provides a message saying “You are all 
done with this screener. Thank you very much for answering these questions! 
Please just give this computer to the research assistant. RA – please press 
continue.” When you press continue you will either see Ineligible or a color. If 
there is a color, they are eligible.  Press continue again to receive their 
Qualtrics ID (it will be a 14 digit alphaneumeric id). Write both the color and ID 
number on the checklist; they will need to be entered into CIAS. 
 
4. If participant is not eligible, RA thanks the participant, gives her a small baby 
gift, information sheet, and moves on.  
 
5. If the participant is eligible and is interested in the RCT, the RA will give the 
participant the informed consent for Clinical Trial. 
 
Thanks so much. We appreciate your help very much. It looks like you are 
eligible the study. This is also completely voluntary; it would take up to 45 
minutes today, and involves a follow-up at the hospital after your baby is 
born. You would receive a $50 Target gift card for participating today and 
up to $75 in gift cards at the follow-up visit. Would you like to hear more?  
 
If “no” say: 
Thanks again for participating in the first part with us. Make sure they know 
how to get where they are going (front desk for next appointment, lab, etc.) 
 
Inclusion Criteria: 

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1.     Is the participant between 18 and 40 years old? 
Yes  
 
  No 
 
* 
 
2.     Does the participant communicate in English?  
Yes  
 
  No 
 
* 
 
3.     Is the participant at 20 weeks gestation or less? 
Yes  
 
  No 
 
* 
 
4.     Does the participant have a cell phone & is she willing to receive text messages? Yes __  No __* 
 
If NO to any of the remaining questions, participant is NOT eligible to participant. 
 
Exclusion Criteria: 
 
1.  
Is the participant enrolled in any studies with the Perinatal Research Branch?  Yes      *  No  
 
2. 
Has the participant been involved in any other research involving Peedy? Yes __*  No__ 
 
If YES to any of the above questions, participant is NOT eligible to participant. 
5.2 Enrollment/Baseline 
 
Participants meeting all eligibility criteria will be offered participation in the pilot clinical 
trial. Those providing written informed consent will again be given the Tablet PC and 
headphones. Participants will then be randomized to one of the five conditions by the 
CIAS software. Total time spent for each participant will be approximately 10-30 
minutes, depending on condition, with the exception of those in the screen only 
condition (who will be done sooner). Randomization will be stratified on race, age, and 
frequency of marijuana use prior to pregnancy. This study will include five conditions 
with an n of 20 per intervention condition (e-SBIRT only, texting only, or combined) and 
10 per control condition (assessment only or screen only). This reduced n for the control 
conditions will simultaneously allow us to (a) focus analyses on feasibility and 
acceptability, given that 75% of participants will receive one or more interventions; (b) 
obtain a full control group for primary analyses, at minimal additional cost/effort, by 
collapsing the two control conditions (if they—as expected—do not differ significantly 
from each other); and (c) pilot the addition of a screen-only control group in order to 
identify any practical or procedural challenges prior to a future Stage II trial.      
 
 
 
 
 

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Table 1. Study arms and associated components  
 
 
Condition 
 
Screening 
Assessment 
battery 
Text 
preferences 
 
eSBIRT 
Tailored 
texting 
1. Screen only control 
x 
 
 
 
 
2. Assessment control 
x 
x 
 
 
 
3. eSBIRT only 
x 
x 
 
x 
 
4. Tailored text only 
x 
x 
x 
 
x 
5. eSBIRT + Tailored text 
x 
x 
x 
x 
x 
 
After determining eligibility by the previously mentioned screening procedures and 
having the participant indicate interest in continuing, the RA reads through the Trial 
consent form.   
 
OK great. Here’s a form describing this second study in detail. Let’s go over it 
together. If you decide you want to participant in this study you will need to sign 2 
copies of this form. You will keep one copy and one copy will be kept in a locked file 
cabinet at WSU in Dr. Ondersma’s office.  
 
Allow the participant time to read, review, and ask questions. Once all questions are answered 
participant must sign 2 copies of the form and answer the quiz to determine they understand the 
study.  
 
Consent Quiz 
 
 
  
 
Correct 
answers 
1.   Is your participation voluntary? _________________________________  Yes 
 
2.   If you decide not to take part in this study, will the care you receive at 
UPG, Thea Bowman, or the DMC be affected? ____________________ 
 
 NO 
3.    How many visits will you be asked to participate in for this study? 
__________________________________________________________ 
 
 2 
4.   When will the second visit occur? _______________________________  after 
delivery
 
 
 
 
 
 
If  participant does not provide correct answer, record the answer and review the consent form. Repeat 
quiz; Questions 1 and 2 must be answered correctly on first or second attempt to continue in the study. 
 
 

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Have participant complete (and RA review): 
 
a) Future Research Contact form 
 
 
Dr. Ondersma often has new studies that you might be interested in; we want to 
know if we can contact you about studies in the future. We would only contact 
you to tell you about a new study. If you’re interested you will go through a 
consent process just like this.  On a separate page is a box for you to check 
telling us whether or not we have your permission to contact you about future 
studies.   
 
b) Contact Form 
 
Once all forms are complete and her questions are answered say: 
 
OK let’s get started. The next part is to use the program on the tablet.  It will 
walk you through it just like before and let you know what group you have been 
put in.  Here are the headphones. If you get stuck, or have any questions, just 
ask me. Ready… 
 
6. Open the tablet to the .mobi site and put in participants first name (spelled correctly), 
the Qualtrics ID (under MISC), and your initials (under staff initials).  Here you will 
need to enter the participant’s phone number in case they are placed in a text 
message group. Please let the participant know that the computer will place them 
into the group and tell them which group they are in.  Since we do not know yet their 
group, you need to put in everyone’s phone number.  They will only get messages if 
they are in a texting group. 
 
Ask them what days of the week and times during the day are okay to receive text 
messages.  The texts will only come during the selected days and times.  Ask them 
the frequency they said on the screener and select from the drop down menu from 
opt-in days (once/week, twice/week, three times/week). 
Also, make sure you select US/Eastern time zone at the bottom. 
 
Press login, write down the CIAD ID and start the program. You will need to re-enter 
the Qualtrics ID number in the text box and select the color.  Then you can hand the 
tablet & headphones to the participant. (Hit next, select full screen). 
 
7. Once the participant is done with the program there will be a screen that says 
“Please give the tablet back to the research assistant” You will press on the button 
that says “For RA only”.  This will take you to a slide that either says “No Text 
Messages” or “Yes Text Messages” 
 
If they receive text messages please say the following. 
“You are in one of the groups where you get text messages. I need to let you know a 
few things before you leave.  We use “smoking” to refer to marijuana use with all of 

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the text messages.  Since we do not know who has access to your phone or how 
much they know about you, we are doing this to provide further protection.  Also, you 
can type “STOP” to the phone number at any point to stop receiving the text 
messages and “START” if you change your mind and want to receive them again.” 
 
8. Once you log out of the program the participant should get a message that says 
“Welcome to the Healthy Parenting Study!” from (313) 444-8802.  Please verify that 
this happens and let Jessi know right away if it doesn’t. 
 
9. At the end of the recruitment process the RA will complete the recruitment log.  
 
HPS Clinical Trial Checklist  
(for use with all participants who agree to screening) 
 
Time started:_______________ 
 
Time end:_______________ 
 
Completed Recruitment log.  
 
_________ 
Participant Questions: 
 
 
 
How far along are you in your pregnancy (must be 20 weeks or less)? 
_________________ 
 
 
Due date? ____________________ 
 
 
 
How long ago did you find out you were pregnant? ______________ 
 
 
 
How old are you? _____________ 
 
 
 
Did you smell cigarette smoke on the participant?   Yes   Maybe    No 
 
 
Did you smell marijuana smoke on the participant?   Yes   Maybe    No 
 
 
Did you smell alcohol on the participant’s breath?   Yes   Maybe    No 
 
_________ 
Qualtrics ID# ________________________ 
 
_________ 
What color did the participant get assigned? __________________ 
 
_________  
Gave participant information sheet.  
 
_________ 
Gave participant baby gift. 

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_________ 
Eligibility for clinical trial (use Eligibility page to determine) 
 
 
 
_________    Read ICF for pilot clinical trial with participant 
 
 
Participant Agreed _____ Yes ______ No 
 
 
Participant passed consent Quiz _______ Yes  ________ No 
 
 
Completed Eligibility & Quiz form _______ Yes  ________ No 
 
Kept a signed copy of ICF _____ Yes ______ No 
 
 
Gave participant a signed copy of ICF _____ Yes ______ No 
 
 
Did participant initial each page of ICF  _____ Yes ______ No 
 
_________ 
Participant Question: 
 
 
 
If we send you text messages how often would you like to receive them and what 
time of day is best for you (go over options in CIAS login page)   
 
_________________________ cell number 
 
_________ 
CIAS/Computer ID Clinical Trial # _____________________ 
 
_________ 
In Clinical Trial package enter your initials in “Staff Initials” and the Qualtrics ID# 
in “Miscellaneous Info.” 
 
_________ 
(If in the text message group) Did the participant receive the welcome text 
message from (313) 444-8802? 
  _____ Yes  _____ No 
 
 
If yes, did you go over details about text messaging? (smoking language, STOP, 
etc.)  _____ Yes  _____ No 
 
_________ 
Gave participant referral guide  _____ Yes  _____ No 
 
_________ 
Distribute Gift card(s) -- participant and RA sign receipt 
 
_________ 
Completed Consent for Future Research Contact 
 

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_________ 
Completed Contact Form 
 
_________ 
Record gift card # 
 
 
 
 
 
$50 (baseline) ________________________ 
 
 
5.3 Follow
-up (Final) Visit 
 
This study is designed to maximize the follow-up rate in what is typically a difficult 
population to track. As part of study consent, we will obtain permission to check each 
participant’s electronic medical records once per day beginning 12 weeks from their due 
date and twice per day beginning 4 weeks before their due date, to determine when 
they have been admitted to the Labor and Delivery Unit of Hutzel Women’s Hospital. 
Checking of medical records will only occur with full approval of the WSU/Detroit 
Medical Center IRB, consent of the participant, and HIPPA authorization from the 
participant. This process will allow us to complete follow-up evaluations with a very high 
proportion of participants without the need for arranging follow-up visits. We have 
successfully used this approach in a different health care system for an ongoing NIAAA 
project involving eSBIRT for alcohol use in pregnancy.  
 
Once we learn of a participant’s admission to the hospital, we will make contact and 
arrange a time to complete follow-up assessment, taking care to insure first that the 
participant has slept, is comfortable, and has not recently been given prescription pain 
medication (within the past 3 hours). All hospital rooms are private. Should medical staff 
require access to the participant, the nurse research assistant will simply pause data 
collection and finish when the participant is again available. The nurse research 
assistant conducting follow-up evaluation will be blind as to the participant’s group 
assignment.     
 
We also try to schedule at a time when family or friends will not be visiting.  If someone 
is staying at the hospital with the participant, we ask if they would mind leaving during 
the visit to assure confidentiality. Participants complete a paper copy of a calendar from 
the past 90 days to fill out any important dates. This calendar is used on the 
computerized version of the Timeline Follow Back interview that asks about any 
marijuana use in the past 90 days.  After that is complete the participant answers 
additional questions (see study measures in Section 3 – Study Design) on the tablet. 
Hair and urine samples are collected during the visit if the participant is willing to provide 
them.  Participants receive a $50 Target gift card for completing the visit and an 
additional $25 Target gift card if they provide biological samples. 
 
 
 

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HPS Clinical Trial Follow-up Checklist  
 
Time started:_______________ 
 
Time end:_______________ 
 
_________    Checked to make sure good time for participant 
 
 
Participant Agreed _____ Yes* ______ No 
 
 
Participant slept since giving birth _____ Yes* ______ No 
 
 
Reporting any distress about birth outcome _____ Yes ______ No* 
 
 
Received narcotic medication within last 3 hours _____ Yes ______ No* 
 
_________ 
Date & time baby born: ____________________________ 
 
_________ 
Baseline CIAS ID ________________  
(enter in MISC in CIAS)  
 
 
 
Baseline date _________________ 
 
_________ 
Qualtrics TLFB ID# _______________________ 
   
 
_________ 
CIAS/Computer ID follow-up # _____________________ 
 
 
 
Entered Baseline number in Misc ______ Yes _____ No 
 
__________ Agreed to give a urine sample _____ Yes ______ No 
 
 
 
_________ Urine Collected (30 mL) 
 
_________ ID number written on sample (use today’s CIAS#) 
 
__________   Agreed to give a hair sample _____ Yes ______ No 
 
 
 
_________ Hair Collected 
 
_________ ID number written on sample (use today’s CIAS#) 
 
_________ 
Gave participant referral guide  _____ Yes  _____ No 
 
_________ 
Distribute Gift card(s) -- participant and RA sign receipt 
 

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_________ 
Record gift card # 
 
 
 
 
 
$50 (follow-up) ________________________ 
 
 
 
$25 (bio sample) ________________________ 

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6 STUDY PROCEDURES /EVALUATIONS 
6.1 Laboratory
 Procedures/Evaluations 
6.1.1 
Clinical Laboratory Evaluations 
Urine Results (Redwood Toxicology) 
Screening Panel testing for: 
Alcohol (Ethanol) 0.04 g/dL; Amphetamines 1000 ng/mL; Barbiturates 200 ng/mL; 
Benzodiazepines 200 ng/mL; Cocaine (Benzoylecgonine) 300 ng/mL; Cotinine (Nicotine 
Metabolite) 250 ng/mL; Opiates 300 ng/mL; THC (Marijuana) 50 ng/mL 
Hair Results (USDTL; United States Drug Testing Laboratories, Inc.) 
All categories confirmed by LC-MS/MS, with Cannabinoids tested first 
AMPHETAMINES 
Amphetamine 100 pg/mg; Methamphetamine 100 pg/mg; MDA 100 pg/mg; MDMA 100 
pg/mg; MDEA 100 pg/mg 
COCAINES 
Benzoylecgonine 50 pg/mg; Norcocaine 50 pg/mg; Cocaine 100 pg/mg; Cocaethylene 
50 pg/mg 
OPIATES 
Morphine 100 pg/mg; Oxymorphone 100 pg/mg; Hydromorphone 100 pg/mg; Codeine 
100 pg/mg; Oxycodone 100 pg/mg; Hydrocodone 100 pg/mg; 6-MAM 100 pg/mg 
PCP 
Phencyclidine 100 pg/mg 
CANNABINOIDS 
Carboxy-THC GC/MS 0.05 pg/mg 
6.1.2 Specimen 
Preparation, Handling, and Storage 
 
 
 

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Urine: 
The following information should be recorded on the bottle label: 
o Date of collection 
o Donor’s identification number 
o Collector’s initials 
Provide the donor with a clean, unused urine specimen collection container and instruct the 
donor to fill the container at least 1/3 full (minimum of 30 mL’s) 
Allow the donor to enter and maintain privacy within the stall or partitioned area 
o Complete the remainder of the test request form while the donor is collecting the 
specimen 
o Urine Drug Screen Type: check the box corresponding to the reason the donor is 
being tested. 
o Security Seal: after collecting the specimen, tighten the bottle cap. Place the 
security seal over the top of the cap and down the sides of the bottle.  
o Specimen Label: Indicate which test or panel is to be ordered by placing a check 
mark in that box. 
o Indicate donor identification number, collection date, and collector, if you have 
not already done so. 
Accept the specimen from the donor, aided by the use of disposable gloves 
 
Hair:  
RA fills out the Custody and Control Form (CCF). Be sure to include the CIAS FU # in Step 1, 
Section B and specify “Research” for Step 1, Section C. Leave Step 2 and 3 blank. Complete 
Step 4. 
Remove the Sample Acquisition Card (SAC). 
o Open it and remove the foil, integrity seal and alcohol pad. 
o Fold the foil in half lengthwise and open. Sign and date the integrity seal. 
o Copy the donor ID# from the CCF to the SAC. 
o Sign the SAC and fill in the date and time. 
o Decide where the hair sample is going to be collected from and check the 
appropriate box on the CCF. 
Collect the hair sample as appropriate: 
o Clean the scissors and hair clip with the alcohol pad. 

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o Select the area where the hair will be collected and note this on the CCF. 
o Grasp a small lock of hair visibly equal to ½ inch wide by 1-2 strands deep when 
held flat across your finger. 
o Cut as close to the scalp as possible, taking the sample from an area on the 
head that is cosmetically undetectable to the donor.  
Put the hair sample in the foil with root ends aligned and pinch it closed. 
Put the sample in the SAC with the root ends to the left. 
Seal the SAC by removing the adhesive strip from FLAP A and folding it over to meet the 
designated spot on the SAC. Repeat this process for FLAP B. 
Complete sealing the SAC by removing the backing from the Integrity Seal and placing it over 
the designated spot on the SAC creating a secure seal across FLAPS A and B. 
Remove the bar code label from the CCF and place it on the SAC in the designated spot. 
6.1.3 Specimen 
Shipment 
Urine samples are shipped within 1-2 days of collection; each sample is logged prior to 
shipment along with location of mailing; hair samples are collected for longer periods of 
time prior to shipment (until 8 samples have been collected) so that bulk mailing can be 
employed as directed by the company; between shipments, hair samples are stored in 
the Project Coordinator’s locked desk drawer. Hair sample identification numbers are 
logged for each shipment. 

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7 ASSESSMENT OF SAFETY 
During recruitment it is explained to the participant that this is a research study. They 
are also told the types of questions that will be asked and that they have the right to 
decline participation or withdrawal at any time. Participants are also explained the 
potential risk of distress due to the sensitive nature of the questions. The participant is 
explained their rights and what the study is clearly and a brief quiz/ questions will be 
asked of them to ensure that the patient understands clearly. Lastly, they are informed 
that a Federal Certification of Confidentiality has been obtained to further protect 
participants against forced disclosure of data.  
 
The IRB determined that the PI’s potential conflict of interest arising from his co-
ownership of the software company which provides the screening, assessment, and 
intervention platforms merited a Data and Safety Monitoring Board and disclosure in 
publications and informed consent forms. As such, amendments were made to the 
informed consent forms to notify participants of this potential conflict of interest prior to 
their enrollment. The DSMB was established to periodically review study progress, any 
noteworthy incidents or adverse events, and participant demographics, among other 
information. The Board is comprised of 3 members. Should any of these members 
believe that an issue requires attention, a meeting will be sought within several weeks to 
provide more information and determine the proper course of action to prevent further 
issues or rectify any that have occurred. 
7.1 
Specification of Safety Parameters 
7.1.1 Unanticipated 
Problems 
The Office for Human Research Protections (OHRP) considers unanticipated problems 
involving risks to subjects or others to include, in general, any incident, experience, or 
outcome that meets all of the following criteria: 
 unexpected in terms of nature, severity, or frequency given (a) the research 
procedures that are described in the protocol-related documents, such as the 
IRB-approved research protocol and informed consent document; and (b) the 
characteristics of the subject population being studied; 
 related or possibly related to participation in the research (“possibly related” 
means there is a reasonable possibility that the incident, experience, or outcome 
may have been caused by the procedures involved in the research); and 
 suggests that the research places subjects or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized. 

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7.1.2 Adverse 
Events 
An adverse event is any untoward or unfavorable medical occurrence in a human 
subject, including any abnormal sign (for example, abnormal physical exam or 
laboratory finding), symptom, or disease, temporally associated with the subject’s 
participation in the research, whether or not considered related to the subject’s 
participation in the research. 
7.1.3 
Serious Adverse Events 
A serious adverse event (SAE) is one that meets one or more of the following criteria: 
 Results in death 
 Is life-threatening (places the subject at immediate risk of death from the event 
as it occurred) 
 Results in inpatient hospitalization or prolongation of existing hospitalization 
 Results in a persistent or significant disability or incapacity 
7.2 Characteristics of an Adverse Event 
7.2.1 
Relationship to Study Intervention 
To assess relationship of an event to study intervention, the following guidelines are 
used: 
1. Related (Possible, Probable, Definite) 
a. The event is known to occur with the study intervention. 
b. There is a temporal relationship between the intervention and event onset. 
c. The event abates when the intervention is discontinued. 
2. Not Related (Unlikely, Not Related) 
a. There is no temporal relationship between the intervention and event 
onset. 
b. An alternate etiology has been established. 
7.2.2 
Expectedness of SAEs 
The Study PI will be responsible for determining whether an SAE is expected or 
unexpected.  An adverse event will be considered unexpected if the nature, severity, or 
frequency of the event is not consistent with the risk information previously described for 
the intervention.   

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7.2.3 
Severity of Event 
The following scale will be used to grade adverse events: 
1. Mild: no intervention required; no impact on activities of daily living (ADL) 
2. Moderate: minimal, local, or non-invasive intervention indicated; moderate impact 
on ADL 
3. Severe: significant symptoms requiring invasive intervention; subject seeks 
medical attention, needs major assistance with ADL 
7.3 Reporting 
Procedures 
 
  
7.3.1 Unanticipated 
Problem Reporting to IRB and NIDA 
Incidents or events that meet the OHRP criteria for unanticipated problems require the 
creation and completion of an unanticipated problem report form.  OHRP recommends 
that investigators include the following information when reporting an adverse event, or 
any other incident, experience, or outcome as an unanticipated problem to the IRB: 
 appropriate identifying information for the research protocol, such as the title, 
investigator’s name, and the IRB project number; 
 a detailed description of the adverse event, incident, experience, or outcome;  
 an explanation of the basis for determining that the adverse event, incident, 
experience, or outcome represents an unanticipated problem;  
 a description of any changes to the protocol or other corrective actions that have 
been taken or are proposed in response to the unanticipated problem. 
To satisfy the requirement for prompt reporting, unanticipated problems will be reported 
using the following timeline:   
 Unanticipated problems that are serious adverse events will be reported to the 
IRB and to NIDA within 1 week of the investigator becoming aware of the event.  
 Any other unanticipated problem will be reported to the IRB and to NIDA within 2 
weeks of the investigator becoming aware of the problem.  
 All unanticipated problems should be reported to appropriate institutional officials 
(as required by an institution’s written reporting procedures), the supporting 
agency head (or designee), and OHRP within one month of the IRB’s receipt of 
the report of the problem from the investigator. 

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7.3.2 
Serious Adverse Event Reporting to NIDA 
 
Procedures and timeline for reporting AEs to NIDA.  
 
AEs will be reported to the NIDA PO at least once per year as a part of the annual 
progress report. These reports will describe the event, when it occurred, the study arm 
of the participant, and the outcome/resolution. If there are no AEs in a given year, the 
report will include a statement to this effect. 
 
Procedures and timeline for reporting SAEs to NIDA.  
 
SAEs, whether or not anticipated, will be reported to the NIDA PO within 24 hours of the 
event by email.  This 24 hour notification will include a brief explanation of the SAE and 
when it occurred.  A written follow up will be sent within 72 hours of the event. This 
written follow up will include information on the date of the event, what occurred, actions 
taken by project staff, planned follow up (if any), the intervention group/study arm of the 
affected participant, whether the event appears to be related to the intervention, and 
whether participant will continue in the study.   
 
Reporting of IRB actions to NIDA.  
 
Follow-up reports to the NIDA program official—made within 48 hours of IRB actions—
will specify IRB actions related to study shut-down or changes. We will follow Wayne 
State University policy in the handling of all AEs and SAEs; see Appendix 1 for 
algorithm from the WSU IRB, which will be followed in all respects except with regard to 
unanticipated SAEs, which will be reported to NIDA.  
 
Wayne State University Risk-Adverse Event Algorithm: 

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8 STUDY OVERSIGHT 
In addition to the PI’s responsibility for oversight, this study will use a DSMB to be consistent 
with a Financial Conflict of Interest (FCOI) management plan from Wayne State University, 
resulting from the PI’s part ownership of the company that markets the software intervention 
authoring tool that will be used in this study. (Other elements of this management plan include 
ensuring that the PI’s grants are never charged for use of the software, disclosing the potential 
COI on all publications and presentations, and noting the potential COI in consent documents.) 
Members of the DSMB assembled for this study include: 
 
i. 
Theresa Winhusen, PhD, University of Cincinnati School of Medicine. Dr. 
Winhusen has conducted multiple NIH-funded clinical trials, many under the 
auspices of NIDA’s Clinical Trials Network, and one of which was a study 
seeking to reduce drug use among pregnant women.  
ii. 
David Ledgerwood, PhD, Wayne State University School of Medicine. Dr. 
Ledgerwood has led or been part of multiple NIH-funded clinical trials for 
smoking or gambling, and as a clinician supervises treatment of opioid-
dependent pregnant women.   
iii. 
Grace Chang, MD, Harvard University Medical School/VA Boston Healthcare 
System. Dr. Chang is a leader in brief intervention trials for alcohol use in 
pregnancy. 
 
Charge of the Board DSMB (e.g., advising PI, sending report to IRB, etc.). The DSMB will 
review all aspects of the study, including recruitment rate, randomization, AEs, protocol 
violations, unexpected events, etc., and will advise the PI in terms of maintaining participant 
safety and confidentiality. They will also be asked to verify that study conduct is not influenced 
by any potential FCOI. They will be asked to approve a report to be sent to the IRB and to 
NIDA. 
 
Statement of no conflicts of interest. All DSMB members will sign a form verifying that they have 
no conflicts of interest with respect to the proposed study. None of the DSMB members are 
involved in any way in carrying out this study.   
 
Frequency of meetings. The DSMB will receive reports and meet at least annually. Additional 
meetings may be called, as needed, to respond to SAEs or any other study-related challenges.   
 
PI acknowledgement of requirement to report DSMB activity as part of Annual Progress Report 
to NIDA. All DSMB activity will be reported to NIDA as part of the annual progress report, as 
required.  
 
In addition to being made aware of possible risks during the informed consent process, 
participants will be protected against these potential risks in a number of ways. As noted in the 
Human Subjects section of this application, we will not collect information about drug use during 
pregnancy (other than for participants in the cross-validation subsample, whose data in this 
regard will be anonymous and unavailable until after the participant has left the hospital). 
Further, we have sought and obtained a Federal Certificate of Confidentiality, and will utilize 
ACASI technology which makes the RA blind as to all participant data. 

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9 STATISTI CAL CONSIDERATIONS 
9.1 Stud
y Hypotheses 
 
Data analysis will seek to (1) verify intervention feasibility and acceptability, (2) obtain 
preliminary efficacy estimates as measured by confirmed self-report (as recommended 
by an expert panel convened by NIDA; Donovan et al., 2012); and (3) also measure 
efficacy in terms of a quantitative measure of drug using days. Details on these three 
analytic elements are provided below. All significance tests will follow standard 
procedures for evaluating distributional assumptions, disproportionate or biased follow-
up, and randomization success, and will utilize transformations and replacement of 
missing data using multiple imputation as appropriate. Manuscripts based on these 
results will be written and submitted during quarter 12 (the end of project year three). 
This work will form the basis of the R01/Stage II study application to follow, unless the 
results suggest that more Stage 1 work is needed before proceeding to a fully powered 
trial. We see the proposed Stage 1 project as a true test of whether these approaches, 
alone or in combination, merit further evaluation.     
 
Feasibility will be demonstrated if a high proportion of participants receive the 
intervention as intended, and acceptability will be demonstrated if participant ratings 
show a high degree of satisfaction and usability. Hypothesis 1a:  90% or more of 
participants assigned to the eSBIRT conditions will successfully complete the 
intervention at the same clinic visit at which they are recruited. Hypothesis 1b:  90% or 
more of participants assigned to the tailored texting conditions will report receiving and 
reading at least five text messages. Hypothesis 1c:  Based on prior standards (e.g., 
Ondersma et al., 2013), we predict that participants assigned to the intervention 
conditions will rate them as highly acceptable, helpful, and easy to use (mean of ≥ 4.5 
on a 1-5 scale ranging from “not at all” to “very much”). 
9.2 
Sample Size Considerations 
Power is neither required nor expected to be adequate in Stage I pilot trials. In an 
exploratory power analysis, we show power of 0.8 to detect a medium to large effect (d 
= 0.69), which we do not expect. We do expect the strongest effects to be between the 
combined intervention and the control group. 
9.3 
Final Analysis Plan 
 
This analysis will make use of two point prevalence outcomes (7-day and 90-day), both 
of which will be dichotomous measures of drug use that will take advantage of the 
windows of detection of the two toxicological measures included in this study. Marijuana 
use in the 7 days prior to follow-up will be defined as either self-report of use in the past 
7 days (per the timeline follow-back interview) or evidence of marijuana use on the urine 
drug screen. Marijuana use in the 90 days prior to follow-up will be defined as self-
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marijuana use per hair analysis. Generalized linear models using a binary logistic link 
function will be used to assess differences in marijuana use between conditions. The 
main predictor will be group membership with 4 levels (collapsing the two control 
conditions, if not significantly different). Control variables will include baseline frequency 
of marijuana use as well as any baseline characteristics not controlled through 
randomization. Hypotheses 2a and 2b:  Trends will favor the intervention conditions on 
confirmed 7-day and 90-day point prevalence, with Logit d effect sizes of at least .30 
(see Hasselblad & Hedges, 1995, for details on Logit d, a Cohen's d analog for 
dichtomous outcomes).  
 
For all efficacy outcomes, we will test interaction terms between baseline characteristics 
(e.g., baseline severity of marijuana use) and group membership to determine if 
baseline characteristics moderate the effects of the intervention. We will also evaluate 
whether treatment-related changes in marijuana use are mediated by changes in 
theoretical mechanisms hypothesized by the TPB or SDT. To assess mediation, the 
above analyses will be run in Mplus; changes in TPB and SDT mechanisms will be 
included as predictors of the outcomes as well as mediators for the effect of the 
intervention. Bootstrapped standard errors will be used to assess the significance of the 
mediation. 
Days of marijuana use in the past 90 days (per timeline follow-back interview) will be the 
third efficacy-related primary outcome of the pilot trial. To assess changes in days of 
marijuana use, generalized linear models using a Poisson loglinear link function will be 
employed. The main predictor in the analyses will be group membership with 4 levels 
(again, collapsing across the two control conditions). Control variables in the analyses 
will include baseline frequency of marijuana use as well as any baseline characteristics 
not controlled by randomization. For these analyses we are also interested in whether 
baseline characteristics moderate intervention effects or if changes in TPB- and SDT-
related constructs mediate the effect. Similar steps as outlined in Section D.c will be 
used to test these moderating and mediating effects. Hypothesis 2c:  Trends will favor 
the intervention conditions on days of use in the past 90 days (timeline follow-back), 
with a Cohen’s d effect size of at least .30. 
Most studies suggest that marijuana’s effects are stronger on later neurobehavioral 
outcomes than on birth outcomes such as birth weight. However, at least two large 
studies (combined N > 19,000) have found marijuana-related effects on birth weight (El 
Marroun et al., 2009; Fergusson, Horwood, & Northstone, 2002). We will use analyses 
similar to those described above in section D.d. to evaluate group-related differences in 
birth weight, length of hospitalization, and days in Neonatal Intensive Care. Results of 
these analyses will be important in informing any potential cost-related elements of the 
subsequent Stage II trial. In additional secondary analyses, we will also examine 
intervention-related effects on help seeking, and will evaluate whether group differences 
in marijuana use—if any—can be partially explained by differences in help seeking, 
especially treatment seeking. Finally, secondary analyses will examine effect size 

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differences for eSBIRT, texting, and combined interventions, and for the screen- vs. 
assessment-only control groups. Regardless of significance, any clear differences (or 
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10 SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS 
Study staff will maintain appropriate medical and research records for this study, in 
compliance with ICH E6, Section 4.9 and regulatory and institutional requirements for 
the protection of confidentiality of subjects.  Study staff will permit authorized 
representatives of NIDA and regulatory agencies to examine (and when required by 
applicable law, to copy) research records for the purposes of quality assurance reviews, 
audits, and evaluation of the study safety, progress and data validity. 
Incentive Storage 
Gift cards are stored in 4 main locations: a safe and a lockbox behind a locked door in 
the Lab, in locked file cabinet drawer in the Lab, and in a locked file cabinet at the Thea 
Bowman clinic (only the PC and 3 RAs have keys to it). Only 3 of each card 
denomination is kept in the file cabinets, to be used if participants are eligible and enroll 
in the study. The RAs move the gift cards to and from the UPG clinic each day there is 
recruitment at that clinic. The lockbox maintains approximately 5 of each card 
denomination for restocking purposes. The safe holds all other cards. Only the Project 
Coordinator has access to the safe, while the PI and PC have access to the lockbox. 
Electronic tracking logs are kept on Dropbox with the location of all gift cards and a 
detailed description of when cards change location (including date and locations 
before/after).  
.   
 

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11 QUALITY CONTROL AND QUALITY ASSURANCE 
The accuracy with which data input matches data output using the software was exhaustively 
checked prior to beginning the trial (using sample protocols).We have never found data coding 
errors on the part of the software in all previous trials. Although no problems are expected given 
past experiences with this technology, any evidence of errors in data recording by the ACASI 
will result in dropping all participants since the last quality check. Data will be checked once per 
month for out of range values and other quality issues. Data from participants collected at 
Hutzel Hospital will be accessible only with appropriate passwords known only to the PI and 
project coordinator. All biological samples will be marked with a unique subject identification 
number only.   
 
The PI, the project manager, and the RA will meet regularly and review all data collection 
procedures, as well as recent data, to ensure that study procedures are being followed 
appropriately and all data are present. 

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12 ETHICS/PROTECTION OF HUMAN SUBJECTS 
12.1 Ethical 
Standard 
 
The investigator will ensure that this study is conducted in full conformity with the 
principles set forth in The Belmont Report: Ethical Principles and Guidelines for the 
Protection of Human Subjects of Research, as drafted by the US National Commission 
for the Protection of Human Subjects of Biomedical and Behavioral Research (April 18, 
1979) and codified in 45 CFR Part 46 and/or the ICH E6.  
 
12.2 Institutional 
Review Board 
 
The Wayne State University Internal Review Board (IRB) oversees research to ensure 
the safe and ethical conduct of human participant research by all faculty, staff, and 
students of WSU. This includes reviews of proposed research, oversight committees, 
continuing oversight for compliance with regulations and policy, quality assurance, and 
education and training for investigators, staff, and committee members. The IRB is 
initially notified of proposed research prior to securement of funding and works with 
investigators to optimize study design, data collection, and associated consents and 
information sheets. After approval of study protocols, any changes must be submitted to 
the IRB via amendments. A yearly continuation is necessary so long as research is 
active; at this time, staff update the IRB of currently approved forms, enrollment figures, 
participant demographics, preliminary results (if applicable), and other pertinent 
information that allows the Board to determine study execution success and participant 
safety and protections. Upon discovering any adverse events, the Coordinator and PI 
are required to file a report with the IRB and perform any suggested response actions. 
Finally, the IRB assists staff in closing the study once data collection has been finalized. 
 
12.3 Informed 
Consent Process 
 
An informed consent information sheet will be utilized for (a) the feedback phases of this 
research, for both pregnant women and medical staff; and (b) as a screening consent 
for the pilot clinical trial.  As noted in 45 CFR 46.117, part 'c:'  "An IRB may waive the 
requirement for the investigator to obtain a signed consent form for some or all subjects 
if it finds…that the only record linking the subject and the research would be the consent 
document and the principal risk would be potential harm resulting from a breach of 
confidentiality." There is no need to record the participant's name in these two aspects 
of this particular study (intervention feedback, and clinical trial screening), and the risk 
from the process of answering questions is less than the potential harm from the 
results of this process being linked to a person’s identity. The participant intervention 
feedback and pilot trial screening informed consent information sheets will be presented 
and reviewed by the Tablet computer. The information sheet for medical staff will be 
presented by a research assistant. The research assistant will review the consent 
document and will offer to read it aloud, and will also check for comprehension. All 

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informed consent information sheets will include all elements necessary for full consent, 
including information regarding requirements, risks, the voluntary nature of the 
research, and the ability to quit at any time. In all cases involving an informed consent 
information sheet, choosing to participate will be considered evidence of having 
consented. Additionally, the Tablet computer-based information sheet will utilize a 
“Check here if you understand and are willing to participate” button. 
 
For the pilot randomized trial, we will utilize written informed consent for those who meet 
all inclusion and exclusion criteria. This consent form will be summarized by the 
research assistant and also read, if the participant wishes; a brief verbal quiz will check 
for understanding, and those failing the quiz twice will not be included in the study. The 
consent form will describe the nature of the two possible interventions, the kinds of 
questions that will be asked, the request for consent to allow limited access to their and 
their child’s electronic medical records, follow-up procedures taking place post-partum 
(including being asked to give urine and hair samples to be tested for marijuana as well 
as cotinine, cocaine, amphetamines, barbiturates, and opiates), the participant’s right to 
decline or quit at any time, and the possibility of distress as a result of some of the 
questions or material. Participants will also be told that their data will be identified by a 
code number only, with the only link between that code and their data being a single 
form kept locked in the PI’s office. We have obtained a Federal Certificate of 
Confidentiality in order to protect participants against forced disclosure of their data; 
participants will be told of this additional protection, presuming our application is 
successful. Finally, although we will not ask any questions that might elicit reportable 
information in these areas, the consent form will clearly note the possible need to 
breach confidentiality should the investigators become aware of reportable information 
regarding child abuse, neglect, suicide risk, or infectious disease. 
 
12.4 
Inclusion of Women and Minorities (Special Populations) 
 
Inclusion of Women 
 
The proposed research is focused exclusively on women in the prenatal and post-
partum period. The sample selected will be representative of this and other urban 
obstetric services. Men will not be included as primary study participants, given the 
focus on prevention of drug use in pregnancy. (However, note that approximately have 
of the 10 medical staff included as focus group members will be men.)  
 
Inclusion of Minorities 
 
Based on the demographics of Detroit, and of previous samples recruited in a similar 
manner from Wayne State University/Detroit Medical Center clinics, it is expected that 
the sample recruited in the proposed research will be primarily composed of racial and 
ethnic minorities. Specifically, we expect approximately 85% of participants to be 
African-Americans, 10% of participants to describe themselves as “Other” or to select 

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multiple racial categories, and 5% of participants to be White; approximately 10% will be 
of Hispanic ethnicity. 
 
This sample, while not generalizable to the entire U.S. population, will be quite similar to 
other samples found in urban health care settings. Such a population, in and of itself, is 
worthy of study given (a) the increased rate of marijuana exposure among children of 
African-American mothers; (b) the clear disparities in the likelihood with which African-
Americans and other minorities receive services related to substance abuse; and (c) the 
confluence of risks to children being delivered in urban hospitals serving low-income 
populations. If the data gathered for this clinical trial justify future research, that 
research will seek to validate technology-based screening and computerized 
intervention with tailored text messages in other samples of women using marijuana 
during pregnancy. 
 
12.5 Subject 
Confidentiality 
 
Subject confidentiality is strictly held in trust by the investigators, study staff, and the 
sponsor(s) and their agents.  This confidentiality is extended to cover testing of 
biological samples and any study information relating to subjects. 
 
The study protocol, documentation, data, and all other information generated will be 
held in strict confidence.  No information concerning the study or the data will be 
released to any unauthorized third party without prior written approval of the sponsor. 
The authorized representatives of the sponsor may inspect all study documents and 
records required to be maintained by the investigator, including but not limited to, 
medical records (office, clinic, or hospital) for the study subjects.  The clinical study site 
will permit access to such records. 
 
Breaches of confidentiality will be prevented in a number of ways. First, we will strictly 
separate identifying information and data, connecting them only via a linking table (with 
a hard copy kept in a locked file cabinet in the PI’s lab, and a password-protected 
electronic version kept on a secure WSU server). Old versions of the paper linking table 
will be shredded; the table will only be accessible by the PI and Project Coordinator. 
Second, breaches will also be prevented by encrypting all ACASI data in transit using 
AES-256 encryption (the highest level possible). Third, breaches will be prevented by 
further protecting saved data with extremely strong passphrases (combining capital 
letters, lowercase letters, and numbers, using at least 12 characters, and changing 
them monthly). Fourth, all study computers will be protected with a very strong 
passphrase.    
 
Should a breach be discovered, it will be reported within 24 hours to the WSU IRB and 
to NIDA officials, followed by a written report within 72 hours. In addition to addressing 

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and correcting the source of the breach, discussions with the IRB, the study DSMB, and 
NIDA will determine whether study participants must be notified of the breach. 
 
Certificate of Confidentiality 
 
To further protect the privacy of study subjects, a Certificate of Confidentiality has been 
obtained from the NIH.  This certificate protects identifiable research information from 
forced disclosure. It allows the investigator and others who have access to research 
records to refuse to disclose identifying information on research participation in any civil, 
civil, criminal, administrative, legislative, or other proceeding, whether at the federal, 
state, or local level. By protecting researchers and institutions from being compelled to 
disclose information that would identify research subjects, Certificates of Confidentiality 
help achieve the research objectives and promote participation in studies by helping 
assure confidentiality and privacy to subjects.  

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13 DATA HANDLING AND RECORD KEEPING 
13.1 
Data Management Responsibilities  
Data collection and accurate documentation are the responsibility of the study staff 
under the supervision of the investigator.  All source documents and laboratory reports 
must be reviewed by the study team and data entry staff, who will ensure that they are 
accurate and complete.  Unanticipated problems and adverse events must be reviewed 
by the investigator or designee.   
13.2 
Data Capture Methods 
 
Most data will be collected using computer-based self-interview (ACASI) technology on 
a Tablet computer, with data being encrypted in transit and stored on a secure server; 
further, all data in the ACASI system will only be identified only with a non-identifying ID 
number for the participant. A single paper copy of the table linking this number to the 
participant’s name will be kept locked in a file cabinet in the PI’s lab, with a password 
protected electronic version stored on a secure WSU server with restricted access, such 
that only the PI and the Project Coordinator will have access to the server and to the 
passwords for the linking table file. The PI’s lab is kept locked, in a locked and alarmed 
secure building on campus.  
 
Three additional sources of data will not be collected directly from the participant using 
the ACASI system. First, data will also be obtained from hair and urine testing 
performed at follow-up. These samples will also be identified only using the non-
identifying participant ID number; the commercial labs doing testing the samples will 
never obtain identifying information on any participant. Further, data from this testing will 
not be available until after the participant has been discharged from the hospital, further 
limiting the potential for any negative consequences relating to prenatal drug exposure. 
Second, data will be obtained by DMC clinic staff from the neonate’s electronic medical 
record (EMR). We will provide this staff person—who will already have access to clinic 
medical records—with the participant’s name and date of birth, the infant’s name and 
date of birth, and other information as needed so that she can accurately identify the 
infant in question. She will record birth weight, length of stay, and number of days in 
neonatal intensive care (if any) on a paper form containing only the participant ID 
number. 
13.3 Data 
Entry 
Data entry for all self-report measures will be completed directly by the participant onto 
a tablet computer using the ACASI software. Data from the two additional sources—
urine and hair data, and EMR data are entered into Excel spreadsheets at the PI’s lab. 
All non-ACASI data are entered by two research assistants separately into identical, 
pre-formatted Excel spreadsheets. The Project Coordinator then combines the entries 

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and uses a simple, pre-formatted row of subtraction cells to verify that all entries are 
identical (yielding a value of zero). Any non-zero values trigger analysis of the source 
data to resolve the discrepancy.  
 
Regarding the ACASI:  the accuracy with which data input matches data output will be 
exhaustively checked prior to beginning the trial, using sample protocols. (Note:  we 
have never found data coding errors on the part of the software in all previous trials.) 
Further, we will test a randomly chosen sample protocol monthly following trial initiation. 
Although no problems are expected given past experiences with this technology, any 
evidence of errors in data recording by the ACASI will result in dropping all participants 
since the last quality check. In addition, data will be checked once per month for out of 
range values and other quality issues. All data will be accessible only with appropriate 
passwords known only to the PI and project coordinator. 
13.4 
Schedule and Content of Reports 
PI, the project manager, and the RA will meet at least monthly while data collection is 
ongoing, to review all data collection procedures, as well as recent data, to ensure that 
study procedures are being followed appropriately and all data are present. 
13.5 Stud
y Records Retention 
Study records will be maintained for at least three years from the date that the grant 
federal financial report (FFR) is submitted to the NIH. 
13.6 Protocol 
Deviations 
A protocol deviation is any noncompliance with the clinical study protocol, Good Clinical 
Practice, or Manual of Procedures requirements.  The noncompliance may be on the 
part of the subject, the investigator, or study staff.  As a result of deviations, corrective 
actions are to be developed by the study staff and implemented promptly. 
These practices are consistent with investigator and sponsor obligations in ICH E6: 
 Compliance with Protocol, Sections 4.5.1, 4.5.2, 4.5.3, and 4.5.4. 
 Quality Assurance and Quality Control, Section 5.1.1 
 Noncompliance, Sections 5.20.1 and 5.20.2. 
All deviations from the protocol must be addressed in study subject source documents 
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14 PUBLICATION/DATA SHARING POLICY 
This study will comply with the NIH Public Access Policy, which ensures that the public 
has access to the published results of NIH funded research. It requires scientists to 
submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital 
archive PubMed Central upon acceptance for publication. 
This study also follows the policy that requires that all clinical trials be registered in a 
public trials registry such as ClinicalTrials.gov, which is sponsored by the National 
Library of Medicine.  The Clinical Trials registration number for this study is 
NCT02191605. 

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Day, N. L., Leech, S. L., & Goldschmidt, L. (2011). The effects of prenatal marijuana exposure 
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