Home Visitation Enhancing Linkages Project (HELP 2.0)
Phase: NA
Conditions: Substance Use
Sponsor: The National Center on Addiction and Substance Abuse at Columbia University

 
 
 
 
Home Visitation Enhancing Linkages Project 
NCT03750487 
 
Study Protocol and Statistical Analysis Plan 
Document Approved: November 2020 
 
 

NOTE: This document contains the study protocol and analysis plan for the originally planned 
pilot RCT. Due to significant delays and recruitment challenges caused by the COVID-19 
pandemic, we were unable to complete the RCT as planned. After review by the DSMB and 
study sponsor, the decision was made to eliminate the randomization and assign all participants 
to the intervention condition to evaluate feasibility and acceptability of the intervention. Of the 14 
enrolled participants, 4 were assigned to the control condition prior to elimination of 
randomization. The remaining 10 participants were assigned to the intervention condition. Due 
to the small sample size, planned longitudinal analyses detailed in this protocol were not able to 
be carried out.  
 
STUDY PURPOSE AND AIMS 
 
 
Substance use (SU) in the perinatal period is a critical public health challenge that is 
highly associated with negative birth outcomes, poor maternal and child health, and increased 
risk for child maltreatment. Rates of SU among pregnant and postpartum women have been on 
the rise, due to the current opioid epidemic. While effective treatments for SU exist, less than 
20% of women who need SU treatment receive it, and this gap is greater for low-income, ethnic 
minority women. Many pregnant and postpartum women conceal their SU and do not seek 
treatment for fear of child removal, significantly increasing risk to themselves and their children. 
 
Home visiting (HV), a strategy for delivering voluntary preventive services aimed at 
optimizing parent and child outcomes across the life course, is the primary supportive 
intervention offered to at-risk families during the perinatal period. HV represents a promising 
venue for addressing SU needs in pregnant and postpartum women for several reasons. First, 
with increased federal support, HV programs have been scaled up nationally, and currently exist 
in all 50 states, the District of Columbia, and five territories, and serve more than 280,000 of the 
nation’s highest risk families annually. Nearly 40% of HV clients report binge drinking or using 
drugs in the 3 months prior to HV enrollment. Second, many HV programs aim to enroll women 
prenatally or shortly after birth, providing an opportunity to intervene early to prevent negative 
outcomes associated with caregiver SU. The immediate postpartum period is a particularly 
important time for preventing SU relapse, and HV often represents vulnerable families’ only 
contact with the formal service system during this time. Finally, pregnancy and the postpartum 
period are times when many women are especially motivated to change behaviors that may 
negatively impact their baby, such as SU. As a voluntary, strength-based program, HV provides 
a natural framework for capitalizing on this motivation to change. 
 
Despite the potential of HV as a venue for addressing maternal SU, there is currently no 
systematic protocol for addressing SU within routine HV, leaving many HV clients with 
undetected and unmet needs that increase maternal and child risk. Screening, Brief 
Intervention, and Referral to Treatment (SBIRT), originally designed to reduce gaps in the 
service continuum from primary care to SU treatment, is strongly supported as a public health 
model for addressing SU. New recommendations for SBIRT in the perinatal period were recently 
published by the CDC, and include universal screening, followed by brief intervention (BI) for 
women at low-to-moderate risk, and referral to specialty SU treatment for those screening as at 
highest risk. This approach has potential as a framework for addressing SU in HV. While HV 
clients comprise the full range of SU risk, the vast majority likely fall in the low-to-moderate 
range, as is common among pregnant and postpartum women in community settings, making 
them good candidates for BIs. Two significant challenges may preclude the successful 
installation of traditional SBIRT procedures into HV. First, HV clients are often reluctant to 
disclose SU to professionals, including home visitors, due to shame, stigma, and fear of child 
removal. Second, most preventive HV models do not provide intensive skills-based training in 
SU for home visitors and do not include standardized protocols for identifying and addressing 
maternal SU. Moreover, most home visitors are paraprofessionals, who lack the advanced 

clinical training and skills needed to effectively deliver evidence-based BIs. To overcome these 
challenges, this study will test an innovative adaptation of the SBIRT framework, SBI-HV, that 
will feature a computerized screening and brief intervention (e-SBI) for SU that has been 
validated in prior studies of pregnant and postpartum women, and adapted for testing in the 
context of home visiting services. The primary advantages of the e-SBI are: (1) it screens for SU 
prior to pregnancy rather than currently, a strategy proven to promote greater openness in 
responding; (2) it is self-administered, allowing women to complete it without disclosing SU to 
home visitors; and (3) it provides a fully-automated BI, precluding the need for home visitors to 
implement complex clinical interventions. The full SBI-HV will include the e-SBI and protocols 
for home visitors to provide facilitation and support to clients. As the e-SBI can be accessed 
remotely, via any internet-enabled device, including a smartphone, clients can access the e-SBI 
independently from their own devices at home. Given the shift to virtual home visiting during the 
COVID-19 pandemic, the e-SBI will be tested as an enhancement to virtual home visiting, and 
completed by clients in between home visits, with facilitation and support provided by home 
visitors during virtual visits. The e-SBI includes two sessions (approximately 20 minutes each) 
focusing on alcohol and drug use (session 1) and co-occurring problems (session 2). The e-SBI 
will be compared to a control intervention that will use the same platform but will provide content 
on nutrition (session 1) and exercise (session 2). Both groups will include home visitor 
facilitation and support before and after e-SBI sessions, as well as technical support provided by 
the study researchers. 
 
The primary study aim is to conduct a pilot randomized controlled trial (RCT) to (1) 
assess feasibility, acceptability, and fidelity of SBI-HV, and (2) determine the preliminary impacts 
of SBI-HV on client symptom reduction (SU, depression, parenting stress), retention in HV, 
engagement in SU treatment, and alliance between the home visitor and client. The pilot RCT 
will be conducted in New Jersey, in counties that are implementing the Healthy Families 
America (HFA) home visiting program. We will enroll 20 home visitors and 40 clients. The pilot 
RCT will be a cluster-randomized trial, with home visitors randomly assigned to study condition. 
Feasibility, acceptability, and fidelity will be assessed via home visitor and client interviews and 
fidelity checklists. Clients will be assessed at baseline, and 3- and 6-month follow-up to track 
SBI-HV impacts on outcomes. 
 
STUDY PARTICIPANTS 
 
 
The study will be conducted within New Jersey (NJ)’s HV system within the Healthy 
Families America (HFA) HV program. Participation will be offered to all HFA home visitors 
throughout the state  
 
Home Visitors 
 
We will enroll 20 HFA home visitors in the trial. Based on our prior research with this 
population, we expect the home visitors to have the following demographic characteristics: 
100% female, average age 36 years, 25% White, 40% Latina, 30% Black, average 5 years HV 
experience, and 60% with greater than a high school education. 
 
Clients 
 
We will enroll 40 clients who meet the following study eligibility criteria: (1) speak English 
or Spanish; (2) age 18 years old or older; (3) pregnant or up to 3 months postpartum; (4) 
enrolled in HFA with a participating home visitor within the prior six months; (5) reporting binge 
drinking or illicit drug use in the 3 months prior to their most recent pregnancy and not currently 
attending substance use treatment; and (6) have access to smartphone or other internet-
enabled device with internet connection. Based on prior work with this population, we expect 
clients to have the following demographic characteristics: 40% Latina, 41% White, 34% Black, 

63% single, 22% with a high school education or less, 78% unemployed, 85% on public 
assistance, and 15% child welfare system-involved.   
 
STUDY CONDITIONS AND HV-SBI COMPONENTS FOR EACH CONDITION 
 
Home visitors will be randomly assigned to Intervention or Control conditions, and clients will be 
assigned to whichever condition their home visitor is in. SBI-HV components that will be added 
on to routine HFA services include (1) electronic screening and brief intervention (e-SBI); (2) 
Home Visitor Facilitation; and (3) Technical Support. Table 1 details which study component 
clients in each condition will receive. The primary difference between conditions will be in the 
content of the e-SBI and home visitor facilitation components. A detailed description of each 
SBI-HV component follows the table. 
 
Table 1. SBI-HV Components by Study Condition 
Intervention Condition 
Control Condition 
Routine HFA Services 
Routine HFA Services 
e-SBI Session 1: Substance Use 
e-SBI Session 2: Co-occurring 
Problems 
e-SBI Session 1: Nutrition 
e-SBI Session 2: Exercise 
Home Visitor Facilitation: 
Introduction and de-brief before 
and after each e-SBI session 
(content related to substance use 
and co-occurring problems) 
Home Visitor Facilitation: 
Introduction and de-brief before 
and after each e-SBI session 
(content related to nutrition and 
exercise) 
Technical support provided by 
research staff 
Technical support provided by 
research staff 
 
Routine HFA Services 
 
HFA is an evidence-based, voluntary, HV program designed to promote positive 
parenting, enhance child health and development, and prevent child maltreatment in at-risk 
families that serves families prenatally up to age 5 years. Home visits (approximately 1 hour 
each) occur weekly for the first 6 months, tapering in frequency over time depending on the 
family’s level of functioning, and follow a structured curriculum. Model implementation follows 
the HFA Best Practice Standards, operationalized through structured program guidelines that 
are flexibly tailored to families’ needs. HFA mandates a quality assurance and accreditation 
process for program sites, thus an infrastructure for fidelity monitoring and CQI is already in 
place. Federally-funded HFA sites are also required to track and report progress on federally-
specified benchmarks. All of the NJ HFA sites are accredited and federally-funded and have 
extensive data tracking and CQI procedures in place. Home visitors and supervisors routinely 
complete logs after each visit and supervision session and data is maintained in an electronic 
Management Information System (MIS) managed by PCANJ.  
 
The HFA national model requires a minimum of a high school diploma plus relevant 
experience for home visitors and a Masters degree or BA with 3 years experience for 
supervisors. Training is required for home visitors (4 days) and supervisors (2 days) at initial hire 
with annual refreshers. In NJ, all HFA training is provided by PCANJ. As required by the HFA 
standards, all full-time home visitors receive 2 hours of individual supervision per week. Per the 
HFA Standards, each supervision session must include administrative (i.e., oversight of program 
policies; adherence to standards), clinical (i.e., discussing families’ challenges; providing 
guidance and coaching; evaluating progress), and reflective (i.e., attending to home visitors’ 
emotional reactions) components.  

 
Families are eligible for enrollment in HFA if they are prenatal or within 2 weeks of the 
baby’s birth, and if they have two or more risk factors associated with child maltreatment (e.g., 
inadequate income, unstable housing, history of substance abuse, no prenatal care, history of 
depression or psychiatric care). Note that these eligibility criteria pertain to enrollment in the 
HFA program and are different from eligibility criteria to enroll in the research study described in 
this protocol (detailed on page 3). Supervisors assign clients to home visitors based on the 
home visitor’s experience and skill, difficulty level of the family, and home visitor’s current 
caseload. Home visitor caseload size is 13-26 families, varying based on the service needs of 
each family. 
 
The HFA Standards specify that home visitors are not therapists and that their role with 
regard to maternal behavioral health needs is to link clients to needed services. Use of 
Motivational Interviewing (MI) strategies is recommended, but programs vary in the extent to 
which MI training and support is provided. HFA provides a manual for working with families in 
acute crisis, but SU is not included in the manual. HFA requires maternal depression screening 
and home visitors are trained in administering screens, talking with families about depression, 
community resources for depression, and stress-reduction activities. SU training is required and 
includes content on: etiology of substance abuse, culture of drug use, strategies for working with 
families with SU, smoking cessation, alcohol use/abuse, fetal alcohol spectrum disorders, street 
drugs, and referral resources. Specific interventions to address SU, beyond providing referrals, 
are not included in the HFA model. 
 
Due to the COVID-19 pandemic, HFA services in New Jersey have moved to a virtual 
model, following guidance from the HFA national model. Virtual home visits are conducted via 
phone or video-conferencing (Zoom or a similar platform), but otherwise are conducted 
according to HFA Standards as described above.  
 
 
Electronic Screening and Brief Intervention (e-SBI) 
 
e-SBI Software and Development 
 
e-SBI content for both conditions was created using Ondersma’s Computerized 
Intervention Authoring System (CIAS), an authoring tool that allows creation or editing of 
computer-delivered interventions without the need of a programmer. Interventions built using 
CIAS are compatible with all mobile platforms, and feature a high-quality synthetic text-to-
speech engine that reads all questions and speaks aloud to the participant; synchronous 
interactivity; natural language reflections; branching logic; a clean user interface; and the ability 
to easily incorporate specific images, graphs, figures, text, or videos. The program is fully 
automated, completed on a touch-screen tablet with headphones for privacy. A 3-D cartoon 
character capable of a range of animated actions (i.e., smile, wave, express concern) narrates 
the e-SBI, reads all items and response choices aloud, and reflects back participant responses. 
The program is designed to maximize interactivity, with immediate responses to participant 
input, occasional summaries, and branching based on participant responses and preferences. 
CIAS has been used with thousands of participants to date, many low-SES, and has 
consistently received extremely high user satisfaction ratings. CIAS can be run on apple and 
android devices, and on tablets and smartphones. 
 
e-SBI Session Features  
 
In both study conditions, e-SBI content is tailored to pregnancy status (pregnant vs. 
postpartum) and in the intervention condition, session 1 content is tailored to the primary 
substance reported by the participant (alcohol, marijuana, opioids, or other drugs). Participants 
will complete the e-SBI sessions in between scheduled home visits, with reminders and 
technical support provided by research staff. The following sections describe the intervention 
content for each session, for the Intervention and Control groups. All sessions for both groups 

include interactivity, branching to specific topics based on selection or responses to questions, 
narration via the 3-D cartoon character, and reflection of responses. All sessions also include 
animated videos providing educational content related to the topic of the session. Each session 
is approximately 20 minutes in length. The purpose of the Control condition e-SBI sessions is to 
control for time and attention associated with e-SBI completion and technical support provision. 
Content was selected to be informative and interesting and potentially useful to the participant, 
but not likely to have an impact on substance use. Nutrition and exercise were selected as 
topics because while these topics are relevant to the home visiting population, they are not 
covered in depth as part of the home visiting curriculum, and thus would be of interest and of 
use to participants.  
 
Intervention Condition Session #1: Substance Use 
 
Session one of the Intervention Condition e-SBI is adapted directly from Ondersma’s 20-
minute interactive e-SBI for alcohol and drug use, which has been tested extensively in 
pregnant and postpartum women in delivery hospitals and OB-GYN clinics. Session one begins 
with Screening for substance use. The Screening section consists of a modified version of the 
Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST), a brief screening tool 
developed by the WHO that evaluates frequency and consequences of SU, and demonstrated 
high sensitivity and specificity and strong validity properties. The ASSIST was modified to ask 
about SU in the three months prior to pregnancy, which has been shown to yield more accurate 
responses with greater sensitivity for identifying active substance users during 
pregnancy/postpartum than asking about current use. Based on their responses on the ASSIST, 
participants will be branched to a brief intervention (BI) that focuses on their primary substance 
(determined based on their highest scoring substance on the ASSIST): alcohol, marijuana, 
opioids, or other illicit drugs. Content in the BI section of the e-SBI will be tailored to primary 
substance and pregnancy status (pregnant or postpartum). The BI applies motivational 
interviewing principles and the FRAMES (Feedback, Responsibility, Advice, Menu of options, 
Empathy, and Self-efficacy) BI framework. The BI begins with a brief video providing 
psychoeducational information about the risks of substance use during pregnancy/postpartum. 
Following the video, participants are asked about their readiness to quit or cut down their 
substance use with the following response options: (a) I have already quit or cut down; (b) I 
would like to quit or cut down right now; (c) I am not sure whether I want to quit or cut down; (d) 
I am not ready to quit or cut down now. BI content is tailored to the participant’s reported level of 
readiness for change and includes the following MI interventions: (1) Personalized Feedback on 
participant-reported negative consequences of SU, readiness to change, and how their SU 
compares to other women; (2) Pros and Cons of SU and behavior change; (3) Menu of Options 
for things they can try that have helped other women change their SU behavior; and (4) 
Optional Goal-Setting regarding changing SU behavior for those who report a desire to make a 
change. Clients who report that they have already quit receive a purely psychoeducational BI. 
Clients who express limited interest in change receive motivational enhancement interventions 
and those desiring change receive goal-setting interventions. Home visiting is featured 
throughout the BI as an important resource, with emphasis on the different ways the home 
visitor can be helpful to participants in dealing with SU concerns. In addition, information about 
local and online resources for obtaining SU treatment or self-help groups (such as AA) is also 
included in the program, so that clients can access that information without the involvement of 
their home visitor. Session one concludes with a video providing a testimonial from a mother 
describing her struggles with SU during pregnancy/postpartum and her success at overcoming 
them. At the end of the session, participants have the option to enter their email address into the 
program and receive a list of all of the resources described in the program (local SU treatment 
providers and online resources).  
 

Intervention Condition Session #2: Co-Occurring Problems 
 
Session two of the Intervention Condition e-SBI is structured similarly to session one, 
and focuses on behavioral health concerns that often co-occur with substance use in pregnant 
women and new mothers: smoking and vaping, depression, and intimate partner violence. 
Participants can choose which of the three topics they are interested in learning more about. 
They have the option to select one, two, or all three of the topics, and also have the option to 
select none of them and exit the session. For each of the three topics, the program is based on 
MI principles and contains the following components: (1) short psychoeducational video; (2) 
brief question about their own experience followed by a reflection; (3) menu of options that have 
been helpful to other women (for example, talking to home visitor); (4) links to resources; (5) 
opportunity to select something from the menu of options that they would like to try; (6) 
reflection on choice. The sessions ends with a brief recap.  
 
Control Condition Session #1: Nutrition 
 
Session one of the Control Condition e-SBI is focused on nutrition for pregnant and 
postpartum women. Content was drawn from First Steps Nutrition Trust, Washington State 
Department of Health First Steps, and Foundations of Maternal and Child Health. Content 
includes: benefits of proper nutrition and healthy eating habits during pregnancy and postpartum 
for both mother and baby; weight gain during pregnancy; recommended nutrients and eating 
habits for pregnancy and postpartum, including while breastfeeding; and advice on reading and 
understanding nutrition labels. Throughout the session, the narrator emphasizes the importance 
of talking to a doctor prior to making any decisions about nutrition or diet. The role of the home 
visitor as a non-judgmental support person who can be helpful is also emphasized.  
 
Control Condition Session #2: Exercise 
 
Session two of the Control Condition e-SBI is focused on exercise and physical activity 
during pregnancy and postpartum. Content was drawn from the March of Dimes and American 
College of Obstetricians and Gynecologists recommendations for physical activity in the 
perinatal period. Content includes: benefits of exercise and physical activity during pregnancy 
and postpartum for mother and baby; recommendations for amount of physical activity during 
pregnancy and postpartum; exercising safely; how to motivate yourself to exercise when you 
may not feel like it; and recommendations for different types of physical activity to engage in at 
different stages of pregnancy and postpartum. Throughout the session, the narrator emphasizes 
the importance of talking to a doctor prior to starting any new exercise program. The role of the 
home visitor as a non-judgmental support person who can be helpful is also emphasized. 
 
Home Visitor Facilitation 
 
We have developed brief home visitor facilitation protocols (5 minutes each) to be 
implemented during the home visits before and after each e-SBI session is completed. All 
protocols were designed in the spirit of the strength-based perspective that underpins HV, and 
aim to leverage the trusting, supportive relationship that is core to effective HV. The goal of the 
facilitation protocols is to support successful integration of the e-SBI within the HV context; they 
are not intended to be therapeutic. Protocols are scripted to aid home visitors in delivery. Note 
that the facilitation protocols will not require clients to disclose SU to the home visitor, though 
they will not be prevented from doing so, and may do so if they wish to. Protocols include 
Introduction to be delivered in the home visit prior to each e-SBI session, and Debriefing to be 
delivered in the home visit following completion of each e-SBI session. The format of each 
protocol is consistent across Intervention and Control conditions, but the content is different, 
reflecting the different e-SBI content depending on study condition.  
 
Technical Support 

 
The Study RAs will provide text- or phone-based technical support to study participants 
as needed. All text and phone communication with participants will be conducted through 
Partnership to End Addiction’s JITAI Master Platform, described in detail below. The Platform 
provides a dedicated study phone number, which will be used for all communication with 
participants. Participants will be sent a personalized link to each e-SBI session via text 
message, which will allow them to click on the link and access the session. If they have trouble, 
they can send a text message to the study number and one of the RAs will respond. They can 
also call the study phone number to reach an RA by phone. RAs will monitor the study number 
(text and phone) daily and will respond within 24 hours to all technical support requests on 
weekdays, and by the next business day if the request comes in on a weekend. Participants will 
also be offered the option to have the RA call them at an agreed upon time and walk them 
through the process of accessing the e-SBI session on their device.  
 
 
TRAINING AND FIDELITY MONITORING 
 
 
Training for home visitors will include a mix of recorded webinars and live trainings over 
zoom. Home visitors will be trained in procedures for referring clients to the study and in 
implementation of the facilitation protocols. Some didactic information on perinatal substance 
use will also be provided, for context. Finally, home visitors will be introduced to the e-SBI so 
that they are familiar with the content their clients will receive. Training will be conducted 
separately for home visitors in each study condition, as the content of the e-SBI and facilitation 
protocols differs by condition.  
 
To monitor home visitor implementation of facilitation protocols (fidelity monitoring), we 
will develop brief fidelity checklists consisting of 1 or 2 items that can be delivered to home 
visitors via text message. For example, after a virtual home visit in which a home visitor is 
expected to deliver the introductory protocol, the home visitor would receive a text message 
asking “Did you deliver the introductory protocol? Text Yes or No.” If the response is “No,” the 
home visitor would receive an additional text message asking for the reason, with a list of 
reasons to select from: “Text 1 if you forgot, Text 2 if the client was not interested, Text 3 if the 
visit was devoted to dealing with a crisis, Text 4 for some other reason.” 
 
RECRUITMENT, ENROLLMENT AND RANDOMIZATION PROCEDURES 
 
 
Home Visitors 
 
The PI will schedule a group zoom meeting for all HFA home visitors in New Jersey’s 
HFA network to introduce the study. Following that meeting, home visitors who are interested in 
possibly participating will be invited to schedule a one-on-one zoom meeting with the PI. During 
the one-on-one meeting, the PI will explain the study in detail and review the informed consent 
form. A pdf version of the informed consent form will be sent to the home visitor via email prior 
to the zoom meeting so that they can follow along as the PI reviews it.  Home visitors will be 
given the opportunity to ask questions about the study and the consent form. Once all questions 
are answered, the PI will ask the home visitor if they would like to make a decision right then 
whether to enroll or if they would like to take some time to think about it. If the home visitor 
would like time to think about it, the PI will call the home visitor back at a later time specified by 
the home visitor. When a home visitor decides to enroll, he/she will sign the pdf version of the 
consent form via DocuSign and then email it back to the PI. The PI will sign via DocuSign as 
well and then email a fully signed copy back to the home visitor for their records. Signing the 
consent form constitutes enrollment into the study. Following enrollment, the PI will use a 
computerized randomization program to randomly assign home visitors to study condition 
(Intervention or Control). 

 
Clients 
 
Clients will be assigned to home visitors according to usual site procedures. Home 
visitors will introduce the study to all clients who meet eligibility criteria (English or Spanish 
speaking; 18 or older; pregnant or within 3 months postpartum; enrolled in HFA within the prior 6 
months) at the enrollment visit (for newly enrolling clients) or at the next available visit (for 
clients already enrolled within the prior six months) using a script provided by study staff. Home 
visitors will ask clients for their permission to provide their contact information to the study team. 
If permission is granted, the home visitor will provide the client’s contact information to a study 
RA, who will contact the client by phone and conduct a brief eligibility screen (data will be 
retained anonymously). Home visitors will also give clients the option to contact the study team 
themselves, if they prefer, rather than having home visitors provide their contact information to 
the study team. If the client is eligible, the study RA will explain the study in more detail and ask 
the client if she is interested in enrolling. If the client says yes, the RA will send the client a link 
to a pdf copy of the informed consent form via email or text (depending on client preference). 
After giving the client a few minutes to review the consent form, the RA will review the main 
points in the consent form and ask the client if she has any questions. After answering all 
questions, the RA will ask the client if she would like to decide now whether or not to enroll, or 
would like to take more time and receive a call back later from the RA. If the client would like 
more time, the RA will call the client back at a time specified by the client. Once the client 
decides to enroll, the RA will ask her to sign the pdf of the consent form using DocuSign and 
send it back to the RA. The RA will then sign as a witness, and send the pdf to the PI for her 
signature, also using DocuSign. After obtaining all signatures, the RA will send a final signed pdf 
of the consent form back to the client for her records.  After the informed consent process is 
complete, the RA will either send the client a link to complete the baseline assessment online 
(via a Qualtrics survey), or schedule an appointment to complete the baseline assessment with 
the client via phone or video-conference, depending on the client’s preference. Signing informed 
consent and completing the baseline assessment constitutes enrollment into the study. Clients 
are assigned to whichever study condition their home visitor is assigned to. 
 
RETENTION STRATEGIES 
 
 
To maximize retention of home visitors, research staff will conduct monthly check-ins via 
Zoom at each study site to provide a forum for home visitors and other staff to ask questions 
about study procedures and express concern with aspects that are not functioning as intended. 
Ongoing contact with home visitors will allow us to address issues of dissatisfaction as they 
arise and we expect this to lead to greater retention. We have used similar procedures in other 
studies. For example, in our prior home visiting study, we retained 21 out of 25 enrolled home 
visitors for the study duration. 
 
To maximize retention of clients, we will apply published strategies that have been 
demonstrated effective in samples of substance using adults, accounting for the high rates of 
mobility that typically characterize this population. These strategies have been applied by Co-I 
Ondersma in many prior studies of low-income pregnant and postpartum women, and have 
yielded follow-up rates ranging from 75% to over 95%. We have also used these strategies in 
several large studies of adolescents and families with substance use and behavior problems, 
and have consistently achieved follow-up rates of over 90% at one-year. Specifically, at the 
baseline interview, we will obtain multiple forms of contact information for clients (phone, cell 
phone, and email). We will maintain contact with clients during the time periods between follow-
up interviews by sending regular texts and/or emails (depending on client preference), with 
reminders about the study and of the next scheduled contact. Follow-up interviews may be 
conducted either online or by phone or video-conference, depending on client preference. If we 

are not able to reach a client directly through these means, we will reach out to home visitors 
and try to connect with clients through them. Additionally, prior to the Baseline interview, the RA 
will explain to clients the specific purposes of the study, the nature of their participation, and the 
timing and content of follow-up interviews, so clients are fully informed and will know when to 
expect to be contacted next. We will also ensure that clients understand that the research study 
is separate from the home visiting program, and that they can continue to participate in the 
research even if they discontinue enrollment in the home visiting program. Information on 
incentives for completing interviews will also be provided. 
 
TIMELINE OF STUDY ACTIVITIES 
 
Timeframe 
Activity 
Person 
Responsible 
Home Visitor Recruitment, Enrollment, and Training [October 2020- 
December 2020] 
 
At Quarterly 
Supervisors’ 
Meeting in 
October 
HELP staff introduce study to HFA supervisors at Quarterly 
Supervisors’ Meeting (via Zoom) 
PI, RAs 
Scheduled for 
Oct-Nov 2020 
HELP staff introduce study to home visitors in NJ HFA 
network (via Zoom) 
PI, RAs 
Home visitors sign informed consent and enroll in study via 
individual Zoom meetings with PI 
PI, RAs 
Home visitors are randomized to condition 
PI 
After home 
visitors enroll 
[Dec 2020] 
Home visitor training [pre-recorded videos plus live zoom 
sessions]-intervention and control groups trained 
separately 
PI, RAs, 
Home visitors 
Client Recruitment and Enrollment [January 2021-October 2021] 
 
At HFA 
enrollment visit 
OR next visit 
after client is 
identified as 
eligible 
Home visitors introduce study (using script) to all clients 
meeting eligibility criteria: newly enrolling or enrolled within 
the last 6 months; speak English or Spanish; 18 years or 
older; pregnant or within 3 months postpartum. 
Home visitors 
Weekly 
Home visitors provide client contact information to HELP 
staff 
Home visitors 
Ongoing 
HELP RAs contact client, conduct eligibility screen, and 
obtain informed consent from eligible clients who are 
interested in participating. 
RAs 
Within 1 week 
of consent 
Client completes baseline assessment [either via Qualtrics 
link or via phone with RA, depending on client preference] 
RAs, Clients 
Upon 
completion of 
baseline 
RA informs home visitor that client has enrolled and 
completed baseline interview and to do Introduction at next 
home visit (content differs by condition) 
RAs 
Implementation of HV-SBI Components [January 2021-December 2021] 
 
At next home 
visit 
Home visitor completes Introduction: Alcohol & Other 
Drugs (for intervention group) OR Introduction: Nutrition 
(for control group)  
Home visitor 
After home visit 
RA sends home visitor text-based fidelity checklist to 
determine whether Introduction was completed 
RAs 

Home visitor completes text-based fidelity checklist 
Home visitor 
Within 2 weeks 
of baseline 
RA prompts client to complete HELP Session 1 (content 
differs by condition) within 2 weeks of baseline date and 
provides technical support by phone or text as needed 
RAs 
Within 2 weeks 
of baseline 
Client completes HELP Session 1  
Clients 
Upon 
completion of 
HELP Session 
1 
RA informs home visitor that client has completed HELP 
Session 1 and to do HELP Debrief 1 AND Introduction to 
session 2 at next home visit (content differs by condition) 
RAs 
At next home 
visit 
Home visitor completes Debrief: Alcohol & Drugs (for 
intervention group) OR Debrief: Nutrition (for control group) 
AND Introduction: Other Concerns (for intervention group) 
OR Introduction: Exercise (for control group) 
Home visitors 
After home visit 
RA sends home visitor text-based fidelity checklist to 
determine whether HELP Debrief 1 was completed 
RAs 
Home visitor completes text-based fidelity checklist 
Home visitors 
Within 2 weeks 
of HELP 
Session 1 
RA prompts client to complete HELP Session 2 (content 
differs by condition) within 2 weeks after completing HELP 
Session 1 and provides tech support by phone or text as 
needed 
RAs 
Within 2 weeks 
of HELP 
Session 1 
Client completes HELP Session 2  
Clients 
Upon 
completion of 
HELP Session 
2 
RA informs home visitor that client has completed HELP 
Session 2 and to do HELP Debrief 2 at next home visit 
(content differs by condition) 
RAs 
At next home 
visit 
Home visitor completes Debrief: Other Concerns (for 
intervention group) OR Debrief: Exercise (for control 
group) 
Home visitors 
After home visit 
RA sends home visitor text-based fidelity checklist to 
determine whether HELP Debrief 2 was completed 
RAs 
Home visitor completes text-based fidelity checklist 
Home visitors 
Follow-Up Interviews [April 2021-March 2022] 
 
After 
completion of 
entire HELP 
intervention 
RA conducts qualitative interviews with home visitors and 
clients (random sample from intervention condition only) 
on zoom. 
RAs, Clients, 
Home visitors 
3 months after 
baseline 
Client completes 3-month follow-up assessment (either via 
online survey or phone, depending on client preference)  
RAs, Clients 
6 months after 
baseline 
Client completes 6-month follow-up assessment (either via 
online survey or phone, depending on client preference)  
RAs, Clients 
 
 
DATA COLLECTION AND TRACKING PROCEDURES 
 
Data Tracking 
 
We will use Partnership to End Addiction’s JITAI Master Platform for tracking participants 
through the study. This platform has previously been used in NIH and foundation research studies 

at Columbia University, New York University, and Northwell Health. The Platform is designed for 
intervention, adaptability, and customization and can be used to manage multiple forms of 
participant contact, including email, text, and phone/voice chat. The platform also accommodates 
linkages to online surveys (such as through Qualtrics) to collect more extensive assessment data. 
The Platform is hosted in HIPAA-compliant Amazon Web Services, with messsaging triggered 
through Twilio, and is managed by Partnership to End Addiction’s staff of content and 
programming experts. 
 
All contacts between study staff and participants will go through the Platform. 
Partnership to End Addiction’s IT department will create a Platform account for the study, with a 
dedicated phone number, that will be accessible only to the PI and study RAs. Upon enrollment 
into the study, home visitors and clients will be instructed to send a text message to the study 
phone number, which will enroll them into the Platform. This will allow study staff to send 
communications via text message. Upon enrollment into the Platform, participants will receive 
an automated message asking them to select preferences for language (English or Spanish) 
and correspondence via text or email (with a prompt to enter their email if selected). 
Communications with home visitors will include (1) reminders to complete study activities; and 
(2) brief fidelity questionnaires as described above. Communications with clients will include (1) 
reminders to complete study activities; and (2) scheduling assessments; and (3) technical 
support requests and responses. Secure links to e-SBI components and online assessments 
will also be sent at the time when clients should complete them. Home visitors and clients can 
also text and/or call the study team to ask questions, reschedule assessments, or request 
technical support. Some messages will be automated (i.e., the welcome and initial introductory 
messages) and others will be generated in real-time by study RAs, using pre-written text to 
ensure consistency in messaging across RAs.   
 
Implementation Data Collection  
 
Qualitative feasibility interviews (approx. 30 minutes) will be conducted via zoom with all 
home visitors and a random sample of 10 clients (balancing on pregnancy status) in the 
intervention condition during the second half of the pilot RCT to assess feasibility and 
acceptability of the SBI-HV. We will randomly select 10 clients to participate in the interview. 
Selection will be random with one exception: we will ensure that the proportion of pregnant 
women in the interview sample of 10 is representative of the proportion of pregnant women in 
the overall sample. Thus, if the overall sample of 20 women in the experimental condition 
includes 8 pregnant women, we will randomly select 6 non-pregnant women and 4 pregnant 
women to participate in the interviews. All interviews will be one-on-one. Clients and home 
visitors will be interviewed separately.   All qualitative interviews will be recorded and 
transcribed, in accordance with gold standard procedures for collection and analysis of 
qualitative interview data. While we prefer that clients and home visitors have their video 
cameras on during the interview to allow for a more natural conversation, clients and home 
visitors will have the option to leave their cameras off and join with audio only if they are more 
comfortable with that. Recordings of qualitative interviews will include audio only, using the 
setting on Zoom that allows for recording of audio only without video. Thus, no recordings will 
include video. If a participant is not comfortable being recorded, they can still participate in the 
interview; the interviewer will take detailed notes on what is said. Clients will also complete a 
series of quantitative rating scales at the end of each e-SBI session assessing user satisfaction. 
Home visitor fidelity will be assessed via brief questions delivered via text message following 
virtual visits in which facilitation protocols are intended to be implemented. Home visitors will 
also be asked to complete a brief Qualtrics survey prior to SBI-HV training to assess 
demographics and readiness to implement evidence-based interventions. 
 
Outcome Data Collection 

 
Client outcome data will be collected at baseline, 3- and 6-month follow-up using 
validated clinical assessment instruments. Assessments will be conducted either via online 
survey using Qualtrics, or via phone or video-conference with the study RA, depending on the 
client’s preference. Video-conference data collection will be done over Zoom and these 
sessions will not be recorded. Assessments will be available in English or Spanish. Each 
assessment will take approximately 40 minutes and clients will receive $25 per interview 
completed. To maximize our follow-up rates, we will obtain multiple forms of contact information 
and contact the home visitor when unable to reach clients directly. Strategies proven effective 
for maximizing honest disclosure of substance use in high-risk populations will be applied, 
including: option for completing the survey online without the RA, a Certificate of Confidentiality, 
and numeric ID codes to link within-client data across timepoints without attaching client 
identifiers to responses. 
 
STUDY MEASURES 
 
Feasibility and Acceptability 
 
Feasibility and acceptability of SBI-HV will be assessed via qualitative interviews with 
home visitors and clients in the intervention condition, designed based on published guidelines 
for assessing feasibility and acceptability of new interventions in field settings. Home visitor 
interviews will assess added burden of the SBI-HV, perceived benefits, and implementation 
barriers. Client interviews will focus on e-SBI satisfaction, barriers to discussing SU with home 
visitors, and the impact of the e-SBI on their HV experience. Following completion of the e-SBI 
sessions, clients will complete several quantitative items assessing different dimensions of user 
satisfaction. Finally, completion rates for each e-SBI session will be used as indicators of 
feasibility.  
 
Home Visitor Measures 
 
Prior to SBI-HV training, home visitors in both conditions will complete a brief 
demographic survey. They will also complete the Evidence-Based Practice Attitude Scale, a 15-
item measure of provider attitudes towards evidence based practices (EPBs), that generates 4 
scales: Appeal of EBPs, Required Use by Organization, Openness to Trying EBPs, Unfavorable 
Attitudes toward EBPs. Consistent factor structure and good internal consistency have been 
shown in diverse provider samples. Home visitors will complete 1-2 item brief fidelity checklists 
after each visit in which a facilitation protocol is intended to be implemented. These items will be 
sent to home visitors via text message and they will respond via text message. 
 
Client Measures 
 
Clients will complete a battery of assessments at baseline, 3-month, and 6-month follow-
up using instruments that have demonstrated strong psychometric properties in similar samples. 
At baseline, we will administer selected sections of the Addiction Severity Index (ASI) to assess 
basic demographics and lifetime and current problems with physical health, employment and 
finances, illegal activity, family relationships, and psychiatric symptoms. Trauma history will be 
assessed at baseline via the Childhood Trauma Questionnaire-Short Form. Primary study 
outcomes (to be assessed at baseline, 3-mo, and 6-mo follow-up) include substance use, 
depression, and parenting stress. Substance use will be assessed via the Timeline Follow Back 
Interview, a calendar-based method for assessing quantity and frequency of SU. Primary SU 
outcomes will include seven-day point-prevalence abstinence rates and monthly reported days 
of use. Depression will be assessed via the Beck Depression Inventory-II, a 21-item scale 
measuring depressive symptoms that is widely used in research and practice with perinatal 
women. Parenting stress will be assessed using the Parenting Stress Index-Short Form, a 36-

item measure of stress associated with parenting that is widely used in longitudinal studies of 
parenting and HV. Secondary study outcomes (assessed at baseline, 3-mo, and 6-mo follow-up) 
include home visiting retention, home visitor-client relationship, substance use treatment 
engagement, child protective services reports, and conversations about substance use during 
home visits. HV retention, CPS reports, and conversations about SU will be mined from the HFA 
MIS. SU Treatment Engagement will be assessed at 6-month follow-up via the Treatment 
Services Review. Additional variables that are potential moderators of impact include: motivation 
to change, intimate partner violence, social support, and stress. Motivation to change substance 
use will be measured with the Maternal Motivation Scale. Intimate partner violence will be 
measured with the Composite Abuse Scale. Social support will be measured with the 
Interpersonal Support Evaluation List (ISEL-12), and stress will be measured with the Perceived 
Stress Scale. All are validated measures that have been widely used in other studies of 
pregnant and postpartum women. The strength of the relationship between home visitors and 
clients will be measured via the Working Alliance Inventory-Short Form, Client Version (WAI-
SC). The WAI-SC is a 12-item measure of client perceptions of trust in their provider and of 
agreement on goals and tasks, and has demonstrated good psychometric properties in the HV 
context. 
 
DATA ANALYSIS 
 
Feasibility, Acceptability, and Fidelity. We will use thematic content analysis to analyze 
qualitative data, an approach that applies inductive coding to identify themes within the data, 
and has been used in other evaluation studies in child welfare, including our prior HV study. 
Audio-recordings of interviews will be transcribed verbatim and transcripts will be coded by two 
independent raters. Final themes will be determined via an iterative process of individual rater 
review and discussion to resolve discrepancies, according to the following steps: (1) 
independent transcript review by each rater to note general themes and highlight key concepts; 
(2) generation of list of lower-level sub-themes and collated statements by each rater 
independently; (3) review of sub-themes by both raters and consensus decisions on final list; (4) 
sorting of sub-themes into higher-level thematic categories by each rater; (5) raters come 
together to agree on final thematic map. Quantitative items assessing client satisfaction with the 
e-SBI will be analyzed using descriptive statistics in SPSS. We will examine descriptive 
statistics for all fidelity checklist items to determine dose of home visitor facilitation received. 
 
SBI-HV Impacts on Client Outcomes. The study will use a randomized intent-to-treat 
design, with home visitors randomly assigned to condition (routine HV vs. HV+SBI-HV). Data 
will have a 3-level nested structure: clients (N=40) within home visitors (N=10-20) within sites. 
Given the small number of home visitors and sites, modeling each as a random effect would not 
yield stable estimates. Therefore, we will use the sandwich variance estimator to adjust 
standard errors as appropriate to account for nesting of clients within home visitors. Site will be 
included as a fixed covariate in all models. We will conduct ANOVA or chi-square tests to assess 
group equivalence on home visitor characteristics (demographics, EBP readiness), and client 
characteristics; those that differ between groups will be included as covariates. We will conduct 
latent growth curve (LGC) modeling in Mplus to examine the impact of study condition on 
change over time in primary and secondary outcomes. Mplus provides full information maximum 
likelihood estimation that produces unbiased parameter estimates under the assumption that 
the data are missing at random (MAR), and outperforms other missing data approaches even 
when MAR is not met. Analyses will use a 2 (study condition) X 3 (time) repeated measures 
intent-to-treat design. First, we will use likelihood ratio difference tests of nested models to 
determine the overall shape of the individual change trajectories: no change or linear change. 
Next, we will test unconditional models for all outcomes to obtain the average change effect. 
Third, we will add study condition to test its impact on initial status and change over time. Model 

fit will be evaluated via chi-square, RMSEA, CFI, and TLI, and condition effects will be 
demonstrated by a statistically significant slope parameter, as tested by the pseudo z test, 
associated with study condition. For normally distributed outcomes, we will use conventional 
LGC models, with the appropriate estimator selected based on the distributional properties of 
the DVs. If client outcomes deviate substantially from normality, we will apply a negative 
binomial estimator, as recommended for count outcomes (i.e., days of SU) with a distribution 
that is skewed toward zero. Effect size estimates using Cohen’s d will be calculated for all 
condition effects on client outcomes based on published LGC model recommendations. 
 
The LGC modeling described above is our preferred approach for analysis. However, 
given our small sample, we present an alternative analytic strategy in case the longitudinal 
models fail to converge. If this occurs, we will conduct a series of ANOVAs to test the difference 
between study conditions on client outcomes separately at each follow-up time point (3- and 6-
month), including the baseline value of the outcome as a covariate. Effect sizes will be 
calculated using Cohen’s d.  
 
Exploratory post-hoc analyses using the methods described above will be conducted to 
examine: (1) condition differences in home visitor-client alliance; and (2) differences in SBI-HV 
impact based on pregnancy status.