**1. Introduction**

Prenatal consumption of alcohol and drugs continues to be a major health, social, and public policy issue in Canada [1,2]. Indeed, surveys have found that upward of 11% of women report consuming alcohol and between 1% and 5% reported using street drugs during pregnancy; both rates are considered to be underestimates given the inherent risks and stigma that go hand in hand with revealing prenatal consumption of alcohol and other substances. As well, a large percentage of the women who use substances prenatally are polysubstance users [3], with one report stating that the rate of (prenatal) poly substance "is as high as 50% in some studies" [4].

Women's reasons for prenatal substance use are both complex and gendered. Research suggests that women's prenatal substance use is often driven by a host of social determinants of health factors such as deep poverty, a history of physical or sexual abuse and neglect or other forms of trauma, intimate partner violence, mental health concerns, precarious living conditions including homelessness, child welfare involvement including maternal–child separation, and physical health problems [5–8]. Moreover, women who are struggling with substance use are typically isolated, are more likely to be living with a partner with problematic substance use, experience lower levels of social support, and have fewer resources at their disposal relative to their male counterparts [1,7,9]. These factors contribute to women's reluctance to reveal the full extent of their substance use [3].

Systemic barriers compound the situation as standard systems of care often don't meet the needs of women with prenatal or postnatal substance use issues, especially not women trying to raise children. Indeed, substance use and child protection services tend to operate in discrete silos with their own distinct goals, policies, expectations, and legislative responsibilities that in the past have resulted in high rates of child apprehensions from families wherein parental alcohol and drug use is a factor [10–14].

As a result, when seeking help for their substance use, vulnerable, marginalized women commonly experience numerous barriers including: stigmatization, lack of mental health supports, negative attitudes of health care providers, and adversarial approach of child welfare authorities [1,9,10,15]. Not surprisingly, fear of child welfare authorities is another factor in women's avoidance of services, as is inadequate transportation and/or lack of child care [16]. These factors together make the decision to seek addiction treatment and support services by vulnerable, pregnant, and early parenting and substance using women all the more challenging. For service providers this also makes it all the more important that the programs they offer meet women's needs [7,17–19].

Despite these hurdles, for many vulnerable women, pregnancy is a time of increased motivation to contemplate significant life changes, particularly prompted by women's desire to keep their newborn in their care [20]. Indeed, the research literature suggests that women will respond to prevention services that are aimed at improving their health, including efforts to decrease or stop substance use or to increase their safer use of substances [19–21]. There also is strong evidence that outcomes for mothers and infants improve when accessible, women-centered substance use services or treatment are offered in conjunction with prenatal care [2,9,19,22]; moreover, care that is also tailored to the specific and evolving needs of women, their children, and the mother–child dyad is viewed as the most effective [12]. Programs that integrate practical and social supports with prenatal and postnatal health services, such as culture, transportation, child care, and meals, and that address the fear of child apprehensions may have an advantage in terms of engaging women who otherwise have few reasons to trust the formal health care system [23]. Moreover, programs that use non-judgmental, relationship-based, trauma-informed, and harm reduction approaches and that acknowledge women's unique realities when it comes to the mother–child relationship have been found to be most effective in reaching vulnerable pregnant and parenting women with substance use issues [8,15,19,24,25].

Research indicates that many women who use substances during pregnancy are polysubstance-using [3,4]; further, once they engage with supportive services, they tend to be selective with respect to which substances they continue to use throughout pregnancy and which they reduce or stop using altogether [3]. In addition, women are inclined to underreport their substance use until they have built a relationship with their service provider that helps them to feel safe enough to disclose the full extent of their use [13]. Hence, community-based programs that have been leaders in the field of fetal alcohol spectrum disorder (FASD) prevention in Canada focus on problematic substance use more broadly, within the context of a social determinants of health context and women's lived experiences as a way of engaging very vulnerable women without further stigmatizing them for their choices [22]. In keeping with this practice approach, in this study, "problematic substance use" is defined as the use of substances, including alcohol, that result in negative consequences in a person's

daily life, including adverse health consequences [26], as well as "social, financial, psychological, physical, or legal problems as a result of the drug use" [27].

Despite the evidence that exists with respect to promising approaches, further study would help to enhance our understanding of their implementation in community settings, including a better understanding of what motivates clients to seek services and supports as well as their perspectives on what changed the most in their lives as a result of their involvement in the service(s). To address this, a multi-site evaluation of "wrap-around" FASD prevention programs serving women at risk was envisaged.

#### *Co-Creating Evidence Evaluation Study*

In keeping with the internationally recognized four-part FASD prevention model [28], women at highest risk of having an infant with prenatal alcohol exposure are those who who have substance use, mental health, and/or trauma-related issues and/or related social or financial concerns; "Level 3" FASD prevention programs offer holistic, multi-service programming to these women in ways that are specialized, culturally safe, and accessible. The Co-creating Evidence project, a multi-site three-year evaluation of eight different holistic wrap-around programs serving highly vulnerable women at high risk of having an infant with prenatal substance exposure and/or affected by FASD is the first of its kind in Canada. Funded by the Public Health Agency of Canada, the study runs from 2017 to 2020 and brings together many of Canada's multi-service prevention programs with the aim of: sharing knowledge of their practices; demonstrating the effectiveness of prevention programming serving women with substance use and complex issues; and identifying characteristics that make these programs successful. The eight program sites volunteered to be part of the study.

Summary descriptions of the programs taking part in the study are provided in Box 1. The seventh program specifically serves pregnant or early parenting women who have substance use issues and/or other complex challenges. The eighth program serves women who are at risk by virtue of being young, i.e., 16 to 24 years of age; while problematic substance use may be an issue, it is not the program's primary focus. Nevertheless, given the region's very limited availability of substance use services, it is an issue that comes up with regularity. While the programs taking part in the co-creating evidence study are doing FASD prevention work, because they approach women's issues holistically and employ a social determinants of health lens, the programs typically do not depict themselves as FASD prevention programs. At the same time, staff at all programs have training in FASD and trauma-informed practice (as well as other types of training) and also are members of a national FASD prevention research network. All of the programs have a mandate to support healthy birth outcomes, including helping to reduce the likelihood of FASD.

## **Box 1.** Capsule descriptions of co-creating evidence study's program sites.

**HerWay Home (Victoria BC)** offers drop-in and outreach support, on-site wellness and prenatal/post-natal groups as well as other health/medical services for women and their children, through a combination of program staff and in-kind support from the Island Health Authority. Women can participate in HWH until their child is approximately three years old.

**Sheway** (**Vancouver BC**) is a partnership between Vancouver Coastal Health Authority, Ministry for Children and Family Development, Vancouver Native Health Society and the YWCA of Vancouver. A range of on-site health and social services is offered on the first floor; an on-site health clinic is on the second floor; and child care and housing operated by the YWCA is on the third floor. Voluntary child welfare services are provided on-site through a partnership agreement with the provincial Ministry. The length of time that women can participate in Sheway is flexible and not set by the child's age.

**Maxxine Wright (Surrey BC)** offers health and social supports through co-location with Atira Women's Resource Society, which operates transition housing and second stage housing on-site. Atira offers most of the social programming, with participation from Fraser Health. Health/medical care is provided by Fraser Health. Child welfare and income assistance services are provided on-site through a partnership agreement with relevant provincial Ministries. Women can participate in MW until their child enters school.

**Healthy, Empowered, and Resilient (Edmonton AB)** is located within the Boyle Street Community Services, which provides an array of social, mental health, family, and cultural services in Edmonton's downtown core. H.E.R. provides outreach to highly street-involved clients; through its staffing and partnership with Boyle McCauley Health Centre, H.E.R. clients have access to prenatal care and post-natal support. Women can participate in H.E.R. until six months post-partum.

**Raising Hope (Regina SK)** is a residential program located in an 18-unit apartment building (purchased by a non-profit housing society for the program's exclusive use). A range of health/medical, social/cultural supports and programming including child care is offered on-site; residents are required to take part in daily programming. Women and their children can stay for 18 months.

**The Mothering Project (Winnipeg MB)** is a program of Mt Carmel Clinic and is co-located with the clinic. Through its staffing and partnerships, the MP offers a broad range of drop-in, outreach, and on-site supports and health/medical services along with a dedicated space for cultural ceremony. A licensed day care is co-located with MP with spaces set aside for program clients. Women can participate in the MP until their child reaches the age of five.

**Breaking the Cycle (Toronto ON)** is one of the first FASD prevention programs in Canada. The program provides children's developmental assessment and mental health services with wrap-around services for women. Each woman is connected to a counsellor and each child is connected to a Child Development Worker. Women can participate in BTC until their child is six years old.

**Baby Basics (New Glasgow NS)** is a weekly drop-in parenting program operated by Kids First Family Resource Program, for women under age 25 and their children age 0–6. Although not specifically directed at women who are using substances, there are very few such options available to women in the region. BB offers a safe place for women to access support and talk about a range of issues. Women can participate in BB until their infant is one year old.

A previous article [29] described the study overall, with an emphasis on presenting: an overall theory of change for the programs; the services, activities and common components offered by the eight programs; women's situations at intake; and interim qualitative findings regarding what clients like best about their program. This article shares additional interim findings from the study, based on data gathered between April and December 2018. In this article we focus on:


#### **2. Materials and Methods**

#### *2.1. Study Design*

The co-creating evidence study is employing a mixed-methods design, guided by principles of collaboration and partnership. The study is guided by collaborative and participatory principles [30], including the principles of "fostering meaningful relationships" (with program staff and stakeholders), "developing a shared understanding of the program," "promoting appropriate participatory processes," and "promoting evaluative thinking" [31,32]. In June 2017, the project team convened an introductory face-to-face meeting with program leaders to create a theory of change and the theoretical/philosophical foundations, approaches, activities, and anticipated outcomes of the programs collectively. Since that time, bi-monthly web-based teleconferences have been held to discuss key issues related to data collection and analysis, and to solicit the program managers' feedback regarding interim project findings, draft reports, and knowledge translation. These meetings also provided the program leaders with opportunities to exchange information about their practices, shared issues, common understandings, programming shifts, and contextual issues of significance such as the ongoing opioid crisis. In addition, a National Advisory Committee was established at the beginning of the study, comprised of people with expertise in policy, programming, research and evaluation related to FASD. The Advisory Committee meets about 2–3 times a year.

#### *2.2. Data Collection Processes and Instruments*

Data are gathered through two separate processes:


This article focuses on the qualitative interviews conducted with clients/participants during the first site visits between April and July 2018 and questionnaire data collected as part of the interview process. It is supplemented with interview data with staff and program managers/leaders.

#### *2.3. On-site Data Collection by Project Team*

The project team conducted individual qualitative interviews with clients, using an interview guide that was created for this project. Interview questions include: how the woman first learned about the program; what she hoped to get out of her involvement with the program; her life situation just prior to becoming involved with the program; her satisfaction with the program (e.g., what she liked most about the program, didn't like, and would change); and what was most important to her about the program. As well, the interview contained open-ended questions pertaining to the client's use of the program's various services and activities. Clients were also asked about perceived impacts of the program. A modified version of the most significant change (MSC) technique was employed [33]; informants are asked to share what was "the most significant change that happened" as a result of the program. The MSC technique was modified in this study in that the analysis of clients' stories did not involve formal review by external stakeholders or hierarchical selection and quantification of the stories.. The interviews were conducted in a private office, using a guided conversation approach that enabled interviewees to speak freely about which was most important to them.

After the interview, women were invited to complete the client questionnaire, which most often was administered verbally by the project team member, but which the participant could complete on her own if she preferred. The client questionnaire utilized a five-point Likert-type scale and focused both on participants' experiences with their program (e.g., sense of physical safety and emotional safety; being respected; being a partner in planning and having a voice in decision-making; feeling that staff are sensitive when asking about difficult experiences, and so forth), and their perspectives on program impacts and how helpful the program had been in relation to outcomes in various facets of their life (e.g., in relation to accessing safe housing, accessing prenatal/postnatal care, and having a healthy birth, keeping or regaining their child(ren) in their care, and quitting or reducing their substance use). The questionnaire was created specifically for this study; at the same time, it included standardized questionnaire items that have been used in evaluations of trauma-informed and/or harm reduction focused programs [34].

All participants were provided with an honorarium (\$25) for completing the interview and questionnaire. Program staff were available afterwards should clients have questions, comments, or concerns regarding the interview. Prior to launching the formal data collection, the project team pilot tested the interview guides and interview process with four sites. The purpose was to garner feedback from clients and staff regarding the process and the questions including how clients felt about answering potentially difficult questions about their lives.

## *2.4. Participants and Sampling Approach*

Eligibility criteria for client participation in the interview and questionnaire were as follows: (a) the woman had to be accessing services from the program in the month of data collection; (b) women were 16 years or older; and, (c) women were English-speaking. Recruitment was handled by program staff who, approximately one month prior to the site visit, posted notices in program space regarding the interviews and made announcements during group and/or drop-in programming, inviting clients to come to the program for an interview or otherwise express their desire to do the interview off-site. Both forms of recruitment reinforced that the interviews were confidential and anonymous. For clients, a voluntary sampling approach was employed as program coordinators and the research team thought it was important for all clients who wanted to take part in an interview and who were available during the team's site visit to be able to do so. At the same time, program staff did not formally track the number of clients whom they told about the site visit and interview opportunity, nor did they keep track of the number of clients who expressed disinterest in doing an interview; thus, it was not possible to know how many, if any, clients refused to participate in the in-person data collection process. A nominated sampling approach was used to create the sample of service partners; program staff at all sites provided the researchers with contact information for each program's closest service partners.

A total of 125 program participants/clients (of whom 123 completed the client questionnaire) took part in an in-person interview between April and July 2018. The number of interviews with clients varied across sites, from *n* = 32 at one of the largest sites to *n* = 8 at two sites; there were three sites at which more than 20 clients were interviewed and five sites at which 8–11 women were interviewed. Differences in terms of the number of interviews conducted per site reflect the size and scale of the programs and was roughly proportional to the number of clients per site. As well, events outside of the program, including crises in the community and/or in clients' lives also impacted response to the invitation to take part in the study.

All of the program participants identified their gender as female, and more than half were older than 30 years old (see Table 1). Every participant who completed the client questionnaire completed the demographic questions. Most often women self-identified their cultural background as Indigenous, followed by European/White. The length of time women had participated in the programs varied from less than one month to more than three years. Some of this variation is due to the policies of the individual program; for example, no participants from HER had participated in the program for more than one year as the discharge from the program occurs at six months post-partum.

#### *2.5. Data Analysis*

A frequency analysis of the client questionnaire was conducted in SPSS 26 (SPSS Inc., Chicago, IL, USA) to describe the participants. Missing data for each question ranged from *n* = 0 to *n* = 45, and percentages reported in the results did not include the women who did not answer each question in the denominator.


**Table 1.** Characteristics of client questionnaire participants.

As the interviews with clients, staff and service partners involved open-ended questions, qualitative data analysis techniques were used, and qualitative data analysis software (NVivo12) (QRS International, Melbourne, Australia) was utilized to facilitate the analyses. In keeping with these techniques, written transcripts from all interviews were read multiple times by the researchers to begin the process of identifying themes and analytic ideas. Initially, each researcher coded the transcripts separately and identified preliminary themes inductively. The three researchers involved in carrying out the interviews highlighted naturally occurring patterns in the data, including words, phrases, or ideas most commonly voiced by participants, which formed the basis of the thematic analysis [35,36]. As means to strengthen the study's rigor, the project team engaged in numerous discussions wherein they presented and reviewed one another's emerging reflections, insights, and ideas about the data. Any differences in the researchers' interpretations were resolved through discussion, review of the supportive textual evidence for each theme, knowledge of and comparisons with findings from the literature and previous relevant research, and consensus decision-making. Themes were ranked in strength based on a combination of the frequency with which they emerged and the intensity with which the speakers voiced the theme as evidenced by repetition of the theme/idea within the same utterance and/or the speaker's emphasis or tone of voice when speaking, which was recorded by the researchers in their interview transcripts.

#### *2.6. Ethics Approval*

The evaluation study received ethics approval from the University of British Columbia Office of Research Ethics (H17-02168), Fraser Health Authority, Vancouver Coastal Health Authority, Island Health Authority, and York University. Study participants provided informed consent to participate in the interviews. All study participants were competent to provide their own informed consent and all were over age 18.

#### **3. Results**

#### *3.1. Overview of the Programs' Services*

Drawing on interviews with staff and program leaders/managers and written program descriptions, Table 2 shows that, through a combination of their own staff or staff from partner organizations providing services on site, all co-creating evidence programs offer a mix of accessible health and social services and supports aimed at meeting clients' holistic health, social, cultural, and practical

needs. The programs' core philosophical pillars include being relationship-based, trauma-informed, women-centered, culturally-informed, and employing non-stigmatizing harm reduction approaches. Many services were offered in group format, though nearly all programs offered one-to-one services as well. Programs connected to a health authority were more likely to offer health services on site (e.g., public health nurse, physician, nurse practitioner, or midwife).


**Table 2.** Services/activities offered by programs via staff or service partners or via referrals.
