The postpartum period is a time of significant risk for substance use (SU), as more than half of women who reduce their SU during pregnancy return to pre-pregnancy levels within 3 months postpartum, due to hormonal changes, the stress of caring for a newborn, sleep deprivation, and social isolation. Postpartum SU may increase risk for child maltreatment, which can have devastating impacts on brain development, leading to long-term impairment. Effective treatments for SU exist, but are often not accessed by postpartum mothers due to stigma and fear of child removal. Brief interventions delivered during the early postpartum period may prevent postpartum escalation of SU, but often do not reach those at highest risk, and when they do, effects are short-lived. There is a critical need to determine the most effective approaches for reaching high-risk new mothers to provide evidence-based interventions to prevent postpartum SU.
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 in the United States. As HV is often one of the only service touchpoints for vulnerable families during the postpartum period, it is a promising venue for reaching new mothers to prevent risks associated with SU. However, the most widely used HV models do not have standardized protocols for identifying and addressing SU risk, beyond making referrals to community based services, which leaves many mothers with unaddressed SU concerns that put themselves and their babies at risk. The investigative team has been working to fill this significant gap in services since 2013, and this study represents the next phase of this work, ultimately aimed at providing the HV field with a feasible and effective tool for managing perinatal SU and reducing associated risks to families.
Screening, Brief Intervention, and Referral to Treatment (SBIRT), originally designed to reduce gaps in the service continuum from primary care to SU treatment, has been widely recommended as a public health model for addressing SU. This approach may be a good fit for the HV context given its non-judgmental nature, the prevalence of low-to-moderate risk among HV clients, and the small proportion of HV clients who are actively seeking SU treatment. Two key challenges preclude the successful integration of traditional SBIRT procedures into HV. First, HV clients are often reluctant to disclose SU to professionals, including HVrs, due to shame, stigma, denial, and fear of child removal. Second, most HVrs are lay professionals, who lack the advanced clinical training and skills needed to effectively deliver evidence-based brief interventions (BI).
Screening and Brief Intervention (SBI) that is delivered digitally via computer or smartphone has great potential to overcome both of these challenges, as it does not require clients to directly disclose SU to a provider or providers to deliver evidence-based BIs. Digital SBI has been proven accessible and highly acceptable in postpartum mothers when delivered in healthcare settings, but shows small and inconsistent effects. The BI literature suggests that extended intervention contacts may bolster BI effects. Additional digital BI sessions and automated text messages are potential methods of extending BI impacts, and both have demonstrated acceptability in postpartum mothers. In a prior study, the investigative team developed an innovative digital SBI model that was tailored to the HV context (SBI-HV) that included an electronic SBI (e-SBI) that clients completed on their smartphones in between home visits, and a home visitor facilitation component to promote integration of the e-SBI into routine HV. The e-SBI applied motivational interviewing (MI) principles and the Feedback, Responsibility, Advice, Menu Options, Empathy, and Self-Efficacy BI framework. Confidentiality and preserving clients' choice regarding disclosing SU to their home visitor is core to SBI-HV. A small pilot study supported initial feasibility and acceptability of SBI-HV. Building on the prior R34, the proposed study aims to further optimize the SBI-HV by applying a factorial design to compare preliminary impacts of three SBI-HV delivery strategies: a single e-SBI session (main e-SBI), the main e-SBI session plus a booster session (booster e-SBI), and 4 weeks of tailored text messaging following e-SBI (text messaging). Additionally, this study will systematically assess implementation facilitators and barriers to inform development of targeted implementation strategies to support sustainable integration of SBI-HV into routine HV.
The proposed R34 will use a Type 1 hybrid implementation-effectiveness design with a pilot 3X2 factorial trial and apply the RE-AIM and PRISM implementation frameworks to achieve the following specific aims:
1. Test the impact of 3 SBI-HV delivery strategies (main e-SBI; main e-SBI + booster e-SBI; and text messaging) on postpartum SU, maternal self-efficacy, motivation to avoid SU, and HV retention.
2. Evaluate feasibility, acceptability, fidelity, and facilitators and barriers to the 3 SBI-HV delivery strategies.
3. Develop tailored implementation strategies to support SBI-HV integration into routine HV.
The investigative team will partner with the Kansas Healthy Families (HF) multi-site HV system to complete study aims in 3 phases. All phases will be guided by the RE-AIM and PRISM implementation frameworks.
Phase 1: Pre-Implementation (Months 1-6): This phase will include a mixed-methods assessment of PRISM domains to inform SBI-HV implementation. Participants will include 36 home visitors, 36 clients, 12 supervisors, and 12 administrative staff representing all 12 Kansas HF programs. During this phase, program capacity and readiness to implement SBI-HV will be assessed with the following goals: (a) select implementation program sites; (b) promote buy-in from key program staff; and (c) inform local adaptations to the SBI-HV.
Phase 2: Implementation (Months 7-25): This phase will include a pilot 3X2 factorial trial with 120 clients and 20 home visitors at 5 sites to obtain proof-of-concept data on the individual and combined impacts of the SBI-HV delivery strategies (main e-SBI, main e-SBI + booster, and text messaging) on SU, motivation, self-efficacy, and HV retention, as well as quantitative data on the RE-AIM domains.
Phase 3: Post-Implementation (Months 26-36): This phase will include qualitative interviews with home visitors, clients, supervisors, and administrative staff who participated in the factorial trial to systematically assess implementation facilitators and barriers using the RE-AIM and PRISM frameworks. This phase will also include an iterative stakeholder-engaged process of developing candidate implementation strategies for testing in a future study.
