N/A
Completed N=14
Home Visitation Enhancing Linkages Project
Source: ClinicalTrials.gov NCT03750487 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
May 2024
Primary outcomePrimary: Feasibility: e-SBI Session 1 Completion Rate — 8; 4; 2; 0 Participants
Summary
A small pilot randomized controlled trial (RCT) will be conducted to test the impact of an electronic screening and brief intervention (e-SBI) on reduction in substance use (measured via self-report), associated symptoms (depression and parenting stress), and improvement in home visiting retention and substance use treatment engagement. While a pilot RCT was originally planned, the study experienced significant delays and recruitment challenges due to the COVID-19 pandemic. Therefore, 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility: e-SBI Session 1 Completion Rate |
8; 4; 2; 0 | — |
| PRIMARY Acceptability: Satisfaction With e-SBI Session 1 (Intervention Group Only) |
4.03 | — |
| PRIMARY Feasibility: e-SBI Session 2 Completion Rate |
7; 4; 3; 0 | — |
| PRIMARY Acceptability: Satisfaction With e-SBI Session 2 (Intervention Group Only) |
3.93 | — |
Eligibility Criteria
Inclusion Criteria
- English-speaking,
- 18 years or older,
- pregnant or up to 3 months postpartum,
- newly enrolling in home visiting with a participating home visitor,
- not currently attending substance use treatment
Exclusion Criteria
Data sourced from ClinicalTrials.gov (NCT03750487). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.