Home Visitation Enhancing Linkages Project (HELP 2.0)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Feasibility: e-SBI Session 2 Completion Rate
Study Overview
Brief 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.
Detailed Description
The purpose of this clinical trial is to pilot test an electronic screening and brief intervention (e-SBI) that will be adapted for use with pregnant and postpartum women in home visiting (HV) programs. The e-SBI will be tested in a small randomized trial in two home visiting sites, with 20 home visitors and 40 clients. Home visitors will be randomized to the control intervention or the e-SBI. Clients will be surveyed at baseline, and 3- and 6- month follow-up to track e-SBI impacts 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. Total enrollment was N = 14. Four participants were assigned to the control condition prior to elimination of randomization. The remaining 10 participants were assigned to the intervention condition. Primary study outcomes were feasibility and acceptability.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
- Not provided
Outcomes
Primary Outcomes
Feasibility: e-SBI Session 2 Completion Rate
Time Frame: Upon completion of e-SBI session 2 (approximately 4-6 weeks after enrollment)
e-SBI session 2 completion rate (% of participants who completed e-SBI session 2)
Feasibility: e-SBI Session 1 Completion Rate
Time Frame: Upon completion of e-SBI session 1, approximately 2-4 weeks after enrollment
e-SBI session 1 completion rate (% of participants who completed e-SBI session 1)
Acceptability: Satisfaction With e-SBI Session 2 (Intervention Group Only)
Time Frame: Upon completion of e-SBI session 2, approximately 4-6 weeks after enrollment
8-item user satisfaction survey based on the Technology Acceptance Model completed after each e-SBI session. The scale was developed by Ondersma in prior studies of the e-SBI, it does not have a formal title. The scale measures satisfaction with the e-SBI session. The following items are included in the scale: 1. How much did you like this session? 2. How easy was it to use this program? 3. How interesting was this session? 4. How respectful was this session? 5. How much were you bothered by parts of this session? (reverse scored) 6. How much did this session get you thinking about your substance use? 7. How much did you feel you were helped during this session? 8. How interested are you in working with the program again? Items were rated on a 1 to 5 Likert scale. Average across all 7 items was calculated, with item 5 reverse scored. Possible range of scores is 1 to 5. Higher scores indicate higher satisfaction with the e-SBI session.
Acceptability: Satisfaction With e-SBI Session 1 (Intervention Group Only)
Time Frame: Upon completion of e-SBI session 1, approximately 2-4 weeks after enrollment
8-item user satisfaction survey based on the Technology Acceptance Model completed after each e-SBI session. The scale was developed by Ondersma in prior studies of the e-SBI, it does not have a formal title. The scale measures satisfaction with the e-SBI session. The following items are included in the scale: 1. How much did you like this session? 2. How easy was it to use this program? 3. How interesting was this session? 4. How respectful was this session? 5. How much were you bothered by parts of this session? (reverse scored) 6. How much did this session get you thinking about your substance use? 7. How much did you feel you were helped during this session? 8. How interested are you in working with the program again? Items were rated on a 1 to 5 Likert scale. Average across all 7 items was calculated, with item 5 reverse scored. Possible range of scores is 1 to 5. Higher scores indicate higher satisfaction with the e-SBI session.
Secondary Outcomes
No secondary outcomes reported