Home Visitation Enhancing Linkages Project

Not Applicable

Completed

• Conditions: Substance Use

• Registration Number: NCT03750487
• Lead Sponsor: The National Center on Addiction and Substance Abuse at Columbia University

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 Timeline

• Study First Submitted: 2018-11-15
• Study First Submitted QC: 2018-11-20
• Study First Posted: 2018-11-23
• Study Start: 2020-12-01
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Results First Submitted: 2024-03-15
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-11
• Last Update Submitted: 2024-04-11
• Results First Posted: 2024-05-07
• Last Update Posted: 2024-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility: e-SBI Session 1 Completion Rate	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)
Feasibility: e-SBI Session 2 Completion Rate	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)
Acceptability: Satisfaction With e-SBI Session 2 (Intervention Group Only)	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)	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.

Trial Locations

Locations (1)

Partnership to End Addiction - 485; 🇺🇸 New York, New York, United States