Home Visitation Enhancing Linkages Project

Substance Use Clinical Trial

— HELP  

Official title:

Home Visitation Enhancing Linkages Project (HELP 2.0)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03750487
• Other study ID #: HELP 2.0
• Secondary ID: R34DA045831
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: October 31, 2022

Study information

• Verified date: April 2024
• Source: The National Center on Addiction and Substance Abuse at Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Substance Use
• Substance-Related Disorders

Intervention

Behavioral:
• e-screening & brief intervention (e-SBI)
Computer-delivered screening and brief motivational intervention targeting alcohol and drug use + goal-setting and content reinforcement
• Control e-SBI
Computer-delivered screening and brief motivational intervention targeting healthy eating and exercise

Locations

Country	Name	City	State
United States	Partnership to End Addiction - 485	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
The National Center on Addiction and Substance Abuse at Columbia University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: e-SBI Session 1 Completion Rate	e-SBI session 1 completion rate (% of participants who completed e-SBI session 1)	Upon completion of e-SBI session 1, approximately 2-4 weeks after enrollment
Primary	Acceptability: Satisfaction With e-SBI Session 1 (Intervention Group Only)	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: How much did you like this session?; How easy was it to use this program?; How interesting was this session?; How respectful was this session?; How much were you bothered by parts of this session? (reverse scored); How much did this session get you thinking about your substance use?; How much did you feel you were helped during this session?; 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.	Upon completion of e-SBI session 1, approximately 2-4 weeks after enrollment
Primary	Feasibility: e-SBI Session 2 Completion Rate	e-SBI session 2 completion rate (% of participants who completed e-SBI session 2)	Upon completion of e-SBI session 2 (approximately 4-6 weeks after enrollment)
Primary	Acceptability: Satisfaction With e-SBI Session 2 (Intervention Group Only)	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: How much did you like this session?; How easy was it to use this program?; How interesting was this session?; How respectful was this session?; How much were you bothered by parts of this session? (reverse scored); How much did this session get you thinking about your substance use?; How much did you feel you were helped during this session?; 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.	Upon completion of e-SBI session 2, approximately 4-6 weeks after enrollment