NCT03750487

Home Visitation Enhancing Linkages Project

Home Visitation Enhancing Linkages Project (HELP 2.0)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: The National Center on Addiction and Substance Abuse at Columbia University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Substance Use

Interventions

Type	Name	Description
BEHAVIORAL	e-screening & brief intervention (e-SBI)	Computer-delivered screening and brief motivational intervention targeting alcohol and drug use + goal-setting and content reinforcement
BEHAVIORAL	Control e-SBI	Computer-delivered screening and brief motivational intervention targeting healthy eating and exercise

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2018-11-23
• Last updated: 2024-05-07
• Results posted: 2024-05-07

Locations

1 site across 1 country: United States