Skip to main content
OpenTrials
Completed

NCT Number: NCT03750487

Home Visitation Enhancing Linkages Project

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Substance Use Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Partnership to End Addiction - 485

New York, 10017, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

e-screening & brief intervention (e-SBI)

Behavioral

Computer-delivered screening and brief motivational intervention targeting alcohol and drug use + goal-setting and content reinforcement

Control e-SBI

Behavioral

Computer-delivered screening and brief motivational intervention targeting healthy eating and exercise

Primary outcomes

  1. 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)

  2. 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:

    • 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.

  3. 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)

  4. 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:

    • 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.

Sponsors and collaborators

Lead sponsor

The National Center on Addiction and Substance Abuse at Columbia University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Home Visitation Enhancing Linkages Project (HELP 2.0)

Acronym: HELP

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 23, 2018
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.