Home Visitation Enhancing Linkages Project

NCT ID: NCT03750487

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-10-31

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.

Conditions

Substance Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

e-screening & brief intervention (e-SBI)

A two-session (20 minutes each) computer-delivered screening and brief motivational intervention targeting alcohol and drug use. Computerized screening is conducted using the ASSIST. Session 1 of the BI includes personalized feedback, readiness to change interventions, and goal setting around substance use. Session 2 will contain motivational content reinforcing engagement in home visiting and information around other challenges mothers may experience including tobacco use, postpartum depression, and intimate partner violence.

Group Type: EXPERIMENTAL

e-screening & brief intervention (e-SBI)

Intervention Type: BEHAVIORAL

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

Control

The control group will receive a similar 2-session brief motivational intervention. Session 1 focuses on nutrition and healthy eating, session 2 focuses on exercising while pregnant or in the postpartum period.

Group Type: SHAM_COMPARATOR

Control e-SBI

Intervention Type: BEHAVIORAL

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

Interventions

e-screening & brief intervention (e-SBI)

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

Intervention Type: BEHAVIORAL

Control e-SBI

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

The National Center on Addiction and Substance Abuse at Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Dauber, PhD

Role: PRINCIPAL_INVESTIGATOR

Partnership to End Addiction (formerly CASAColumbia)

Locations

Partnership to End Addiction - 485

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R34DA045831

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HELP 2.0

Identifier Type: -

Identifier Source: org_study_id