Clinical trial NCT03750487: Home Visitation Enhancing Linkages Project
Official title: Home Visitation Enhancing Linkages Project (HELP 2.0)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Lead sponsor: The National Center on Addiction and Substance Abuse at Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-11-23
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Exclusion Criteria:

Primary outcomes:
measure: Feasibility: e-SBI Session 1 Completion Rate
timeFrame: Upon completion of e-SBI session 1, approximately 2-4 weeks after enrollment
measure: Acceptability: Satisfaction With e-SBI Session 1 (Intervention Group Only)
timeFrame: Upon completion of e-SBI session 1, approximately 2-4 weeks after enrollment
measure: Feasibility: e-SBI Session 2 Completion Rate
timeFrame: Upon completion of e-SBI session 2 (approximately 4-6 weeks after enrollment)
measure: Acceptability: Satisfaction With e-SBI Session 2 (Intervention Group Only)
timeFrame: Upon completion of e-SBI session 2, approximately 4-6 weeks after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Partnership to End Addiction - 485
state: New York
Study officials:
affiliation: Partnership to End Addiction (formerly CASAColumbia)
name: Sarah Dauber, PhD
role: PRINCIPAL_INVESTIGATOR
References: