Home Visitation Enhancing Linkages Project (HELP)

Home Visitation Enhancing Linkages Project (HELP 2.0)

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.

Study Overview

• Status: Completed
• Conditions: Substance Use
• Intervention / Treatment: Behavioral: e-screening & brief intervention (e-SBI); Behavioral: Control e-SBI

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10017
      • Partnership to End Addiction - 485

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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:

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: e-screening & brief intervention (e-SBI); Computer-delivered screening and brief motivational intervention targeting alcohol and drug use + goal-setting and content reinforcement
Sham Comparator: 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.	Behavioral: Control e-SBI; Computer-delivered screening and brief motivational intervention targeting healthy eating and exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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)
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edinburgh Postnatal Depression Scale	10-item scale measuring perinatal depressive symptoms. Total score range is 0-30, with depression possible with a score of 10 or higher.	baseline, 3- and 6-month follow-up
Parenting Stress Index-Short Form	36-item measure of stress associated with parenting. Subscales include parental distress, parent-child dysfunctional interaction, and difficult child, leading to a total stress indicator. Scores are calculated as percentiles: 15-80 are typical percentiles, with clinically significant levels starting at 85 for the parent-child dysfunctional interaction subscale and 90 for all other subscales. Defensive responding is defined as a raw score below ten.	baseline, 3- and 6-month follow-up
Retention in Home Visiting	The number of home visits attended in the home visiting program will be mined from the home visiting program's management information system.	6 months
Treatment Services Review	Will use the Treatment Services Review to gather client report on attendance at any substance use treatment during the study period.	6 months

Collaborators and Investigators

• Sponsor: The National Center on Addiction and Substance Abuse at Columbia University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Sarah Dauber, PhD, Partnership to End Addiction (formerly CASAColumbia)

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: November 20, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: HELP 2.0; R34DA045831 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No