Home Visitation Enhancing Linkages Project

Study Overview
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Brief Summary
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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
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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 10 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.

Official Title
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Home Visitation Enhancing Linkages Project (HELP 2.0)

Conditions
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Substance Use

Intervention / Treatment
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* Behavioral: e-screening & brief intervention (e-SBI)
* Behavioral: Control e-SBI


Participation Criteria
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Eligibility Criteria
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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:

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timeline Follow Back Interview | Calendar-based method for assessing substance use. Outcome will include self-reported days of use. | baseline | 
| Timeline Follow Back Interview | Calendar-based method for assessing substance use. Outcome will include self-reported days of use. | 3 month follow-up | 
| Timeline Follow Back Interview | Calendar-based method for assessing substance use. Outcome will include self-reported days of use. | 6-month follow-up | 

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 |