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Home Visitation Enhancing Linkages Project (HELP)

Primary Purpose

Substance Use

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
e-screening & brief intervention (e-SBI)
Control e-SBI
Sponsored by
The National Center on Addiction and Substance Abuse at Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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:

Sites / Locations

  • Partnership to End Addiction - 485Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

e-screening & brief intervention (e-SBI)

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Timeline Follow Back Interview
Calendar-based method for assessing substance use. Outcome will include self-reported days of use.
Timeline Follow Back Interview
Calendar-based method for assessing substance use. Outcome will include self-reported days of use.
Timeline Follow Back Interview
Calendar-based method for assessing substance use. Outcome will include self-reported days of use.

Secondary Outcome Measures

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.
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.
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.
Treatment Services Review
Will use the Treatment Services Review to gather client report on attendance at any substance use treatment during the study period.

Full Information

First Posted
November 15, 2018
Last Updated
March 10, 2022
Sponsor
The National Center on Addiction and Substance Abuse at Columbia University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03750487
Brief Title
Home Visitation Enhancing Linkages Project
Acronym
HELP
Official Title
Home Visitation Enhancing Linkages Project (HELP 2.0)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The National Center on Addiction and Substance Abuse at Columbia University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
e-screening & brief intervention (e-SBI)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
e-screening & brief intervention (e-SBI)
Intervention Description
Computer-delivered screening and brief motivational intervention targeting alcohol and drug use + goal-setting and content reinforcement
Intervention Type
Behavioral
Intervention Name(s)
Control e-SBI
Intervention Description
Computer-delivered screening and brief motivational intervention targeting healthy eating and exercise
Primary Outcome Measure Information:
Title
Timeline Follow Back Interview
Description
Calendar-based method for assessing substance use. Outcome will include self-reported days of use.
Time Frame
baseline
Title
Timeline Follow Back Interview
Description
Calendar-based method for assessing substance use. Outcome will include self-reported days of use.
Time Frame
3 month follow-up
Title
Timeline Follow Back Interview
Description
Calendar-based method for assessing substance use. Outcome will include self-reported days of use.
Time Frame
6-month follow-up
Secondary Outcome Measure Information:
Title
Edinburgh Postnatal Depression Scale
Description
10-item scale measuring perinatal depressive symptoms. Total score range is 0-30, with depression possible with a score of 10 or higher.
Time Frame
baseline, 3- and 6-month follow-up
Title
Parenting Stress Index-Short Form
Description
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.
Time Frame
baseline, 3- and 6-month follow-up
Title
Retention in Home Visiting
Description
The number of home visits attended in the home visiting program will be mined from the home visiting program's management information system.
Time Frame
6 months
Title
Treatment Services Review
Description
Will use the Treatment Services Review to gather client report on attendance at any substance use treatment during the study period.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Dauber, PhD
Phone
2128415270
Email
sdauber@centeronaddiction.org
First Name & Middle Initial & Last Name or Official Title & Degree
Cori L Hammond, MPH
Phone
2128415304
Email
chammond@centeronaddiction.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Dauber, PhD
Organizational Affiliation
Partnership to End Addiction (formerly CASAColumbia)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Partnership to End Addiction - 485
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cori Hammond, MPH
Phone
704-662-2777
Email
chammond@toendaddiction.org
First Name & Middle Initial & Last Name & Degree
Sarah Dauber, PhD

12. IPD Sharing Statement

Learn more about this trial

Home Visitation Enhancing Linkages Project

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