Substance UseHELPNCT03750487

Home Visitation Enhancing Linkages Project

A study testing e-screening & brief intervention (e-SBI) in people with Substance Use, run by The National Center on Addiction and Substance Abuse at Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Substance Use
What is being tested?: e-screening & brief intervention (e-SBI)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2020to 31 Oct 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Partnership to End Addiction - 485
New York, New York, 10017

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested: e-screening & brief intervention (e-SBI), Control e-SBI
Medical subject headings: Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

e-screening & brief intervention (e-SBI)Behavioural
Computer-delivered screening and brief motivational intervention targeting alcohol and drug use + goal-setting and content reinforcement
Control e-SBIBehavioural
Computer-delivered screening and brief motivational intervention targeting healthy eating and exercise

Study groups in NCT03750487
Study group	Role	What they receive
e-screening & brief intervention (e-SBI)	Experimental	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. Receives: Behavioral: e-screening & brief intervention (e-SBI)
Control	Sham comparator	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. Receives: Behavioral: Control e-SBI

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility: e-SBI Session 1 Completion Rate
e-SBI session 1 completion rate (% of participants who completed e-SBI session 1)
Measured: 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:
1. How much did you like this session?
2. How easy was it to use this program?
3. How interesting was this session?
4. How respectful was this session?
5. How much were you bothered by parts of this session? (reverse scored)
6. How much did this session get you thinking about your substance use?
7. How much did you feel you were helped during this session?
8. 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.
Measured: 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)
Measured: 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:
1. How much did you like this session?
2. How easy was it to use this program?
3. How interesting was this session?
4. How respectful was this session?
5. How much were you bothered by parts of this session? (reverse scored)
6. How much did this session get you thinking about your substance use?
7. How much did you feel you were helped during this session?
8. 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.
Measured: Upon completion of e-SBI session 2, approximately 4-6 weeks after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 202031 Oct 2022

First posted23 Nov 2018
Study start1 Dec 2020
Primary completion31 Oct 2022
Study completion31 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Substance UseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03750487
Sponsor's protocol ID: HELP 2.0
Other IDs: R34DA045831
Acronym: HELP
Status last verified: Apr 2024
First submitted: 15 Nov 2018
Last updated: 7 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Substance Use trials

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Home Visitation Enhancing Linkages Project (HELP 2.0)
ClinicalTrials.gov ID: NCT03750487
Acronym / sponsor ID: HELP / HELP 2.0
Conditions: Substance Use
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: The National Center on Addiction and Substance Abuse at Columbia UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 1 Dec 2020 (actual)
Primary completion: 31 Oct 2022 (actual)
Study completion: 31 Oct 2022 (actual)
First posted: 23 Nov 2018 (actual)
Results: Posted 7 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
e-screening & brief intervention (e-SBI)	Experimental	Behavioral: 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.
Control	Sham comparator	Behavioral: Control e-SBIThe 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
e-screening & brief intervention (e-SBI)Computer-delivered screening and brief motivational intervention targeting alcohol and drug use + goal-setting and content reinforcement	Behavioural	e-screening & brief intervention (e-SBI)
Control e-SBIComputer-delivered screening and brief motivational intervention targeting healthy eating and exercise	Behavioural	Control

Primary outcome

Feasibility: e-SBI Session 1 Completion Rate
Time frame: Upon completion of e-SBI session 1, approximately 2-4 weeks after enrollment
e-SBI session 1 completion rate (% of participants who completed e-SBI session 1)
Acceptability: Satisfaction With e-SBI Session 1 (Intervention Group Only)
Time frame: Upon completion of e-SBI session 1, approximately 2-4 weeks after enrollment
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: 1. How much did you like this session? 2. How easy was it to use this program? 3. How interesting was this session? 4. How respectful was this session? 5. How much were you bothered by parts of this session? (reverse scored) 6. How much did this session get you thinking about your substance use? 7. How much did you feel you were helped during this session? 8. 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.
Feasibility: e-SBI Session 2 Completion Rate
Time frame: Upon completion of e-SBI session 2 (approximately 4-6 weeks after enrollment)
e-SBI session 2 completion rate (% of participants who completed e-SBI session 2)
Acceptability: Satisfaction With e-SBI Session 2 (Intervention Group Only)
Time frame: Upon completion of e-SBI session 2, approximately 4-6 weeks after enrollment
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: 1. How much did you like this session? 2. How easy was it to use this program? 3. How interesting was this session? 4. How respectful was this session? 5. How much were you bothered by parts of this session? (reverse scored) 6. How much did this session get you thinking about your substance use? 7. How much did you feel you were helped during this session? 8. 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.

Results and safety

Results posted to the registry on 7 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
E-screening & Brief Intervention (e-SBI)	10	10
Control	4	4

Primary outcome: Feasibility: e-SBI Session 1 Completion Rate

Time frame: Upon completion of e-SBI session 1, approximately 2-4 weeks after enrollment. Count of participants. Unit: Participants

Measure	E-screening & Brief Intervention (e-SBI) n = 10	Control n = 4
Completed e-SBI session 1	8	4
Did not complete e-SBI session 1	2	0

Primary outcome: Acceptability: Satisfaction With e-SBI Session 1 (Intervention Group Only)

Time frame: Upon completion of e-SBI session 1, approximately 2-4 weeks after enrollment. Mean (Standard Deviation). Unit: units on a scale

Measure	E-screening & Brief Intervention (e-SBI) n = 4
Value	4.03 (.45)

Population analysed: Only 4 people completed the acceptability scale following e-SBI session 1

Primary outcome: Feasibility: e-SBI Session 2 Completion Rate

Time frame: Upon completion of e-SBI session 2 (approximately 4-6 weeks after enrollment). Count of participants. Unit: Participants

Measure	E-screening & Brief Intervention (e-SBI) n = 10	Control n = 4
Completed e-SBI session 2	7	4
Did not complete e-SBI session 2	3	0

Primary outcome: Acceptability: Satisfaction With e-SBI Session 2 (Intervention Group Only)

Time frame: Upon completion of e-SBI session 2, approximately 4-6 weeks after enrollment. Mean (Standard Deviation). Unit: units on a scale

Measure	E-screening & Brief Intervention (e-SBI) n = 7
Value	3.93 (.31)

Population analysed: 7 people completed the acceptability scale following e-SBI session 2

Adverse events

Time frame: Approximately 6 weeks (time from enrollment until completion of e-SBI sessions).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
E-screening & Brief Intervention (e-SBI)	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Control	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Limitations and caveats (from the sponsor): There were many delays and challenges associated with the COVID-19 pandemic. Due to disruptions in the home visiting service system caused by the pandemic, recruitment for the study was extremely slow. After enrolling the first 4 participants, we made the decision along with the DSMB, the IRB, and the funder to change the design from an RCT to a single-condition pre-post feasibility study, with all participants assigned to the intervention condition.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Substance Use

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sarah Dauber, PhD principal investigator

Partnership to End Addiction (formerly CASAColumbia)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing e-screening & brief intervention (e-SBI) in people with Substance Use, run by The National Center on Addiction and Substance Abuse at Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility: e-SBI Session 1 Completion Rate (time frame: Upon completion of e-SBI session 1, approximately 2-4 weeks after enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03750487.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.