Home Visitation Enhancing Linkages Project

NCT03750487 | Completed Results DMC

• 2 other identifiers: HELP 2.0R34DA045831
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use

Outcome Measures

Primary Outcomes (4)

• 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: 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.

  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: 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.

  Upon completion of e-SBI session 2, approximately 4-6 weeks after enrollment

Study Arms (2)

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.

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.

Behavioral: Control e-SBI

Interventions

e-screening & brief intervention (e-SBI) BEHAVIORAL

Computer-delivered screening and brief motivational intervention targeting alcohol and drug use + goal-setting and content reinforcement

e-screening & brief intervention (e-SBI)

Control e-SBI BEHAVIORAL

Computer-delivered screening and brief motivational intervention targeting healthy eating and exercise

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking,
• 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

Sponsors & Collaborators

• The National Center on Addiction and Substance Abuse at Columbia University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Partnership to End Addiction - 485

New York, New York, 10017, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

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.

Results Point of Contact

• Title: Sarah Dauber, Vice President
• Organization: Partnership to End Addiction

sdauber@toendaddiction.org

212-841-5270

Study Officials

• Sarah Dauber, PhD

  Partnership to End Addiction (formerly CASAColumbia)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 23, 2018
• Study Start: December 1, 2020
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: May 7, 2024
• Results First Posted: May 7, 2024

Record last verified: 2024-04

Locations

US (1)