Substance Use
Conditions
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.
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.
Interventions
BEHAVIORALe-screening & brief intervention (e-SBI)
Computer-delivered screening and brief motivational intervention targeting alcohol and drug use + goal-setting and content reinforcement
BEHAVIORALControl e-SBI
Computer-delivered screening and brief motivational intervention targeting healthy eating and exercise
Sponsors
National Institute on Drug Abuse (NIDA)
The National Center on Addiction and Substance Abuse at Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: e-SBI Session 1 Completion Rate | 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) | 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 | 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) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
e-screening & brief intervention (e-SBI): Computer-delivered screening and brief motivational intervention targeting alcohol and drug use + goal-setting and content reinforcement | 10 |
| 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.
Control e-SBI: Computer-delivered screening and brief motivational intervention targeting healthy eating and exercise | 4 |
| Total | 14 |
Baseline characteristics
| Characteristic | E-screening & Brief Intervention (e-SBI) | Total | Control |
|---|---|---|---|
| Age, Continuous | 26.2 years STANDARD_DEVIATION 4.5 | 27.2 years STANDARD_DEVIATION 4.5 | 30.4 years STANDARD_DEVIATION 3.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 9 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 5 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 8 Participants | 1 Participants |
| Race (NIH/OMB) White | 0 Participants | 2 Participants | 2 Participants |
| Region of Enrollment United States | 10 Participants | 14 Participants | 4 Participants |
| Sex: Female, Male Female | 10 Participants | 14 Participants | 4 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 4 |
| other Total, other adverse events | 0 / 10 | 0 / 4 |
| serious Total, serious adverse events | 0 / 10 | 0 / 4 |
Outcome results
Primary
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.
Time frame: Upon completion of e-SBI session 1, approximately 2-4 weeks after enrollment
Population: Only 4 people completed the acceptability scale following e-SBI session 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E-screening & Brief Intervention (e-SBI) | Acceptability: Satisfaction With e-SBI Session 1 (Intervention Group Only) | 4.03 units on a scale | Standard Deviation 0.45 |
Primary
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.
Time frame: Upon completion of e-SBI session 2, approximately 4-6 weeks after enrollment
Population: 7 people completed the acceptability scale following e-SBI session 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E-screening & Brief Intervention (e-SBI) | Acceptability: Satisfaction With e-SBI Session 2 (Intervention Group Only) | 3.93 units on a scale | Standard Deviation 0.31 |
Primary
Feasibility: e-SBI Session 1 Completion Rate
e-SBI session 1 completion rate (% of participants who completed e-SBI session 1)
Time frame: Upon completion of e-SBI session 1, approximately 2-4 weeks after enrollment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| E-screening & Brief Intervention (e-SBI) | Feasibility: e-SBI Session 1 Completion Rate | Completed e-SBI session 1 | 8 Participants |
| E-screening & Brief Intervention (e-SBI) | Feasibility: e-SBI Session 1 Completion Rate | Did not complete e-SBI session 1 | 2 Participants |
| Control | Feasibility: e-SBI Session 1 Completion Rate | Completed e-SBI session 1 | 4 Participants |
| Control | Feasibility: e-SBI Session 1 Completion Rate | Did not complete e-SBI session 1 | 0 Participants |
Primary
Feasibility: e-SBI Session 2 Completion Rate
e-SBI session 2 completion rate (% of participants who completed e-SBI session 2)
Time frame: Upon completion of e-SBI session 2 (approximately 4-6 weeks after enrollment)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| E-screening & Brief Intervention (e-SBI) | Feasibility: e-SBI Session 2 Completion Rate | Completed e-SBI session 2 | 7 Participants |
| E-screening & Brief Intervention (e-SBI) | Feasibility: e-SBI Session 2 Completion Rate | Did not complete e-SBI session 2 | 3 Participants |
| Control | Feasibility: e-SBI Session 2 Completion Rate | Completed e-SBI session 2 | 4 Participants |
| Control | Feasibility: e-SBI Session 2 Completion Rate | Did not complete e-SBI session 2 | 0 Participants |