MedDataX Logo

Trial Outcomes & Findings for Home Visitation Enhancing Linkages Project (NCT NCT03750487)

NCT ID: NCT03750487

Last Updated: 2024-05-07

Results Overview

e-SBI session 1 completion rate (% of participants who completed e-SBI session 1)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

Upon completion of e-SBI session 1, approximately 2-4 weeks after enrollment

Results posted on

2024-05-07

Participant Flow

Participant milestones

Participant milestones
Measure
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
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
Overall Study
STARTED
10
4
Overall Study
COMPLETED
10
4
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Home Visitation Enhancing Linkages Project

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
E-screening & Brief Intervention (e-SBI)
n=10 Participants
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
Control
n=4 Participants
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
Total
n=14 Participants
Total of all reporting groups
Age, Continuous
26.2 years
STANDARD_DEVIATION 4.5 • n=5 Participants
30.4 years
STANDARD_DEVIATION 3.4 • n=7 Participants
27.2 years
STANDARD_DEVIATION 4.5 • n=5 Participants
Sex: Female, Male
Female
10 Participants
n=5 Participants
4 Participants
n=7 Participants
14 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants
n=5 Participants
3 Participants
n=7 Participants
9 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
4 Participants
n=5 Participants
1 Participants
n=7 Participants
5 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
7 Participants
n=5 Participants
1 Participants
n=7 Participants
8 Participants
n=5 Participants
Region of Enrollment
United States
10 Participants
n=5 Participants
4 Participants
n=7 Participants
14 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure
E-screening & Brief Intervention (e-SBI)
n=10 Participants
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
Control
n=4 Participants
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
Feasibility: e-SBI Session 1 Completion Rate
Completed e-SBI session 1
8 Participants
4 Participants
Feasibility: e-SBI Session 1 Completion Rate
Did not complete e-SBI session 1
2 Participants
0 Participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure
E-screening & Brief Intervention (e-SBI)
n=4 Participants
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
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
Acceptability: Satisfaction With e-SBI Session 1 (Intervention Group Only)
4.03 units on a scale
Standard Deviation .45
—

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure
E-screening & Brief Intervention (e-SBI)
n=10 Participants
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
Control
n=4 Participants
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
Feasibility: e-SBI Session 2 Completion Rate
Completed e-SBI session 2
7 Participants
4 Participants
Feasibility: e-SBI Session 2 Completion Rate
Did not complete e-SBI session 2
3 Participants
0 Participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure
E-screening & Brief Intervention (e-SBI)
n=7 Participants
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
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
Acceptability: Satisfaction With e-SBI Session 2 (Intervention Group Only)
3.93 units on a scale
Standard Deviation .31
—

Adverse Events

E-screening & Brief Intervention (e-SBI)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sarah Dauber, Vice President

Partnership to End Addiction

Phone: 212-841-5270

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place