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| ID | Type | Description | Link |
|---|---|---|---|
| R34DA045831 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| e-screening & brief intervention (e-SBI) | Behavioral | Computer-delivered screening and brief motivational intervention targeting alcohol and drug use + goal-setting and content reinforcement |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Dauber, PhD | Partnership to End Addiction (formerly CASAColumbia) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Partnership to End Addiction - 485 | New York | New York | 10017 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility: e-SBI Session 1 Completion Rate | e-SBI session 1 completion rate (% of participants who completed e-SBI session 1) | Posted | Count of Participants | Participants | Upon completion of e-SBI session 1, approximately 2-4 weeks after enrollment |
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Approximately 6 weeks (time from enrollment until completion of e-SBI sessions).
Adverse events: any untoward medical occurrence that occurs during administration of an intervention, which may or may not have a causal relation with the intervention.
Serious adverse events: any medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; creates persistent or significant disability/incapacity, or a congenital anomaly/birth defects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Dauber, Vice President | Partnership to End Addiction | 212-841-5270 | sdauber@toendaddiction.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2020 | Mar 15, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
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| D003419 | Crisis Intervention |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Control e-SBI | Behavioral | Computer-delivered screening and brief motivational intervention targeting healthy eating and exercise |
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| Upon completion of e-SBI session 2, approximately 4-6 weeks after enrollment |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | 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 |
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| 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:
| Only 4 people completed the acceptability scale following e-SBI session 1 | Posted | Mean | Standard Deviation | units on a scale | Upon completion of e-SBI session 1, approximately 2-4 weeks after enrollment |
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| Primary | Feasibility: e-SBI Session 2 Completion Rate | e-SBI session 2 completion rate (% of participants who completed e-SBI session 2) | Posted | Count of Participants | Participants | Upon completion of e-SBI session 2 (approximately 4-6 weeks after enrollment) |
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| 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:
| 7 people completed the acceptability scale following e-SBI session 2 | Posted | Mean | Standard Deviation | units on a scale | Upon completion of e-SBI session 2, approximately 4-6 weeks after enrollment |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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 | 0 | 4 | 0 | 4 | 0 | 4 |
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