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| Name | Class |
|---|---|
| AltaMed Health Services Corporation | OTHER |
| University of Pittsburgh Medical Center | OTHER |
| Patient-Centered Outcomes Research Institute | OTHER |
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Brief motivational interviewing intervention to address alcohol use among diverse teens 12-17.
The six-item CRAFFT will be used to screen teens at our partner clinics for risky AC use. For those that screen in as at-risk and express interest in the study, the teen's case manager will complete an online consent/assent form with the parent and teen that contains contact information for the teen so that investigators can follow up with the teen for surveys and intervention delivery or for providing an informational brochure. When the online consent/assent form is completed, the teen will be sent a personalized link to complete their baseline survey. Upon survey completion, the teen will receive a link that has their electronic gift card payment, and the case manager will be notified that a particular ID has completed the survey. The case manager will be informed by study staff whether to schedule that ID for enhanced usual care (EUC) or the Chat intervention. Investigators expect each teen to be scheduled within 30 days of completing their baseline survey to receive EUC or Chat. The informational brochure for the EUC will be handed to the teen during the visit or securely emailed, and Chat could take place either via a virtual or in-person visit. Whether or not the teen completes EUC or Chat, every teen will be followed by the RAND Survey Research Group to complete their follow-up web-based surveys based on timing of completion of their baseline survey. Teens will receive gift card incentives for completing the 3-month, 6-month, and 12-month surveys. Investigators will begin recruitment in month 9 of the project. Briefly, investigators expect to recruit from study month 9 to month 42 for the baseline survey. Investigators expect the Chat intervention to occur from months 9 to 42 the 3-month follow-up from months 12 to 45, 6-month from months 15 to 48, and the 12-month from months 21 to 53. Out of an anticipated 5,644 clients that our partner clinics will screen, investigators expect approximately 847 (15%) to screen in as at-risk on the CRAFFT and anticipate that approximately 500 (~60%) will consent into the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Usual Care | Active Comparator | When the online consent/assent form is completed, the teen will be sent a personalized link to complete their baseline survey. Upon survey completion, the teen will receive a link that has their electronic gift card payment, and the case manager will be notified that a particular ID has completed the survey. The case manager will be informed by study staff whether to schedule that ID for enhanced usual care (EUC) or the Chat intervention. If they are randomized as EUC, the informational brochure for the EUC will be handed to the teen during the visit or securely emailed to them. Whether the teen completes EUC or Chat, every teen will be followed by the RAND Survey Research Group to complete their paid follow-up web-based surveys based on timing of completion of their baseline survey. |
|
| Chat Intervention | Experimental | When the online consent/assent form is completed, the teen will be sent a personalized link to complete their baseline survey. Upon survey completion, the teen will receive a link that has their electronic gift card payment, and the case manager will be notified that a particular ID has completed the survey. The case manager will be informed by study staff whether to schedule that ID for enhanced usual care (EUC) or the Chat Intervention. If they are randomized as Chat Intervention, Chat will take place either via a virtual or in-person visit. Whether the teen completes EUC or Chat, every teen will be followed by the RAND Survey Research Group to complete their paid follow-up web-based surveys based on timing of completion of their baseline survey. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chat | Behavioral | Chat is a brief motivational interviewing intervention for partner clinic participants with an alcohol or cannabis use condition. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol - change in frequency of use | We will assess both the number of times participants have used alcohol in the past three months (from none to 31 or more times) and the number of days in the past month participants report use of alcohol. | Baseline to 3 months |
| Alcohol - change in frequency of use | We will assess both the number of times participants have used alcohol in the past three months (from none to 31 or more times) and the number of days in the past month participants report use of alcohol. | 3 months to 6 months |
| Alcohol - change in frequency of use | We will assess both the number of times participants have used alcohol in the past six months (from none to 31 or more times) and the number of days in the past month participants report use of alcohol. | 6 months to 12 months |
| Cannabis - change in frequency of use | We will assess both the number of times participants have used cannabis in the past three months (from none to 31 or more times) and the number of days in the past month participants report use of cannabis. | Baseline to 3 months |
| Cannabis - change in frequency of use | We will assess both the number of times participants have used cannabis in the past three months (from none to 31 or more times) and the number of days in the past month participants report use of cannabis. | 3 months to 6 months |
| Cannabis - change in frequency of use | We will assess both the number of times participants have used cannabis in the past six months (from none to 31 or more times) and the number of days in the past month participants report use of cannabis. |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol - change in time spent around peers | Participants will be asked how often they are with people their age who are using alcohol (1=never to 4=often). | Baseline to 3 months |
| Alcohol - change in time spent around peers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth J D'Amico, PhD | Contact | 3103930411 | 6487 | damico@rand.org |
| Michael J Woodward | Contact | 3103930411 | 6595 | michaelw@rand.org |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth J. D'Amico, PhD | RAND | Principal Investigator |
| Alina I Palimaru, PhD | RAND | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AltaMed Health Services | Recruiting | Commerce | California | 90022 | United States |
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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 | Feb 4, 2025 | Feb 4, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000066608 | Underage Drinking |
| ID | Term |
|---|---|
| D000294 | Adolescent Behavior |
| D001519 | Behavior |
| D000428 | Alcohol Drinking |
| D004327 | Drinking Behavior |
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| ID | Term |
|---|---|
| D002795 | Choline O-Acetyltransferase |
| ID | Term |
|---|---|
| D000123 | Acetyltransferases |
| D000217 | Acyltransferases |
| D014166 | Transferases |
| D004798 | Enzymes |
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Enhanced Usual Care vs Chat Intervention
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| Enhanced Usual Care | Behavioral | An informational brochure will be give to partner clinic participants with an alcohol or cannabis use condition. |
|
| 6 months to 12 months |
| Alcohol - change in consequences of use | Alcohol consequences (e.g., blacking out, regretted sexual situation) will be assessed with the Brief Young Adult Alcohol Consequences Questionnaire (0 to 20 or more times, with higher scores indicating a worse outcome). | Baseline to 3 months |
| Alcohol - change in consequences of use | Alcohol consequences (e.g., blacking out, regretted sexual situation) will be assessed with the Brief Young Adult Alcohol Consequences Questionnaire (0 to 20 or more times, with higher scores indicating a worse outcome). | 3 months to 6 months |
| Alcohol - change in consequences of use | Alcohol consequences (e.g., blacking out, regretted sexual situation) will be assessed with the Brief Young Adult Alcohol Consequences Questionnaire (0 to 20 or more times, with higher scores indicating a worse outcome). | 6 months to 12 months |
| Cannabis - change in consequences of use | Cannabis consequences (e.g., poor memory, too much time using) will be assessed with the Brief Marijuana Consequences Questionnaire (0 to 20 or more times, with higher scores indicating a worse outcome). | Baseline to 3 months |
| Cannabis - change in consequences of use | Cannabis consequences (e.g., poor memory, too much time using) will be assessed with the Brief Marijuana Consequences Questionnaire (0 to 20 or more times, with higher scores indicating a worse outcome). | 3 months to 6 months |
| Cannabis - change in consequences of use | Cannabis consequences (e.g., poor memory, too much time using) will be assessed with the Brief Marijuana Consequences Questionnaire (0 to 20 or more times, with higher scores indicating a worse outcome). | 6 months to 12 months |
Participants will be asked how often they are with people their age who are using alcohol (1=never to 4=often).
| 3 months to 6 months |
| Alcohol - change in time spent around peers | Participants will be asked how often they are with people their age who are using alcohol (1=never to 4=often). | 6 months to 12 months |
| Cannabis - change in time spent around peers | Participants will be asked how often they are with people their age who are using cannabis (1=never to 4=often). | Baseline to 3 months |
| Cannabis - change in time spent around peers | Participants will be asked how often they are with people their age who are using cannabis (1=never to 4=often). | 3 months to 6 months |
| Cannabis - change in time spent around peers | Participants will be asked how often they are with people their age who are using cannabis (1=never to 4=often). | 6 months to 12 months |
| Alcohol - change in motivation to change use | We will measure motivation to change use by asking participants where they may be in their thinking about reducing or quitting their alcohol use using a scale of 1-10 where 1 = "I have quit using alcohol and will never go back" and 10 = "I enjoy using alcohol and have decided never to change it." | Baseline to 3 months |
| Alcohol - change in motivation to change use | We will measure motivation to change use by asking participants where they may be in their thinking about reducing or quitting their alcohol use using a scale of 1-10 where 1 = "I have quit using alcohol and will never go back" and 10 = "I enjoy using alcohol and have decided never to change it." | 3 months to 6 months |
| Alcohol - change in motivation to change use | We will measure motivation to change use by asking participants where they may be in their thinking about reducing or quitting their alcohol use using a scale of 1-10 where 1 = "I have quit using alcohol and will never go back" and 10 = "I enjoy using alcohol and have decided never to change it." | 6 months to 12 months |
| Cannabis - change in motivation to change use | We will measure motivation to change use by asking participants where they may be in their thinking about reducing or quitting their cannabis use using a scale of 1-10 where 1 = "I have quit using cannabis and will never go back" and 10 = "I enjoy using cannabis and have decided never to change it." | Baseline to 3 months |
| Cannabis - change in motivation to change use | We will measure motivation to change use by asking participants where they may be in their thinking about reducing or quitting their cannabis use using a scale of 1-10 where 1 = "I have quit using cannabis and will never go back" and 10 = "I enjoy using cannabis and have decided never to change it." | 3 months to 6 months |
| Cannabis - change in motivation to change use | We will measure motivation to change use by asking participants where they may be in their thinking about reducing or quitting their cannabis use using a scale of 1-10 where 1 = "I have quit using cannabis and will never go back" and 10 = "I enjoy using cannabis and have decided never to change it." | 6 months to 12 months |
| Change in use of behavioral health care services | We will measure use of behavioral health care services (separate items for mental health and substance use), including whether there are unmet needs for behavioral health services (i.e., perceived a need to get treatment but didn't get it) and perceived reasons for those unmet needs (e.g., stigma, transportation, cost). | Baseline to 3 months |
| Change in use of behavioral health care services | We will measure use of behavioral health care services (separate items for mental health and substance use), including whether there are unmet needs for behavioral health services (i.e., perceived a need to get treatment but didn't get it) and perceived reasons for those unmet needs (e.g., stigma, transportation, cost). | 3 months to 6 months |
| Change in use of behavioral health care services | We will measure use of behavioral health care services (separate items for mental health and substance use), including whether there are unmet needs for behavioral health services (i.e., perceived a need to get treatment but didn't get it) and perceived reasons for those unmet needs (e.g., stigma, transportation, cost). | 6 months to 12 months |
| University of Pittsburgh Medical Center Children's Hospital | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
|
| D045762 |
| Enzymes and Coenzymes |