Brief Intervention for Underage Drinking

Recruiting at 1 trial location

Overseen By Michael J Woodward

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: RAND

Disqualifiers: Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a brief motivational chat can help teens aged 12 to 17 address risky alcohol use. Participants will either engage in a personalized conversation (the Chat Intervention, also known as Motivational Interviewing for Adolescents At-Risk for Substance Use) or receive enhanced usual care with informational materials. The researchers aim to determine which method more effectively reduces alcohol use among teens. Teens who receive healthcare at one of the participating systems and are considered at risk for alcohol or cannabis use might be suitable for this trial. As an unphased trial, this study offers teens the chance to contribute to important research that could shape future interventions for risky alcohol use.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this intervention is safe for teens?

Previous studies on programs like the CHAT intervention, which use motivational interviewing, have shown promising safety results. Research indicates that these programs for teens at risk of substance use are generally well-received. In one study, 91% of teens expressed satisfaction with their CHAT session, and 92% rated the discussion as good or excellent, indicating that teens found the process comfortable and engaging.

Motivational interviewing has also been used in various settings with teens to encourage positive changes. Although specific negative effects were not reported in the available data, the high satisfaction rates suggest that the program does not cause significant discomfort or harm.

In summary, the CHAT intervention appears safe for teens, with positive feedback from participants in previous research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Chat Intervention" for addressing underage drinking because it offers a personalized and flexible approach compared to traditional methods. Unlike standard treatments that often involve in-person counseling or educational materials, this intervention utilizes virtual or in-person chat sessions tailored to the individual's needs, making it more accessible and engaging for teens. Additionally, the use of technology for personalized interaction can increase the likelihood of meaningful engagement and behavior change, providing a novel method that aligns with how teens communicate today. This innovative approach aims to make interventions more relatable and effective, which could lead to better outcomes in reducing underage drinking.

What evidence suggests that the Chat intervention is effective for reducing underage drinking?

Research has shown that motivational interviewing, such as the Chat Intervention, can help reduce risky alcohol and drug use among teens. In this trial, some participants will receive the Chat Intervention, which involves a short, focused conversation aimed at lowering alcohol and drug use in high-risk adolescents. For example, studies have found that this type of intervention can lead to a clear drop in heavy drinking. Another study showed that a brief intervention could help teens with more serious substance use problems over a year. These findings suggest that the Chat Intervention might effectively reduce alcohol use in teens. Meanwhile, other participants in this trial will receive Enhanced Usual Care, which serves as a comparison to evaluate the effectiveness of the Chat Intervention. ^{1 2 3 6 7}

Who Is on the Research Team?

Elizabeth J. D'Amico, PhD

Principal Investigator

RAND

Alina I Palimaru, PhD

Principal Investigator

RAND

Are You a Good Fit for This Trial?

This trial is for diverse teens aged 12-17 who are at risk for alcohol or cannabis use, as indicated by the CRAFFT screening tool. Participants must receive health care from one of two specific health systems to join.

Inclusion Criteria

I am between 12 and 17 years old.

Receive health care at one of two participating health systems

Screen positive for being at risk for alcohol or cannabis use using the CRAFFT

Exclusion Criteria

If they don't meet the inclusion criteria, they will be excluded

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 month

1 visit (in-person or virtual)

Baseline Survey and Intervention Assignment

Teens complete a baseline survey and are assigned to either Enhanced Usual Care or Chat Intervention

1 month

1 visit (in-person or virtual)

Intervention

Participants receive either Enhanced Usual Care or the Chat Intervention

1 month

1 visit (in-person or virtual)

Follow-up

Participants are monitored through web-based surveys at 3, 6, and 12 months after baseline survey completion

12 months

3 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Chat

Trial Overview The study is testing a brief motivational interviewing intervention called Chat against an Enhanced Usual Care approach to see if it can effectively address underage drinking and cannabis use among young people.

How Is the Trial Designed?

Group I: Chat Intervention Experimental Treatment 1 Intervention

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.

Group II: Enhanced Usual Care Active Control 1 Intervention

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 is already approved in United States for the following indications:

Approved in United States as CHAT for:

• Alcohol use disorder prevention in adolescents

Who Is Running the Clinical Trial?

RAND

Lead Sponsor

Trials

145

Recruited

617,000+

University of Pittsburgh Medical Center

Collaborator

Trials

78

Recruited

77,600+

AltaMed Health Services Corporation

Collaborator

Trials

11

Recruited

37,700+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

A pilot study tested a 2-session motivational interviewing intervention for substance use among medical patients aged 14 to 18, highlighting the challenges in recruiting and retaining participants.

Despite these challenges, many participants who completed the intervention reported a reduction in substance use and a decreased risk of driving after drinking over a 3-month follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing for adolescent substance use: a pilot study. Knight, JR., Sherritt, L., Van Hook, S., et al.[2009]

A study involving 506 adolescents showed that motivational interviewing (MI) led to significant reductions in alcohol use over 12 months, slightly outperforming alcohol and cannabis education (ACE).

Both MI and ACE effectively reduced cannabis use, with no significant differences between the two groups, indicating that MI's culturally adaptive approach is beneficial for diverse youth populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term RCT outcomes for adolescent alcohol and cannabis use within a predominantly Hispanic sample. Dash, GF., Bryan, AD., Montanaro, E., et al.[2023]

A brief motivational interviewing (MI) intervention was successfully implemented with 573 adolescents in a randomized controlled trial, showing it can be a practical addition to school-based substance abuse prevention programs.

The MI intervention was delivered with adequate fidelity, indicating that it can be effectively integrated into existing programs to potentially enhance their impact on preventing substance abuse among high school students.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Boosting a teen substance use prevention program with motivational interviewing. Barnett, E., Spruijt-Metz, D., Unger, JB., et al.[2021]

Motivational interviewing (MI) delivered during emergency care is at least as effective as control interventions in reducing alcohol consumption among young people, based on a systematic review of six trials with 1433 participants aged 13-25.

The analysis showed that MI significantly decreased both the frequency and quantity of alcohol consumption, particularly in high-volume drinkers, suggesting it may be a valuable intervention for risky drinking behaviors in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can motivational interviewing in emergency care reduce alcohol consumption in young people? A systematic review and meta-analysis. Kohler, S., Hofmann, A.[2018]

A study involving 101 first-time adolescent offenders showed that a six-session motivational interviewing (MI) group intervention, called Free Talk, was well-received and effective in engaging participants.

Feedback from the sessions indicated high levels of key MI components such as evocation, collaboration, and empathy, suggesting that this approach is acceptable and beneficial for at-risk youth dealing with alcohol and drug offenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Group Motivational Interviewing Intervention for Adolescents At-Risk for Developing an Alcohol or Drug use Disorder. D'Amico, EJ., Osilla, KC., Hunter, SB.[2021]

A group motivational interviewing (MI) intervention targeting at-risk youth in a teen court setting showed promising results, with both AOD use and delinquency decreasing for participants in both the MI and usual care groups over 3 months.

Participants in the Free Talk group, which utilized a group MI approach, reported higher satisfaction and quality ratings, suggesting that MI may enhance engagement compared to standard care, although long-term outcomes need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a group motivational interviewing intervention for adolescents with a first time alcohol or drug offense. D'Amico, EJ., Hunter, SB., Miles, JN., et al.[2022]

A randomized trial involving 69 American Indian and Alaska Native youth showed that both Motivational Interviewing (MI) and Psycho-Education (PE) significantly reduced the quantity and frequency of drinking among those already consuming alcohol, with MI particularly benefiting male drinkers.

The interventions also helped prevent underage drinking initiation, as only 17% of non-drinkers started drinking by follow-up, highlighting the effectiveness of these approaches in addressing underage drinking in this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized trial of Motivational Interviewing compared to Psycho-Education for reducing and preventing underage drinking in American Indian adolescents. Gilder, DA., Geisler, JR., Luna, JA., et al.[2018]

Motivational Interviewing (MI) has been shown to be effective in reducing substance use among adolescents, with 67% of the 39 studies reviewed reporting significant improvements in outcomes.

The review found no significant differences in effectiveness between MI interventions that included feedback or were combined with other treatments compared to those that used MI alone, highlighting the need for further research into the mechanisms that drive these changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational Interviewing for adolescent substance use: a review of the literature. Barnett, E., Sussman, S., Smith, C., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3826597/

A Randomized Controlled Trial of a Group Motivational ... Group Motivational Interviewing (MI) interventions that target youth at-risk for alcohol and other drug (AOD) use may prevent future negative consequences.

2. crimesolutions.ojp.gov crimesolutions.ojp.gov/chat-motivational-interviewing-adolescents-risk-substance-use

CHAT (Motivational Interviewing for Adolescents At-Risk for ... To reduce adolescent alcohol and other drug use, CHAT uses motivational interviewing ... Outcomes were defined as drinking, heavy drinking, marijuana use ...

3. plataformadeevidencias.iadb.org plataformadeevidencias.iadb.org/en/casos-avaliados/chat-motivational-interviewing-adolescents-risk-substance-use

CHAT (Motivational Interviewing for Adolescents At Risk ... An impact evaluation found no statistically significant differences in alcohol or cannabis use; however, there was a statistically significant reduction in the ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0740547207002437

Brief motivational interviewing for teens at risk of substance ... The current study examined the impact of a brief motivational interviewing (MI) intervention (Project CHAT) on alcohol consumption and drug use for high-risk ...

5. publications.aap.org publications.aap.org/pediatrics/article/144/2/e20183014/38537/Understanding-Which-Teenagers-Benefit-Most-From-a

Understanding Which Teenagers Benefit Most From a Brief ... A 15-minute intervention in PC can benefit adolescents with more severe alcohol and marijuana use 1 year later compared with UC.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6110093/

Brief motivational interviewing intervention to reduce ... Table 1 shows that 91% of adolescents were satisfied with the CHAT session and 92% thought the quality of the discussion was good or excellent. Eighty-five ...

7. researchgate.net researchgate.net/publication/267753364_Group_Motivational_Interviewing_for_Adolescents_Change_Talk_and_Alcohol_and_Marijuana_Outcomes

(PDF) Group Motivational Interviewing for Adolescents Outcomes included past-month intentions, frequency, and consequences of alcohol and marijuana use; motivation to change; and positive ...