SIM-AiR for Alcoholism in Adolescents

(SIMAiR Trial)

JF
Overseen ByJaden Femrite
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SIM-AiR, designed to help teenagers with alcohol use disorder (AUD) improve recovery by focusing on social factors. It aims to help youths understand their social circles and how these affect their recovery. The trial seeks to assess participants' feelings about this approach and whether their feedback changes based on personal and social situations. Teens aged 12-19 who are already receiving outpatient treatment for AUD might be suitable candidates. Participants will try SIM-AiR with their therapist and provide feedback through surveys and interviews. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative research that could shape future AUD treatments.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the SIM-AiR intervention is safe for adolescents?

Research shows that the SIM-AiR treatment for teenagers with alcohol use disorder (AUD) is still under evaluation. Limited information is available about its safety for individuals. However, some important points should be noted. SIM-AiR is not a drug or medicine; it is an interactive program designed to help teens better understand their social surroundings. This approach typically carries fewer risks than medication. As SIM-AiR is part of an early study, researchers are closely monitoring its safety. Participants will share their experiences, aiding researchers in assessing its tolerance. Although solid safety data is not yet available, early-stage programs like SIM-AiR are generally considered low-risk.12345

Why are researchers excited about this trial?

Unlike traditional treatments for adolescent alcoholism, such as counseling and medication, SIM-AiR leverages an innovative approach through a digital treatment module. This approach is unique because it utilizes artificial intelligence to provide personalized support and interventions tailored to each individual's needs. Researchers are excited about SIM-AiR because it offers a flexible, accessible, and potentially more engaging way to support young people in overcoming alcoholism, which could lead to improved outcomes and higher engagement rates compared to conventional therapies.

What evidence suggests that the SIM-AiR intervention is effective for alcoholism in adolescents?

Research has shown that certain treatments can effectively help teenagers with alcohol use disorder (AUD) by addressing social influences on drinking habits. Studies indicate that focusing on social connections can lead to lasting improvements. In this trial, all participants will receive the SIM-AiR treatment module. SIM-AiR is a program designed to help teenagers understand and manage their social identities and relationships, which may aid in long-term recovery. While researchers are still gathering specific data on SIM-AiR, its emphasis on understanding social factors aligns well with successful strategies for treating AUD in teenagers.12367

Who Is on the Research Team?

EA

Emily A Hennessy, PhD

Principal Investigator

Recovery Research Institute; National Center on Youth Prevention, Treatment, & Recovery; Harvard Medical School

Are You a Good Fit for This Trial?

This trial is for adolescents aged 12-19 who are getting outpatient treatment for alcohol use disorder and can speak, read, and understand English. Teens under 18 need a parent to agree for them to join.

Inclusion Criteria

Be able to speak, read, and understand English
Meet criteria for alcohol use disorder (mild to severe) as per the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V)
I am 12 to 19 years old and receiving outpatient addiction treatment.

Exclusion Criteria

Refusal to give informed consent
I am under 18 and do not have a parent willing to give consent for me to join.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the SIM-AiR intervention module during a single treatment session with their clinician

1 session
1 visit (in-person)

Data Collection

Participants complete surveys and interviews to provide feedback on the SIM-AiR module

1-2 weeks
1 visit (in-person or virtual)

Follow-up

Participants are monitored for feedback and adaptation needs for future implementation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • SIM-AiR

Trial Overview

The study is testing SIM-AiR, an interactive tool used during therapy sessions to help teens better understand their social circles and identities. The goal is to see if this approach helps with recovery from alcohol problems.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: SIM-AiRExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials
865
Recruited
1,091,000+

University of Connecticut

Collaborator

Trials
194
Recruited
162,000+

Citations

SIM-AiR for Alcoholism in Adolescents (SIMAiR Trial)

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Practitioner Review: Adolescent alcohol use disorders - PMC

Results suggested that naltrexone is an effective and well-tolerated pharmacological adjunct to psychosocial interventions with alcohol-dependent adolescents.

Psychosocial treatment options for adolescents and young ...

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Effectiveness of brief school-based interventions for adolescents

Across all 17 studies eligible for inclusion, school-based BAIs were associated with significant improvements among adolescents, whereby adolescents in the BAI ...

Epidemiology of Recovery From Alcohol Use Disorder

Approximately 70% of persons with AUD and alcohol problems improve without interventions (natural recovery), and fewer than 25% utilize alcohol- ...

Adolescent exposure to anesthetics may cause alcohol use ...

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Alcohol Use Screening and Intervention Guideline

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