AzTrials
AzTrials

Initation of Substance Use DisorderNCT07074860

Clinical Screening and Peer Interventions to Prevent Substance Use in At-Risk Adolescents

A study testing Peer to peer video to raise awareness about substance use in people with Initation of Substance Use Disorder, run by University of Vermont.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical trial is to test a method of preventing substance use among adolescents. Young people aged 11-14 who have depression, anxiety, or attention deficit hyperactivity disorder (ADHD) are at higher than usual risk for starting substances such as alcohol, tobacco products, or drugs. Read more about this study

Who is it for?
Ages 11 to 14 years
Conditions the study is for
Initation of Substance Use Disorder
What is being tested?
Peer to peer video to raise awareness about substance use
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
Sep 2025to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Diagnosis of depression, anxiety, or ADHD

Who cannot join

  • Has not initiated substance use

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Constance van Eeghen, DrPH contact

802-373-6286

cvaneegh@med.uvm.edu

Michelle Shephard, MD, PhD contact

802-847-2700

michelle.shepard@med.uvm.edu

About this study

The goal of this clinical trial is to test a method of preventing substance use among adolescents. Young people aged 11-14 who have depression, anxiety, or attention deficit hyperactivity disorder (ADHD) are at higher than usual risk for starting substances such as alcohol, tobacco products, or drugs. The main question the investigators aim to answer is:

"Will watching short videos in their doctor's office every three months that were made by other adolescents in their community about not using drugs and other substances prevent at risk adolescents from starting to use those substances?"

The investigators will measure the outcome by asking participants to complete a survey every three months. The survey is a standard set of questions about behavior, including substance use. If they have started to use substances, they will get treatment for substance use. If they have not, they will watch another video and come back three months later to repeat the survey.

Read the detailed description

Adolescent substance use is a significant public health concern with self-reported use of drugs and/or alcohol remaining high in the United States. Data from the National Survey on Drug Use and Health show that adolescent initiation of alcohol and cannabis use in the past year was 9.1% and 5.4% respectively. Evidence suggests that earlier initiation of substance use is linked to higher rates of substance use disorder (SUD) in adulthood. The American Academy of Pediatrics (AAP) recommends substance use screening for adolescents beginning at age 11 at annual health supervision visits. The Substance Abuse and Mental Health Services Administration (SAMHSA) also provides recommendations on screening for adolescent substance use using validated screening tools. Validated tools for adolescent substance use screening are available to primary care providers (PCPs) to administer to patients at health supervision visits. To use these resources effectively, practices are encouraged to have a pathway for administering screening tools and addressing responses. The screening, brief intervention, and referral to treatment (SBIRT) model is recommended as the ideal clinician response to positive screening. Negative screens for substance use generally are addressed with motivational interviewing but might not be discussed during a busy health supervision visit if there are other concerns to address. Furthermore, PCP delivered brief interventions have been shown to have mixed results providing some benefit in decreasing heavy alcohol use, but not cannabis use or abstinence.

Several common mental health diagnoses are associated with increased risk of adolescent substance use including depression, anxiety, and attention deficit hyperactivity disorder (ADHD). Adolescents receiving treatment for these diagnoses from their PCP often have frequent office visits ranging from monthly to quarterly. Screening and assessment tools are often utilized to both diagnose and monitor response to treatment for these conditions. Commonly used tools include the Patient Health Questionnaire 9 (PHQ-9) modified for teens for depression, Generalized Anxiety Disorder 7 (GAD-7) for anxiety, and NICHQ Vanderbilt scales for ADHD. Currently, there are no recommendations to screen more frequently for substance use in adolescents with depression, anxiety and/or ADHD despite their increased risk of developing SUD.

Recent Interventions: Many interventions for adolescent substance use prevention have been developed and studied. A recent study found that computer-based screening of adolescents for alcohol and cannabis followed by a brief educational intervention decreased risk behaviors in those reporting current use, but no benefit in those reporting no use. This study provided adolescents with immediate calculation of their reported use followed by multiple pages of scientific data and vignettes, focusing on decreasing risky use and riding with an impaired driver. However, a recent meta-analysis of primary prevention programs including Life Skills Training and other models, have demonstrated variable results and benefits. Similarly, meta-analysis of school-based interventions for alcohol and cannabis use in adolescents provided low or very-low quality evidence of effectiveness. Brief interventions targeting adolescents with depression and anxiety have not shown clear benefits in decreasing substance use, in part due to variability of models and interventions evaluated. Each of these studies concluded more research was needed to determine effectiveness of individual models in decreasing risk behaviors or preventing substance use.

Peer-based interventions have shown utility for improving adolescent engagement and participation in their health care, including the Providers and Teens Communicating for Health (PATCH) program. Studies of similar programs provide supporting evidence. One study examined a peer support service for youth experiencing complex challenges with mental health, physical health and/or substance use to better understand key features and underlying mechanisms that lead to improved client outcomes, noting the importance of mechanisms related to 1) positive identity development through identification with peers, 2) enhanced social connections, 3) observational learning and 4) enhanced autonomy and empowerment. Another looked at the direct relation between positive peer affiliation and substance use, and whether positive peer affiliation moderated the relation between self-reported sensation-seeking, future orientation, self-regulation and substance use, finding that having friends who generally engage in positive activities is an important buffer against socioemotional risk factors. Building on previous research, another examined the relationship of positive peer influence with indices of substance use and compared abstinent adolescents and substance-using adolescents on positive peer influence, with the results identifying positive peer influence as a significant predictor of lower substance use behaviors in adolescents and with positive influence from close friends being the strongest predictor. These findings, while hopeful, have been shown to need more study in sub-group analysis, as results vary by gender and other characteristics.

Looking more specifically at studies that examine the impact of peer-based interventions on prevention of substance use in adolescents, a systematic review of the literature on prevention of substance initiation for ages 11-21 showed peer-led interventions were associated with benefit in relation to alcohol use (OR = 0.80, 95% CI = 0.65-0.99, P = 0.036), while three studies ( n = 976 students in 38 schools) suggested an association with lower odds of cannabis use (OR = 0.70, 0.50-0.97, P = 0.034)17. Additional studies confirmed the value of this approach, with sometimes mixed results in sub-group analysis.

Proposed Model: Clinical Screening and Peer Interventions to Prevent Substance Use in At-Risk Adolescents: The investigators propose trialing an intervention focused on prevention of substance use among adolescents aged 11-14 at increased risk due to depression, anxiety, or ADHD diagnoses and who have not initiated substance use. These at-risk patients are routinely scheduled for regular follow-up visits with their PCPs for management of their mental health diagnoses. With our model, they will be rescreened for substance use quarterly (rather than annually) to promote more frequent conversations about prevention with their providers. They will receive access to brief video modules about avoiding substance use made by local peers.

This model is based on the novel use of clinical screening to identify at-risk adolescents not using substances for peer-led interactions. The use of video modules for substance use prevention is well-supported in the literature, as are social media awareness campaigns and media literacy for adolescents. Recently, the American Psychological Association issued recommendations for skill training for adolescents "to ensure that youth have skills that will maximize the chances for balanced, safe and meaningful experiences" using social media. The proposed intervention provides more frequent screening for substance use initiation to promote more frequent conversations about prevention with their providers and access to brief video modules about avoiding substance use made by local peers.

The primary objective of this study is to develop and trial an intervention of peer-designed and peer-delivered videos focused on prevention of substance use for adolescents aged 11-14 who have diagnosed depression, anxiety, or ADHD and who have not initiated substance use.

The secondary objective is to obtain user feedback on the videos for later development in a larger study.

Being tested
Peer to peer video to raise awareness about substance use
Keywords
Substance use prevention, Peer to peer support for adolescents, Video-based awareness raising

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peer to peer video to raise awareness about substance useBehavioural

    A total of 4 short, animated videos will be created using design concepts and language created by the VT RAYS. Each video will be <2 minutes in length and address a specific topic including e-cigarette, cannabis, alcohol and other substance use. These videos will be curated online and shown to study participants during their scheduled primary care visits. The video will be followed by a short online survey available immediately after viewing to collect feedback on the content.

Study groups in NCT07074860
Study groupRoleWhat they receive
Peer to peer videoExperimentalThis study involves the pilot testing of novel substance use prevention videos, which are in the process of being developed for this study by a local group of adolescents that have created teen-focused public health messaging.
Receives: Behavioral: Peer to peer video to raise awareness about substance use

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CRAFFT 2.1 Questionnaire total score

    The CRAFFT 2.1 questionnaire is a substance use screening tool for pediatric patients age 11 and older. It is recommended by the US Preventative Services Task Force and American Academy of Pediatrics and has been validated for use in adolescents.

    Measured: Up to 12 months after enrollment

Secondary outcomes (1)
  1. Video Feedback Survey

    4 items scored on a Likert Scale (Strongly disagree to Strongly agree) assessing whether the video provided new information, was interesting, was recommended for others of the same age, and whether the participant felt comfortable talking to their healthcare provider about using alcohol and drugs.

    Measured: Up to 12 months after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2025
  2. Study startSep 2025 (estimated)
  3. Primary completionMar 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07074860
Sponsor's protocol ID
STUDY00003562
Other IDs
AWD00001448
Status last verified
Jul 2025
First submitted
1 Jul 2025
Last updated
20 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This is a pilot study for proof of concept. The tertiary purpose of the study is to support a larger test of the intervention, if found beneficial.

Publications

  • Winn LAP, Paquette KL, Donegan LRW, Wilkey CM, Ferreira KN. Enhancing adolescent SBIRT with a peer-delivered intervention: An implementation study. J Subst Abuse Treat. 2019 Aug;103:14-22. doi: 10.1016/j.jsat.2019.05.009. Epub 2019 May 14.

    PubMed 31229188
  • Giambra, D.M., Adolescent peer support groups to reduce risky behaviors. Dissertation Abstracts International: Section B: The Sciences and Engineering. Vol. 83(5B). 2022

  • Mitchell SG, Kelly SM, Gryczynski J, Myers CP, O'Grady KE, Kirk AS, Schwartz RP. The CRAFFT cut-points and DSM-5 criteria for alcohol and other drugs: a reevaluation and reexamination. Subst Abus. 2014;35(4):376-80. doi: 10.1080/08897077.2014.936992.

    PubMed 25036144
  • Knight JR, Sherritt L, Shrier LA, Harris SK, Chang G. Validity of the CRAFFT substance abuse screening test among adolescent clinic patients. Arch Pediatr Adolesc Med. 2002 Jun;156(6):607-14. doi: 10.1001/archpedi.156.6.607.

    PubMed 12038895
  • Greene K, Ray AE, Choi HJ, Glenn SD, Lyons RE, Hecht ML. Short term effects of the REAL media e-learning media literacy substance prevention curriculum: An RCT of adolescents disseminated through a community organization. Drug Alcohol Depend. 2020 Sep 1;214:108170. doi: 10.1016/j.drugalcdep.2020.108170. Epub 2020 Jul 10.

    PubMed 32693198
  • Kupersmidt JB, Scull TM, Benson JW. Improving media message interpretation processing skills to promote healthy decision making about substance use: the effects of the middle school media ready curriculum. J Health Commun. 2012;17(5):546-63. doi: 10.1080/10810730.2011.635769. Epub 2012 Feb 16.

    PubMed 22339322
  • Park E, Jang BG. Youth Substance Use Prevention Using Disciplinary Literacy Strategies: A Pilot Study. J Addict Nurs. 2018 Oct/Dec;29(4):235-243. doi: 10.1097/JAN.0000000000000253.

    PubMed 30507819
  • Wang, T.-C., F.-C. Chang, C.-H. Lee, H.-Y. Chi, L.-J. Huang, and C.-C. Tseng, Adolescents' misperceptions and low literacy associated with the inappropriate use of over-the-counter cold medicines. Journal of Substance Use, 2020. 25(1): p. 101-106

  • Kaestle CE, Chen Y, Estabrooks PA, Zoellner J, Bigby B. Pilot evaluation of a media literacy program for tobacco prevention targeting early adolescents shows mixed results. Am J Health Promot. 2013 Jul-Aug;27(6):366-9. doi: 10.4278/ajhp.120221-ARB-105. Epub 2013 Mar 4.

    PubMed 23458374
  • Primack BA, Douglas EL, Land SR, Miller E, Fine MJ. Comparison of media literacy and usual education to prevent tobacco use: a cluster-randomized trial. J Sch Health. 2014 Feb;84(2):106-15. doi: 10.1111/josh.12130.

    PubMed 25099425
  • Shensa A, Phelps-Tschang J, Miller E, Primack BA. A randomized crossover study of web-based media literacy to prevent smoking. Health Educ Res. 2016 Feb;31(1):48-59. doi: 10.1093/her/cyv062. Epub 2015 Dec 16.

    PubMed 26675176
  • Bier MC, Zwarun L, Sherblom SA. Evidence of the Value of the Smoking Media Literacy Framework for Middle School Students. J Sch Health. 2016 Oct;86(10):717-25. doi: 10.1111/josh.12425.

    PubMed 27619762
  • Bonar EE, Bauermeister JA, Blow FC, Bohnert ASB, Bourque C, Coughlin LN, Davis AK, Florimbio AR, Goldstick JE, Wisnieski DM, Young SD, Walton MA. A randomized controlled trial of social media interventions for risky drinking among adolescents and emerging adults. Drug Alcohol Depend. 2022 Aug 1;237:109532. doi: 10.1016/j.drugalcdep.2022.109532. Epub 2022 Jun 11.

    PubMed 35759874
  • Bonyani A, Safaeian L, Chehrazi M, Etedali A, Zaghian M, Mashhadian F. A high school-based education concerning drug abuse prevention. J Educ Health Promot. 2018 Jul 6;7:88. doi: 10.4103/jehp.jehp_122_17. eCollection 2018.

    PubMed 30079359
  • Hopson L, Wodarski J, Tang N. The effectiveness of electronic approaches to substance abuse prevention for adolescents. J Evid Inf Soc Work. 2015;12(3):310-22. doi: 10.1080/15433714.2013.857178. Epub 2015 Jan 28.

    PubMed 25661894

Questions about this trial

What is this clinical trial studying?

A study testing Peer to peer video to raise awareness about substance use in people with Initation of Substance Use Disorder, run by University of Vermont.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Constance van Eeghen, DrPH (802-373-6286, cvaneegh@med.uvm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CRAFFT 2.1 Questionnaire total score (time frame: Up to 12 months after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07074860, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in