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Alcohol UseNCT06593652

Evaluating Caregiver Involvement in Primary Care-Based Brief Interventions for Adolescent Alcohol Use Problems

A study testing Teen Intervene - Adolescent Only, Teen Intervene with Caregiver Session and Family Check Up in people with Alcohol Use and Adolescent, run by Indiana University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Intervention for mild severity alcohol use among U.S. teens is crucial, as alcohol is the most commonly used substance in this age group, yet few receive the necessary interventions. Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Alcohol Use, Adolescent, Mild Alcohol Use Disorder
What is being tested?
Teen Intervene - Adolescent Only, Teen Intervene with Caregiver Session and Family Check Up
Could I receive a placebo?
No, everyone receives an active treatment
How many people
615 participants
Where
1 siteUnited States
Study dates
19 Aug 2025to Sep 2028
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 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 12-18 years old;
  • Mild to moderate severity for substance use (based on screeners such as AUDIT, CUDIT, BSTAD, KCAT SUD, S2BI, CRAFFT, etc.)
  • English language fluency

Who cannot join

  • N/A

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

SPARC Research Team contact

(317) 274-7715

sparc@iu.edu

Zachary Adams, PhD, HSPP contact

317-278-0591

zwadams@iu.edu

United States1 site, 1 recruiting
  • IU Health/Indiana University School of Medicine

    Indianapolis, Indiana, 46112

    SPARC Research Team, (317) 274-7715, sparc@iu.edu

    Zack Adams, PhD, HSPP

    Recruiting

Other trials in United States

About this study

Intervention for mild severity alcohol use among U.S. teens is crucial, as alcohol is the most commonly used substance in this age group, yet few receive the necessary interventions. Primary care, where over 90% of youth regularly visit, is an ideal setting for identifying and addressing mild alcohol use disorder (AUD) through brief interventions like motivational interviewing (MI) and cognitive-behavioral therapy (CBT). However, for teens with mild AUD, a single brief session may not be sufficient, raising questions about the role of caregiver involvement. This study seeks to determine the most effective level of caregiver involvement-no involvement, a single live session, or an online self-paced program-in reducing alcohol use or other substance use among adolescents with mild AUD/SUD in primary care/adolescent clinic settings. The study also explores the impact of these interventions on other outcomes such as substance use, psychosocial functioning, behavioral health services engagement, as well as the factors influencing treatment response. The results will guide the selection and implementation of effective, scalable interventions in primary care to address youth alcohol use and other substance use disorders.

Read the detailed description

Detailed Description

Intervention for mild severity alcohol use is needed in primary care. Alcohol is the most commonly used substance among U.S. teens (lifetime use: 62% of 12th graders) and contributes to myriad harms, yet few youth who may benefit from intervention ever receive it. Primary care is an ideal setting for identifying and delivering brief interventions to youth with mild severity alcohol problems since over 90% of youth attend primary care visits routinely and substance use screening is standard practice. For youth with infrequent, low-risk use, brief (15-30 minute) motivational conversations may be sufficient to reduce risk. In contrast, youth with moderate to severe alcohol problems typically require more intensive interventions delivered by behavioral health specialists (e.g., intensive outpatient, residential treatment). A critical decision faced in primary care settings is what to do for youth who fall between these ends of the spectrum-namely, youth who show early signs of problematic use, meeting criteria for mild severity alcohol use disorder (AUD) (i.e., 2-3 symptoms; estimated to be approximately 3% of youth aged 12-17). Strong evidence supports individual-level brief interventions that incorporate motivational interviewing (MI) and basic cognitive-behavioral therapy (CBT) skills to help youth reduce substance use frequency, volume, and related impairment among youth with mild AUD.

Caregiver involvement in brief interventions for mild severity AUD may improve outcomes. Systematic reviews support interventions that address family-level factors (e.g., parents' attitudes, parenting behavior). When and how to involve parents or other primary caregivers in interventions for youth with mild severity AUD remains unclear. For instance, in a large school-based trial, brief MI+CBT without a caregiver session was equivalent to brief MI+CBT with a caregiver session on alcohol outcomes and drug consequences, whereas the MI+CBT with a caregiver session modestly outperformed the adolescent-only condition on cannabis-related outcomes.

Directly intervening with caregivers can be difficult and impractical. Despite the potential benefits of caregiver involvement, many caregivers see their child's behavior and choices as the main concern and therefore may be less inclined to participate in services focused exclusively on parenting practices. Caregivers may also have to miss work for parenting-dedicated sessions, which can disproportionately impact economically disadvantaged families. Asynchronous online programming may address some of these barriers-and preliminary findings support acceptability and efficacy of this approach-but such programs remain understudied relative to more traditional program structures. Identifying the relative effectiveness of online versus in-person caregiver components compared to youth-only interventions is critical to support decisions and eventual cost-benefit analyses about which programs to offer to different patients.

The primary research question this study aims to address is, "What type and level of caregiver involvement in a brief youth-focused intervention (i.e., Teen Intervene) results in the greatest reductions in alcohol and other substance use among adolescents with mild alcohol use disorder/ substance use disorder when delivered in a primary care/other adolescent clinic context: no caregiver involvement, a single dedicated parent session, or a self-paced online parenting program?" Secondary research questions are "What is the relative impact of the three intervention models on other substance, academic, and behavioral health outcomes?" and "Do youth (i.e., personality, alcohol/substance risk perceptions, etc.) and family factors (i.e., parental monitoring) moderate treatment response?" Understanding implementation factors associated with each intervention is also of interest, as engaging caregivers in youth SUD services can be challenging. Thus, the outcomes of the current project will help inform the selection and delivery of interventions that are both effective and reasonable to implement in primary care contexts, where most youth receive healthcare services. When delivered at scale, such interventions could help address the alcohol and other substance use disorders affecting the U.S. today.

Specific Aims

A Type 1 hybrid effectiveness-implementation trial is proposed to compare the effectiveness of an individual skill-building MI+CBT brief intervention (Teen Intervene, TI) with varying caregiver involvement: a) no caregiver involvement, b) a single live caregiver session, and c) an online, self-paced parenting program (Family Check-Up Online, FCU). These brief intervention programs will be tested as a first-level intervention to address mild SUD and prevent progression to more severe AUD/SUD symptoms or patterns of use. The aims are two-fold:

Aim 1: Compare the effectiveness of a youth-focused brief intervention (TI) when delivered without caregiver involvement (TI-A) versus with an added caregiver session (TI-A+P) versus with an online caregiver component (TI-A+FCU) in reducing substance use in adolescents with mild AUD/SUD in primary care. The overall magnitude of response and percentage of youth in each condition with clinically meaningful changes (i.e., % responders) will be measured. It is predicted that TI-A+P > TI-A+FCU > TI-A. Secondary outcomes will include AUD/SUD symptoms, general psychosocial functioning, engagement in youth behavioral health services.

Aim 2: Identify youth and family factors associated with intervention response versus non-response in each treatment condition, such as baseline substance use intensity (frequency, volume, duration, type), youth and caregiver perception of substance use risk, youth personality factors (impulsivity, emotion dysregulation), and baseline parenting practices. Intervention implementation factors will also be examined. This aim will be accomplished through both quantitative and qualitative measures.

Being tested
Teen Intervene - Adolescent Only, Teen Intervene with Caregiver Session, Family Check Up
Keywords
Brief Intervention, Teen Intervene, Caregiver Involvement, Alcohol Use, Substance Use
Medical subject headings
Alcohol Drinking, Substance-Related Disorders

What participants receive

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

  • Teen Intervene - Adolescent OnlyBehavioural

    Teen Intervene (TI) is delivered over two or three, 45- to 60-minute sessions (2 teen sessions +/- 1 caregiver session) to reduce youth substance use, increase motivation for abstinence, and promote use of existing coping strategies. TI is an adolescent-appropriate adaptation of motivational enhancement therapy (MET), and includes a discussion of readiness to change, goal setting, personal feedback, a functional analysis of substance use, and a review of coping skills.

  • Teen Intervene with Caregiver SessionBehavioural

    Teen Intervene (TI) is delivered over two or three, 45- to 60-minute sessions (2 teen sessions +/- 1 caregiver session) to reduce youth substance use, increase motivation for abstinence, and promote use of existing coping strategies. TI is an adolescent-appropriate adaptation of motivational enhancement therapy (MET), and includes a discussion of readiness to change, goal setting, personal feedback, a functional analysis of substance use, and a review of coping skills. In this condition, the caregiver session will address caregiver expectations around youth substance use and strategies for promoting positive youth behavior change including reduced substance use.

  • Family Check UpBehavioural

    Family Check-Up Online (FCU-O) is a self-paced, parent-driven, fully HIPAA compliant online version of the Family Check-Up (FCU), a brief intervention that integrates assessment, motivation-enhancement, and skill building to help parents effectively manage behavior and build positive relationships with their children aged 2-17 in order to reduce emotional and behavioral problems among youth.

Study groups in NCT06593652
Study groupRoleWhat they receive
Teen Intervene - Adolescent OnlyActive comparatorOnly the youth will participate in brief intervention, Teen Intervene (3 sessions). The youth will participate in manual-standardized Teen Intervene sessions.
Receives: Behavioral: Teen Intervene - Adolescent Only
Teen Intervene - Caregiver InvolvementExperimentalThe youth will participate in three Teen Intervene sessions. Additionally, the caregiver(s) will participate in a single, caregiver-only Teen Intervene session.
Receives: Behavioral: Teen Intervene with Caregiver Session
Teen Intervene - Online Caregiver Support ToolExperimentalOnly the youth will participate in the brief intervention, Teen Intervene. The youth will participate in three Teen Intervene sessions. Caregiver(s) will be provided with an online tool (Family Checkup Online) that addresses parenting strategies to support their youth.
Receives: Behavioral: Family Check Up

What is being measured

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

  1. Timeline Follow-Back

    Primary outcome: 30 items that assess daily alcohol usage over the past month will be administered to all participants. Participants will be queried about # of use days, # drinks/times, # binge episodes for 30 days.

    Measured: *0-at time of baseline, post intervention, *3 months after baseline; *6 months after baseline; *9 months after baseline; *12 months after baseline

  2. Timeline Follow-Back

    Co-primary outcome: 30 items that assess daily substance (cannabis, nicotine, and other illicit substances) usage over the past month will be administered to all participants. Participants will be queried about #of use days, #times, #binge episodes for 30 days.

    Measured: *0-at time of baseline, post-intervention; *3 months after baseline; *6 months after baseline; *9 months after baseline; *12 months after baseline

Secondary outcomes (6)
  1. DAST

    28 items that review drug use symptoms will be administered to all participants.

    Measured: *0-at time of baseline, post-intervention; *3 months after baseline; *6 months after baseline; *9 months after baseline; *12 months after baseline

  2. Youth Services Engagement

    2 items that review youth services received by the participant (e.g., mental health treatment, substance use treatment, hospitalization) over the past 3 months per caregiver report. This will be asked to all participant caregivers.

    Measured: *0-at time of baseline, *3 months after baseline; *6 months after baseline; *9 months after baseline; *12 months after baseline

  3. PROMIS Surveys

    37 items that review Psychosocial Functioning (Peer Relationships, Life Satisfaction, Depression, Anxiety, Anger/Irritability, and Psychological Stress Experiences). These items will be administered to all participants.

    Measured: *0-at time of baseline, post-intervention; *3 months after baseline; *6 months after baseline; *9 months after baseline; *12 months after baseline

  4. AUDIT for Teen

    12 item measure used to assess alcohol consumption levels among adolescents.

    Measured: *0-at time of baseline, post-intervention; *3 months after baseline; *6 months after baseline; *9 months after baseline; *12 months after baseline

  5. DUDIT for Teen

    11 item measure used to assess level of drug use among adolescents

    Measured: *0-at time of baseline, post-intervention; *3 months after baseline; *6 months after baseline; *9 months after baseline; *12 months after baseline

  6. CUDIT for Teen

    8 item measure used to assess cannabis misuse among adolescents

    Measured: *0-at time of baseline, post-intervention; *3 months after baseline; *6 months after baseline; *9 months after baseline; *12 months after baseline

Timeline

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

  1. First posted19 Sep 2024
  2. Study start19 Aug 2025
  3. Primary completionSep 2028 (estimated)
  4. Study completionSep 2028 (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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
615 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06593652
Sponsor's protocol ID
23394
Status last verified
Oct 2025
First submitted
28 Aug 2024
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Though the researchers are not required to provide information about plans to share individual participant data (IPD), we plan to withhold individual participant data from sharing. This decision aligns with university policy and the terms outlined in our participants\' consent forms, which stipulate that patient information will not be shared publicly.

Questions about this trial

What is this clinical trial studying?

A study testing Teen Intervene - Adolescent Only, Teen Intervene with Caregiver Session and Family Check Up in people with Alcohol Use and Adolescent, run by Indiana University at 1 site in United States.

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 3 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 SPARC Research Team ((317) 274-7715, sparc@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Timeline Follow-Back (time frame: *0-at time of baseline, post intervention, *3 months after baseline; *6 months after baseline; *9 months after baseline; *12 months after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 28 Oct 2026.

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