TerminatedPhase 3

Intervention for Teens With ADHD and Substance Use

United States158 participantsStarted 2015-07

Plain-language summary

Individuals with ADHD are at markedly high risk for increased substance use and Substance Use Disorder (SUD). Given the strong evidence for the negative trajectory of individuals with co-occurring ADHD and substance use initiation, the goal of this study is to conduct a controlled examination of a brief, early intervention (BEI) for substance modified for adolescents with ADHD. Importantly, this intervention will address individuals who are at risk for problems with substance use, but do not yet meet criteria for severe SUD. Although brief interventions have been found to be effective in other populations, their efficacy in an ADHD population with emerging risk for substance use problems remains uninvestigated. This study aims to understand why some adolescents with ADHD and elevated risk for SUD respond to (BEI) and others do not. The investigators will test whether situational and individual characteristics predict substance use development and response to treatment. Further, this study will assess which types of additional treatment are most effective for youth who do not respond to the initial BEI. It is hypothesized that rates of adolescent substance use will be lower among adolescents who participate in study treatments.

Who can participate

Age range

12 Years – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of ADHD * At elevated risk for substance use problems as evidenced by at least one general risk factor (e.g., elevated symptoms of ODD or CD, elevated conflict with parents, low parental monitoring, or academic failure) and at least one substance use specific risk factor (e.g., non-normative use of alcohol or other drugs, use of cigarettes or e-cigarettes, parental substance use problems, family history of substance use problems, peer or sibling substance use). Exclusion Criteria: * IQ \< 80 * Current substance use disorder meeting DSM-IV criteria for the severe qualifier * Psychotropic medications for ADHD or any other condition * Active medical conditions that could be worsened by stimulants unless approved for participation by the treating physician * Diagnosis of bipolar disorder, schizophrenia, and/or other psychotic disorder * Diagnosis of autism spectrum disorder (ASD) with a severity level of 2 or 3 or significant intellectual or language impairment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Past 90-day Alcohol Use

Timeframe: Assessed at 6 months after randomization to treatment

Number of Participants With Evidence of Illicit Substances in Urine Screen

Timeframe: Assessed at 6 months after randomization to treatment

Trial details

NCT IDNCT02502799

SponsorFlorida International University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08

Results submitted2022-11-15

View on ClinicalTrials.gov More Attention Deficit Hyperactivity Disorder trials