Clinical trial NCT02502799: Intervention for Teens With ADHD and Substance Use
Official title: Intervention for Teens With ADHD and Substance Use
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Florida International University
Sponsor class: OTHER
First posted: 2015-07-20
Enrollment: 158
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The goal of this study is to evaluate the efficacy of a brief early intervention (BEI) for reducing early alcohol and marijuana use in a group of 300 adolescents (age 12-16) with ADHD. All adolescents will receive the BEI based on the Teen Intervene program with the addition of enhanced decision making skills. Due to the existing support for the intervention and concern for randomizing families with adolescents at risk for worsening substance use outcomes into a control (no treatment) condition for one to two years, no control condition is used in the current design at the first level of intervention. Similarly, due to the time required to see a potential effect of the treatment (6 months post-brief intervention), a wait-list control condition was not considered.

Adolescents will be evaluated for treatment non-response at 6, 9, 12, 15, and 18 months post-treatment. Non-response is defined as non-normative use of alcohol, marijuana, or other drugs during the past 90 days. Tobacco products are excluded from consideration. Adolescents who demonstrate non-response to the initial BEI at any of the follow-up assessments will be randomized to one of the following conditions: 1) Continued monitoring of substance use with no additional treatment 2) Parent training and adolescent cognitive behavioral therapy (PT/ACBT) 3) PT/ACBT plus concurrent stimulant medication (PT/ACBT + MED). Participants who are randomized will be assessed at 6 months post-treatment and again one year later. The difference in days of substance use at the follow-up assessments among the three conditions will inform which type of intervention is best for youth who do not respond to the initial BEI.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Past 90-day Alcohol Use
timeFrame: Assessed at 6 months after randomization to treatment
measure: Number of Participants With Evidence of Illicit Substances in Urine Screen
timeFrame: Assessed at 6 months after randomization to treatment
Secondary outcomes:
measure: Mean Youth-Report of Parent-adolescent Conflict
timeFrame: Assessed at 6 months after randomization to treatment
measure: Mean Youth Self-Report of Disruptive Behaviors
timeFrame: Assessed at 6 months after randomization to treatment
measure: Mean Youth Self-Report of Likelihood of Future Substance Use
timeFrame: Assessed at 6 months after randomization to treatment
measure: Mean Youth Self-Report of Functional Impairment
timeFrame: Assessed at 6 months after randomization to treatment
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University Center for Children and Families
state: Florida
Study officials:
affiliation: Florida International University
name: William E Pelham, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winters KC, Leitten W. Brief intervention for drug-abusing adolescents in a school setting. Psychol Addict Behav. 2007 Jun;21(2):249-54. doi: 10.1037/0893-164X.21.2.249.