Intervention for Teens With ADHD and Substance Use

Phase 3

Terminated

Conditions: Attention Deficit Hyperactivity Disorder

Interventions: Behavioral: Brief Early Intervention
Behavioral: Parent Training with Adolescent Cognitive Behavioral Therapy
Drug: Methylphenidate

Registration Number: NCT02502799

Lead Sponsor: Florida International University

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 158

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continued Monitoring and Assessment	Brief Early Intervention	All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. Participants randomized to the continued monitoring and assessment arm will receive no additional intervention. Primary and secondary outcomes will be monitored.
PT with ACBT	Brief Early Intervention	All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. For participants randomized to the PT with ACBT arm, parents will participate in behavioral parent training (PT) and adolescents will participate in cognitive behavioral therapy to reduce substance use (CBT).
PT with ACBT	Parent Training with Adolescent Cognitive Behavioral Therapy	All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. For participants randomized to the PT with ACBT arm, parents will participate in behavioral parent training (PT) and adolescents will participate in cognitive behavioral therapy to reduce substance use (CBT).
PT with ACBT and Methylphenidate	Brief Early Intervention	All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. For participants randomized to the PT with ACBT and Methylphenidate arm, parents will participate in behavioral parent training (PT) and adolescents will participate in cognitive behavioral therapy to reduce substance use (ACBT). Adolescents will also receive methylphenidate.
PT with ACBT and Methylphenidate	Parent Training with Adolescent Cognitive Behavioral Therapy	All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. For participants randomized to the PT with ACBT and Methylphenidate arm, parents will participate in behavioral parent training (PT) and adolescents will participate in cognitive behavioral therapy to reduce substance use (ACBT). Adolescents will also receive methylphenidate.
PT with ACBT and Methylphenidate	Methylphenidate	All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. For participants randomized to the PT with ACBT and Methylphenidate arm, parents will participate in behavioral parent training (PT) and adolescents will participate in cognitive behavioral therapy to reduce substance use (ACBT). Adolescents will also receive methylphenidate.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Past 90-day Alcohol Use	Assessed at 6 months after randomization to treatment	Teen self-report of substance use during the past 90 days
Number of Participants With Evidence of Illicit Substances in Urine Screen	Assessed at 6 months after randomization to treatment	Urine analysis indicates presence of illicit substance(s)

Secondary Outcome Measures

Name	Time	Method
Mean Youth-Report of Parent-adolescent Conflict	Assessed at 6 months after randomization to treatment	Youth report of conflict with parents on the Conflict Behavior Questionnaire. Higher scores reflect higher parent teen conflict. Total score equals the average across item scores (ranging 1 to 5).
Mean Youth Self-Report of Disruptive Behaviors	Assessed at 6 months after randomization to treatment	Adolescent disruptive behaviors as measured by adolescent self-report and parent report on the Deviant Behavior Scale. Total scores on this measure reflect the average item rating across all items. Scores range from zero to 20 with higher scores reflecting self-report of engaging in more frequent deviant behaviors.
Mean Youth Self-Report of Likelihood of Future Substance Use	Assessed at 6 months after randomization to treatment	Youth self-report of likelihood of future substance use during the next year. Score reflects participant report of likelihood of using substances over the next year on a scale from 0 (Definitely will not use) to 10 (Definitely will use).
Mean Youth Self-Report of Functional Impairment	Assessed at 6 months after randomization to treatment	Level of impairment experienced across multiple domains of functioning (e.g., at school, at home, with peers) as measured by adolescent self-report on the Impairment Rating Scale. Total score is the mean item rating on a scale from 0 (No problem) to 6 (Extreme problem). Higher scores are indicative of greater impairment.