Intervention for Teens With ADHD and Substance Use

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Intervention for Teens With ADHD and Substance Use

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02502799
• Other study ID #: DA034731
• Status: Terminated
• Phase: Phase 3
• Start date: July 2015
• Est. completion date: August 2021

Study information

• Verified date: December 2022
• Source: Florida International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 158
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Substance-Related Disorders

Intervention

Behavioral:
• Brief Early Intervention
Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
• Parent Training with Adolescent Cognitive Behavioral Therapy
Participants receive 12 family sessions with individual adolescent, parent, and joint adolescent and parent time. Includes additional parent training in behavioral modification, adolescent and parent contracting, and adolescent decision-making skills.

Drug:
• Methylphenidate
Adolescents will receive methylphenidate.

Locations

Country	Name	City	State
United States	Florida International University Center for Children and Families	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida International University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Past 90-day Alcohol Use	Teen self-report of substance use during the past 90 days	Assessed at 6 months after randomization to treatment
Primary	Number of Participants With Evidence of Illicit Substances in Urine Screen	Urine analysis indicates presence of illicit substance(s)	Assessed at 6 months after randomization to treatment
Secondary	Mean Youth-Report of Parent-adolescent Conflict	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).	Assessed at 6 months after randomization to treatment
Secondary	Mean Youth Self-Report of Disruptive Behaviors	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.	Assessed at 6 months after randomization to treatment
Secondary	Mean Youth Self-Report of Likelihood of Future Substance Use	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).	Assessed at 6 months after randomization to treatment
Secondary	Mean Youth Self-Report of Functional Impairment	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.	Assessed at 6 months after randomization to treatment