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Intervention for Teens With ADHD and Substance Use

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ClinicalTrials.gov Identifier: NCT02502799
Recruitment Status : Recruiting
First Posted : July 20, 2015
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Florida International University

Tracking Information
First Submitted Date  ICMJE July 15, 2015
First Posted Date  ICMJE July 20, 2015
Last Update Posted Date September 18, 2019
Study Start Date  ICMJE July 2015
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2017)
  • Past 90-day substance use [ Time Frame: Assessed at 6 months after randomization to treatment ]
    Number of days during which substances were used in the past 90 days
  • Evidence of illicit substances in urine screen [ Time Frame: Assessed at 6 months after randomization to treatment ]
    Urine analysis indicates presence of illicit substance(s)
Original Primary Outcome Measures  ICMJE
 (submitted: July 16, 2015)
  • Past 90-day substance use [ Time Frame: Assessed at 6 months after randomization to treatment ]
    Number of days during which substances were used in the past 90 days
  • Evidence of illicit substances in urine screen [ Time Frame: Assessed at 6 months after randomization to treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2015)
  • Parent-adolescent conflict [ Time Frame: Assessed at 6 months after randomization to treatment ]
    Parent and youth report of conflict on the Conflict Behavior Questionnaire
  • Disruptive Behaviors [ Time Frame: 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 and the Disruptive Behavior Questionnaire.
  • Likelihood of future substance use [ Time Frame: Assessed at 6 months after randomization to treatment ]
    Youth self-report of likelihood of future substance use during the next 3 months and the next year
  • Youth impairment [ Time Frame: 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 parent report and adolescent self-report on the Impairment Rating Scale.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intervention for Teens With ADHD and Substance Use
Official Title  ICMJE Intervention for Teens With ADHD and Substance Use
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Attention Deficit Hyperactivity Disorder
Intervention  ICMJE
  • 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.
    Other Name: BEI, Teen Intervene
  • Behavioral: 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.
    Other Name: Concerta
Study Arms  ICMJE
  • Active Comparator: Continued Monitoring and Assessment
    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.
    Intervention: Behavioral: Brief Early Intervention
  • Active Comparator: PT with ACBT
    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).
    Interventions:
    • Behavioral: Brief Early Intervention
    • Behavioral: Parent Training with Adolescent Cognitive Behavioral Therapy
  • Active Comparator: PT with ACBT and 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.
    Interventions:
    • Behavioral: Brief Early Intervention
    • Behavioral: Parent Training with Adolescent Cognitive Behavioral Therapy
    • Drug: Methylphenidate
Publications * Winters KC, Leitten W. Brief intervention for drug-abusing adolescents in a school setting. Psychol Addict Behav. 2007 Jun;21(2):249-54.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 16, 2015)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: William E Pelham, PHD 3053480477 wpelham@fiu.edu
Contact: Nicole K Schatz, PHD 3053480477 nschatz@fiu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02502799
Other Study ID Numbers  ICMJE DA034731
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Florida International University
Study Sponsor  ICMJE Florida International University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William E Pelham, PHD Florida International University
PRS Account Florida International University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP