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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

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.


Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Behavioral: Brief Early Intervention Behavioral: Parent Training with Adolescent Cognitive Behavioral Therapy Drug: Methylphenidate Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intervention for Teens With ADHD and Substance Use
Study Start Date : July 2015
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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).
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.

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.
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




Primary Outcome Measures :
  1. 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

  2. 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)


Secondary Outcome Measures :
  1. Parent-adolescent conflict [ Time Frame: Assessed at 6 months after randomization to treatment ]
    Parent and youth report of conflict on the Conflict Behavior Questionnaire

  2. 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.

  3. 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

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502799


Contacts
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Contact: William E Pelham, PHD 3053480477 wpelham@fiu.edu
Contact: Nicole K Schatz, PHD 3053480477 nschatz@fiu.edu

Locations
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United States, Florida
Florida International University Center for Children and Families Recruiting
Miami, Florida, United States, 33199
Principal Investigator: William E Pelham, Ph.D.         
Sponsors and Collaborators
Florida International University
Investigators
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Principal Investigator: William E Pelham, PHD Florida International University
Publications:
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Responsible Party: Florida International University
ClinicalTrials.gov Identifier: NCT02502799    
Other Study ID Numbers: DA034731
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents