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Intervention for Teens With ADHD and Substance Use

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Brief Early Intervention
Parent Training with Adolescent Cognitive Behavioral Therapy
Methylphenidate
Sponsored by
Florida International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

12 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Florida International University Center for Children and Families

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Continued Monitoring and Assessment

PT with ACBT

PT with ACBT and Methylphenidate

Arm Description

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.

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).

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.

Outcomes

Primary Outcome Measures

Number of Participants With Past 90-day Alcohol Use
Teen self-report of substance use during the past 90 days
Number of Participants With Evidence of Illicit Substances in Urine Screen
Urine analysis indicates presence of illicit substance(s)

Secondary Outcome Measures

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).
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.
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).
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.

Full Information

First Posted
July 15, 2015
Last Updated
February 23, 2023
Sponsor
Florida International University
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1. Study Identification

Unique Protocol Identification Number
NCT02502799
Brief Title
Intervention for Teens With ADHD and Substance Use
Official Title
Intervention for Teens With ADHD and Substance Use
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Study Start Date
July 2015 (undefined)
Primary Completion Date
August 2021 (Actual)
Study Completion Date
August 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Florida International University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continued Monitoring and Assessment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
PT with ACBT
Arm Type
Active Comparator
Arm Description
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).
Arm Title
PT with ACBT and Methylphenidate
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief Early Intervention
Other Intervention Name(s)
BEI, Teen Intervene
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Parent Training with Adolescent Cognitive Behavioral Therapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Other Intervention Name(s)
Concerta
Intervention Description
Adolescents will receive methylphenidate.
Primary Outcome Measure Information:
Title
Number of Participants With Past 90-day Alcohol Use
Description
Teen self-report of substance use during the past 90 days
Time Frame
Assessed at 6 months after randomization to treatment
Title
Number of Participants With Evidence of Illicit Substances in Urine Screen
Description
Urine analysis indicates presence of illicit substance(s)
Time Frame
Assessed at 6 months after randomization to treatment
Secondary Outcome Measure Information:
Title
Mean Youth-Report of Parent-adolescent Conflict
Description
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).
Time Frame
Assessed at 6 months after randomization to treatment
Title
Mean Youth Self-Report of Disruptive Behaviors
Description
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.
Time Frame
Assessed at 6 months after randomization to treatment
Title
Mean Youth Self-Report of Likelihood of Future Substance Use
Description
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).
Time Frame
Assessed at 6 months after randomization to treatment
Title
Mean Youth Self-Report of Functional Impairment
Description
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.
Time Frame
Assessed at 6 months after randomization to treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William E Pelham, PHD
Organizational Affiliation
Florida International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida International University Center for Children and Families
City
Miami
State/Province
Florida
ZIP/Postal Code
33199
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17563146
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.
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Intervention for Teens With ADHD and Substance Use

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