Intervention for Teens With ADHD and Substance Use

NCT02502799 | Terminated Phase 3 Results

• 1 other identifier: DA034731
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Mean Youth-Report of Parent-adolescent Conflict

  Assessed at 6 months after randomization to treatment

• Mean Youth Self-Report of Disruptive Behaviors

  Assessed at 6 months after randomization to treatment

• Mean Youth Self-Report of Likelihood of Future Substance Use

  Assessed at 6 months after randomization to treatment

• Mean Youth Self-Report of Functional Impairment

  Assessed at 6 months after randomization to treatment

Study Arms (3)

Continued Monitoring and Assessment

ACTIVE COMPARATOR

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

PT with ACBT

ACTIVE COMPARATOR

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; Behavioral: Parent Training with Adolescent Cognitive Behavioral Therapy

PT with ACBT and Methylphenidate

ACTIVE COMPARATOR

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; Behavioral: Parent Training with Adolescent Cognitive Behavioral Therapy; Drug: Methylphenidate

Interventions

Brief Early Intervention BEHAVIORAL

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.

Also known as: BEI, Teen Intervene

Continued Monitoring and Assessment; PT with ACBT; PT with ACBT and Methylphenidate

Parent Training with Adolescent Cognitive Behavioral Therapy BEHAVIORAL

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.

PT with ACBT; PT with ACBT and Methylphenidate

Methylphenidate DRUG

Adolescents will receive methylphenidate.

Also known as: Concerta

PT with ACBT and Methylphenidate

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida International University: lead

Study Sites (1)

Florida International University Center for Children and Families

Miami, Florida, 33199, United States

Location

Related 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.

  PMID: 17563146 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Enrollment in this study fell well short of the planned 300 participants, despite substantial efforts to increase enrollment over the life of the project, and the study was terminated prior to reaching the planned enrollment target. As a result, the number of participants randomized to treatment condition was insufficient to conduct planned analyses. Furthermore, of those participants randomized, many refused assigned treatments.

Results Point of Contact

• Title: Dr. William E. Pelham Jr.
• Organization: Florida International University

wpelham@fiu.edu

305-348-3002

Study Officials

• William E Pelham, PHD

  Florida International University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: July 20, 2015
• Study Start: July 1, 2015
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: March 22, 2023
• Results First Posted: March 22, 2023

Record last verified: 2022-12

Locations

US (1)