Attention Deficit Hyperactivity Disorder Clinical Trial
Official title:
Intervention for Teens With ADHD and Substance Use
NCT number | NCT02502799 |
Other study ID # | DA034731 |
Secondary ID | |
Status | Terminated |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | July 2015 |
Est. completion date | August 2021 |
Verified date | December 2022 |
Source | Florida International University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Florida International University Center for Children and Families | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Florida International University |
United States,
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
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 |
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