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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Mean Youth Self-Report of Disruptive Behaviors |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William E Pelham, PHD | Florida International University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida International University Center for Children and Families | Miami | Florida | 33199 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17563146 | Background | 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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All participants received an initial 5-session substance use prevention program. Participants then completed follow-up assessments to determine level of substance use. Participants identified as having non-normative substance use at any follow-up were moved into the second phase of the study and randomly assigned to one of the three treatment groups. Participants who were never identified as having non-normative substance use were considered responders and were not randomized to a treatment arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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). 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. 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. |
| FG002 | 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. 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. 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. Methylphenidate: Adolescents will receive methylphenidate. |
| FG003 | All Participants | All participants for this study were initially assigned to receive the brief 5-session intervention. Six months following completion of that intervention, follow-up assessments took place to assess response to treatment. At that time, participants identified as "Non-responders" to the brief 5-session intervention were randomly assigned to one of three conditions. Participants (n=109) who were identified as "Responders" were never randomized and received no further intervention. The "Responders" also do not have data for phase 2 of this study because they were never randomized to a treatment arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: Brief Intervention Sessions |
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| ||||||||||||||||||
| Phase 2: Intervention Phase |
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| ID | Title | Description |
|---|---|---|
| BG000 | Responders (Never Randomized) | These participants received the 5 sessions of BEI; however, were never identified as non-responders to the initial intervention and were never randomized to one of the three treatment groups. |
| BG001 | Continued Monitoring and Assessment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Past 90-day Alcohol Use | Teen self-report of substance use during the past 90 days | Posted | Count of Participants | Participants | Assessed at 6 months after randomization to treatment |
|
Adverse event data were collected over the duration of participation in the study, which could be up to 24 months.
Participants were interviewed about potential adverse events at each follow-up assessment point. Additionally, participants were instructed to notify the investigators in the event of an adverse event between assessment points. Participants identified as "Responders (Never Randomized)" were never randomized to a treatment arm and are therefore not included in adverse event reporting.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. Adverse events for this group represent those report during Phase 2: Intervention Phase. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Admitted to in-patient psychiatric unit | Psychiatric disorders | Systematic Assessment | Participant admitted to in-patient psychiatric unit; however, hospitalization was not related to participation in the study. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. William E. Pelham Jr. | Florida International University | 305-348-3002 | wpelham@fiu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 16, 2019 | Dec 9, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| 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. |
|
| Methylphenidate | Drug | Adolescents will receive methylphenidate. |
|
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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 |
| 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 |
| 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 |
| Early termination of study |
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| COMPLETED |
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| NOT COMPLETED |
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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. 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. |
| BG002 | 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). 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. 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. |
| BG003 | 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. 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. 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. Methylphenidate: Adolescents will receive methylphenidate. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Past 90-day alcohol use | Teen self-report of alcohol use during the past 90 days. | Count of Participants | Participants |
|
| Past 90-day marijuana use | Teen self-report of frequency of marijuana use in the past 90 days | Count of Participants | Participants |
|
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). 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. 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. |
| OG002 | 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. 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. 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. Methylphenidate: Adolescents will receive methylphenidate. |
|
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| Primary | Number of Participants With Evidence of Illicit Substances in Urine Screen | Urine analysis indicates presence of illicit substance(s) | Posted | Count of Participants | Participants | Assessed at 6 months after randomization to treatment |
|
|
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| 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). | Analysis population includes all participants with complete data on this measure at this time point. | Posted | Mean | Standard Deviation | score on a scale | Assessed at 6 months after randomization to treatment |
|
|
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| 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. | Analysis population includes all participants with complete data on this measure. | Posted | Mean | Standard Deviation | score on a scale | Assessed at 6 months after randomization to treatment |
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| 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). | Analysis population includes all participants with complete data on this measure. | Posted | Mean | Standard Deviation | score on a scale | 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. | Analysis population includes all participants with complete data on this measure. | Posted | Mean | Standard Deviation | score on a scale | Assessed at 6 months after randomization to treatment |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | 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). 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. 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. Adverse events for this group represent those report during Phase 2: Intervention Phase. | 0 | 17 | 1 | 17 | 0 | 17 |
| EG002 | 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. 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. 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. Methylphenidate: Adolescents will receive methylphenidate. Adverse events for this group represent those report during Phase 2: Intervention Phase. | 0 | 16 | 1 | 16 | 0 | 16 |
| EG003 | All Participants | All participants for this study were initially assigned to receive the brief 5-session intervention. Six months following completion of that intervention, follow-up assessments took place to assess response to treatment. Adverse events reported below reflect those reported for participants during Phase 1: Brief Intervention. | 0 | 158 | 0 | 158 | 0 | 158 |
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| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Negative for all substances |
|