Attention Deficit Hyperactivity DisorderPhase 3NCT02502799

Intervention for Teens With ADHD and Substance Use

A Phase 3 study testing Brief Early Intervention, Parent Training with Adolescent Cognitive Behavioral Therapy and Methylphenidate in people with Attention Deficit Hyperactivity Disorder, run by Florida International University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 12 to 16 years
Conditions the study is for: Attention Deficit Hyperactivity Disorder
What is being tested?: Brief Early Intervention, Parent Training with Adolescent Cognitive Behavioral Therapy and Methylphenidate
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 158 participants
Where: 1 siteUnited States
Study dates: Jul 2015to Aug 2021
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Florida International University Center for Children and Families
Miami, Florida, 33199

Other trials in United States

About this study

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.

Read the 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.

Conditions: Attention Deficit Hyperactivity Disorder
Being tested: Brief Early Intervention, Parent Training with Adolescent Cognitive Behavioral Therapy, Methylphenidate
Medical subject headings: Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Brief Early InterventionBehavioural
Also called BEI, Teen Intervene
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 TherapyBehavioural
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.
MethylphenidateDrug
Also called Concerta
Adolescents will receive methylphenidate.

Study groups in NCT02502799
Study group	Role	What they receive
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. Receives: 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). Receives: 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. Receives: Behavioral: Brief Early Intervention; Behavioral: Parent Training with Adolescent Cognitive Behavioral Therapy; Drug: Methylphenidate

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Past 90-day Alcohol Use
Teen self-report of substance use during the past 90 days
Measured: 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)
Measured: Assessed at 6 months after randomization to treatment

Secondary outcomes (4)

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).
Measured: Assessed at 6 months after randomization to treatment
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.
Measured: 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).
Measured: 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.
Measured: Assessed at 6 months after randomization to treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2015Aug 2021

First posted20 Jul 2015 (estimated)
Study startJul 2015
Primary completionAug 2021
Study completionAug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 158 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02502799
Sponsor's protocol ID: DA034731
Status last verified: Dec 2022
First submitted: 15 Jul 2015
Last updated: 22 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 17563146

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Attention Deficit Hyperactivity Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intervention for Teens With ADHD and Substance Use
ClinicalTrials.gov ID: NCT02502799
Acronym / sponsor ID: DA034731
Conditions: Attention Deficit Hyperactivity Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 158 participants (actual)
Lead sponsor: Florida International UniversityUniversity, hospital or other
Study start: Jul 2015
Primary completion: Aug 2021 (actual)
Study completion: Aug 2021 (actual)
First posted: 20 Jul 2015 (estimated)
Results: Posted 22 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Continued Monitoring and Assessment	Active comparator	Behavioral: Brief Early InterventionAll 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.
PT with ACBT	Active comparator	Behavioral: Brief Early Intervention, Behavioral: Parent Training with Adolescent Cognitive Behavioral TherapyAll 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	Behavioral: Brief Early Intervention, Behavioral: Parent Training with Adolescent Cognitive Behavioral Therapy, Drug: MethylphenidateAll 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.

Who may qualify

Ages: 12 to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

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).

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Brief Early InterventionAlso: BEI, Teen InterveneAdolescents 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.	Behavioural	Continued Monitoring and Assessment, PT with ACBT, PT with ACBT and Methylphenidate
Parent Training with Adolescent Cognitive Behavioral TherapyParticipants 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.	Behavioural	PT with ACBT, PT with ACBT and Methylphenidate
MethylphenidateAlso: ConcertaAdolescents will receive methylphenidate.	Drug	PT with ACBT and Methylphenidate

Primary outcome

Number of Participants With Past 90-day Alcohol Use
Time frame: Assessed at 6 months after randomization to treatment
Teen self-report of substance use during the past 90 days
Number of Participants With 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)

4 secondary outcomes

Mean Youth-Report of Parent-adolescent Conflict
Time frame: Assessed at 6 months after randomization to treatment
Mean Youth Self-Report of Disruptive Behaviors
Time frame: Assessed at 6 months after randomization to treatment
Mean Youth Self-Report of Likelihood of Future Substance Use
Time frame: Assessed at 6 months after randomization to treatment
Mean Youth Self-Report of Functional Impairment
Time frame: Assessed at 6 months after randomization to treatment

Results and safety

Results posted to the registry on 22 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Continued Monitoring and Assessment	0	0
PT With ACBT	0	0
PT With ACBT and Methylphenidate	0	0
All Participants	158	141

Primary outcome: Number of Participants With Past 90-day Alcohol Use

Time frame: Assessed at 6 months after randomization to treatment. Count of participants. Unit: Participants

Measure	Continued Monitoring and Assessment n = 16	PT With ACBT n = 17	PT With ACBT and Methylphenidate n = 16
Missing data on this measure	6	13	8
No alcohol use	3	1	1
Used alcohol 1-2 times	2	3	3
Used alcohol 3-5 times	3	0	2
Used alcohol 6-9 times	2	0	1
Used alcohol 10-19 times	0	0	0
Used alcohol 20-39 times	0	0	1
Used alcohol 40 times or more	0	0	0

Primary outcome: Number of Participants With Evidence of Illicit Substances in Urine Screen

Time frame: Assessed at 6 months after randomization to treatment. Count of participants. Unit: Participants

Measure	Continued Monitoring and Assessment n = 16	PT With ACBT n = 17	PT With ACBT and Methylphenidate n = 16
Missing data on this measure	8	13	8
Positive for at least one substance	3	4	5
Negative for all substances	5	0	3

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected over the duration of participation in the study, which could be up to 24 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Continued Monitoring and Assessment	0 of 16 (0%)	0 of 16 (0%)	0 of 16
PT With ACBT	1 of 17 (5.9%)	0 of 17 (0%)	0 of 17
PT With ACBT and Methylphenidate	1 of 16 (6.3%)	0 of 16 (0%)	0 of 16
All Participants	0 of 158 (0%)	0 of 158 (0%)	0 of 158

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17563146Winters 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William E Pelham, PHD principal investigator

Florida International University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Past 90-day Alcohol Use (time frame: Assessed at 6 months after randomization to treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02502799, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023; AzTrials last refreshed its copy on 29 Oct 2026.