Intervention for Teens With ADHD and Substance Use

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02502799

Enrollment

158

Registered

2015-07-20

Start date

2015-07-31

Completion date

2021-08-31

Last updated

2023-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder

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.

Interventions

BEHAVIORALBrief 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.

BEHAVIORALParent 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.

DRUGMethylphenidate

Adolescents will receive methylphenidate.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 16 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Past 90-day Alcohol Use	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	Assessed at 6 months after randomization to treatment	Urine analysis indicates presence of illicit substance(s)

Secondary

Measure	Time frame	Description
Mean Youth-Report of Parent-adolescent Conflict	Assessed at 6 months after randomization to treatment	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	Assessed at 6 months after randomization to treatment	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	Assessed at 6 months after randomization to treatment	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	Assessed at 6 months after randomization to treatment	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.

Countries

United States

Participant flow

Pre-assignment details

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.

Participants by arm

Arm	Count
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.	109
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.	16
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.	17
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.	16
Total	158

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Phase 1: Brief Intervention Sessions	Early termination of study	0	0	0	5
Phase 1: Brief Intervention Sessions	Lost to Follow-up	0	0	0	12
Phase 2: Intervention Phase	Lost to Follow-up	3	4	1	0
Phase 2: Intervention Phase	Study terminated prior to completion	4	5	5	0
Phase 2: Intervention Phase	Withdrawal by Subject	3	2	3	0

Baseline characteristics

Characteristic	Responders (Never Randomized)	Continued Monitoring and Assessment	PT With ACBT	PT With ACBT and Methylphenidate	Total
Age, Continuous	13.77 years STANDARD_DEVIATION 1.38	14.63 years STANDARD_DEVIATION 1.31	14.12 years STANDARD_DEVIATION 1.17	14.25 years STANDARD_DEVIATION 1.44	13.94 years STANDARD_DEVIATION 1.38
Past 90-day alcohol use 10-19 Times	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants
Past 90-day alcohol use 1-2 Times	18 Participants	3 Participants	7 Participants	7 Participants	35 Participants
Past 90-day alcohol use 20-39 Times	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Past 90-day alcohol use 3-5 Times	3 Participants	2 Participants	1 Participants	0 Participants	6 Participants
Past 90-day alcohol use 40 Times or More	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Past 90-day alcohol use 6-9 Times	5 Participants	3 Participants	0 Participants	1 Participants	9 Participants
Past 90-day alcohol use No use	82 Participants	7 Participants	9 Participants	7 Participants	105 Participants
Past 90-day marijuana use 10-19 Times	2 Participants	1 Participants	1 Participants	1 Participants	5 Participants
Past 90-day marijuana use 1-2 Times	1 Participants	2 Participants	2 Participants	3 Participants	8 Participants
Past 90-day marijuana use 20-39 Times	1 Participants	1 Participants	0 Participants	1 Participants	3 Participants
Past 90-day marijuana use 3-5 Times	4 Participants	2 Participants	2 Participants	0 Participants	8 Participants
Past 90-day marijuana use 40 Times or More	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Past 90-day marijuana use 6-9 Times	0 Participants	3 Participants	0 Participants	0 Participants	3 Participants
Past 90-day marijuana use No Use	101 Participants	6 Participants	12 Participants	11 Participants	130 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Black or African American	8 Participants	2 Participants	3 Participants	1 Participants	14 Participants
Race (NIH/OMB) More than one race	14 Participants	0 Participants	1 Participants	0 Participants	15 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants	1 Participants	0 Participants	0 Participants	4 Participants
Race (NIH/OMB) White	84 Participants	13 Participants	13 Participants	14 Participants	124 Participants
Region of Enrollment United States	109 participants	16 participants	17 participants	16 participants	158 participants
Sex: Female, Male Female	27 Participants	3 Participants	6 Participants	5 Participants	41 Participants
Sex: Female, Male Male	82 Participants	13 Participants	11 Participants	11 Participants	117 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 16	0 / 17	0 / 16	0 / 158
other Total, other adverse events	0 / 16	0 / 17	0 / 16	0 / 158
serious Total, serious adverse events	0 / 16	1 / 17	1 / 16	0 / 158