Treatment for Teens With Alcohol Abuse and Depression

Alcohol and other substance use disorders (AOSUDs), primarily cannabis use disorders,
continue to be a significant public health concern among American adolescents. AOSUDs are
commonly accompanied by co-occurring psychiatric disorders including depression. This
comorbidity has been associated with increased severity of AOSUD, earlier treatment
termination, poorer outcomes, and increased suicidal risk. Presently there is neither a
consensus nor a standard, evidence-based intervention to address the need for an effective
and feasible treatment for both disorders. However, cognitive behavior therapy (CBT) has been
found to be effective for each of these disorders, separately. In addition, in some, but not
all, adolescents with both disorders, depression appears to respond rapidly to CBT that
targets only alcohol or substance abuse. This suggests that early depression responders
(EDRs) may not need additional treatment that targets depression directly, unlike their
non-early responding (NEDR) counterparts. However, no studies have compared longer term
outcomes of adolescent EDRs to NEDRs. Moreover, no randomized, controlled studies have tested
the hypothesis that an integrated CBT intervention for co-occurring AOSUD and depression will
be effective for both disorders, in NEDR adolescents.

In this two-site study, submitted in response to PA: PAS-10-251, we will recruit 170 eligible
adolescents (102 at the University of Connecticut and 68 at Duke University), ages 13 years
to 21 years-11 months, with alcohol or cannabis use disorders and clinically significant
depression. All subjects will receive 12 sessions of Motivation Enhancement Therapy/Cognitive
Behavior Therapy (MET/CBT-12), a standard, evidence-based intervention for alcohol or drug
abuse over 12 to 14 weeks. After four weeks, NEDR adolescents will be randomized to
depression treatment augmentation, either with seven sessions of CBT (CBT-D), integrated with
MET/CBT-12, or with enhanced depression-treatment-as-usual in the community (D-ETAU). We
estimate that 120 adolescents will be randomized; we will stratify randomization on gender,
age, and presence/absence of a Major Depressive Episode. We will assess all 170 participants
at baseline, weeks 4, 9, and 14 (after treatment), and at 3-, 6-, and 9-month follow-up.

The first aim of this study is to describe the percentage of depressed AOSUD adolescents who
demonstrate EDR during alcohol or cannabis abuse treatment alone, examine EDR durability and
EDR predictors. The second and third aims test the hypotheses that, for NEDR teens, an
integrated treatment augmentation (CBT-D) will lead to better depression and alcohol or
cannabis outcomes, respectively, than augmentation with D-ETAU. We will compare outcomes of
all three groups (EDRs; and NEDRs in each augmentation), on alcohol use, depressive symptoms,
alcohol- or cannabis-related functional impairment, maintenance of alcohol or cannabis
treatment gains, and depression remission rates over time, and will analyze the temporal
ordering of changes in alcohol or cannabis use and depression during and after treatment.
This is the first study to test an adaptive treatment model with depressed alcohol or
cannabis use disorder youths, and thus has significant potential to guide clinical practice.

Inclusion Criteria:

- Age 13 years to 21 years, 11 months at baseline

- Current alcohol or cannabis abuse or dependence diagnosis (DSM-IV) OR current level of
potentially harmful drinking or cannabis use as evidenced by (1) consumption of 4 or
more drinks per drinking day (males) or three or more (females), or use of cannabis at
least three times in past 90 days (or before admission into a controlled environment)

- Current clinically significant depression, defined as a score of 40 or more on the
Children's Depression Rating Scale-Revised at baseline

- If currently taking anti-depressant medication, on a stable dose for at least one
month

- Willingness to accept treatment

- Able to speak and read English (5th-grade level)

- Residence within 45-minute drive from treatment site

- Adolescent and a parent agree to sign Institutional Review Board approved
consent/assent form; for subjects ages 18-19, parent involvement is optional and is
the decision of the youth

- Parent/guardian agrees to provide collateral information and to designate two third
parties who could be contacted in case the subject is lost to follow-up; for subjects
ages 18-19, the participating youth will provide this information

- Participant (and parent, if youth is under age 18) not planning to move outside the
area in the next 9 months.

Exclusion Criteria:

- Suicidal ideation with a plan, or suicide attempt within 30 days. In addition to such
suicide risk being indicated in baseline interview material, a score exceeding the
89th percentile on the Suicide Ideation Questionnaire (SIQ-Jr), will necessitate an
immediate risk assessment by the Independent Evaluator which may lead to exclusion
under this criterion.

- Homicidal ideation with a plan or any plan to hurt others

- Lifetime diagnosis of psychosis, schizophrenia, bipolar disorder, intellectual
disability or autistic disorder

- Current dependence on a substance other than alcohol, marijuana or nicotine

- Current non-alcohol or cannabis use disorder or depression primary diagnosis, i.e.,
the diagnosis requires care more urgently than does alcohol or cannabis use disorder
or depression