Treatment for Teens With Alcohol Abuse and Depression

NCT02227589 | Completed DMC

• 3 other identifiers: Pro000534481R01AA021719-01A11R01AA021735-01A1
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators will recruit adolescents with alcohol or cannabis abuse and clinically significant depression. All participants will receive 12 sessions of an evidence-based treatment for alcohol abuse, Motivation Enhancement Therapy/Cognitive Behavior Therapy-12, over 12 to 14 weeks. Those who are still depressed after 4 weeks will be randomized to receive treatment augmentation with either an integrated cognitive behavior therapy for depression, delivered by their study therapist, or depression treatment-as-usual in the community. The study hypothesis is that integrated depression treatment will surpass community treatment-as-usual in efficacy.

Conditions

AOD Use, Abuse, and Dependence; Depression

Keywords

adolescent,; alcohol abuse; depression,; cognitive behavior therapy; cannabis abuse

Outcome Measures

Primary Outcomes (4)

• Alcohol use frequency assessed with the Alcohol Consumption Questionnaire

  At every assessment point (baseline, weeks 4, 9, and 14 \[end of treatment\]; and then 3, 6, and 9 months after treatment ends, adolescents will be interviewed by an independent evaluator using the Alcohol Consumption Questionnaire regarding alcohol use frequency over the past three months (baseline, and months 3, 6, and 9) or past month (weeks 4, 9, and 14).

  Change from baseline to week 14; change from baseline to 9 months after treatment ends

• Severity of depression, as measured on the Children's Depression Rating Scale-Revised (CDRS-R)

  At every assessment point (baseline, weeks 4, 9, and 14 \[end of treatment\] and then 3, 6, and 9 months after treatment ends, adolescents and parents will be interviewed by an independent evaluator using the CDRS-R, with reference to the adolescent's depression symptoms during the past week. The week 4 assessment determines whether the adolescent is an early responder on depression, defined as having a 50% reduction in CDRS-R score. One item assesses suicidal thinking or behavior.

  Change from baseline to week 4; Change from baseline to week 14; Change from baseline to 9 months after treatment ends

• Alcohol use quantity assessed with the Alcohol Consumption Questionnaire

  At every assessment point (baseline, weeks 4, 9, and 14 \[end of treatment\]; and then 3, 6, and 9 months after treatment ends, adolescents will be interviewed by an independent evaluator regarding alcohol use quantity over the past three months (baseline; months 3, 6, and 9) or past month (weeks 4, 9, and 14), using the Alcohol Consumption Questionnaire.

  Change from baseline to week 14; Change from baseline to 9 months after treatment ends

• Cannabis use frequency assessed with the Drug Checklist

  At every assessment point (baseline, weeks 4, 9, and 14 \[end of treatment\]; and then 3, 6, and 9 months after treatment ends, adolescents will be interviewed by an independent evaluator regarding cannabis use frequency over the past three months (baseline; months 3, 6, and 9) or past month (weeks 4, 9, and 14), using the Drug Checklist.

  Change from baseline to week 14; Change from baseline to 9 months after treatment ends

Secondary Outcomes (5)

• Diagnosis

  Baseline to Week 14; baseline to 9 Months after treatment ends

• Teen-Addiction Severity Index (T-ASI)

  Baseline to Week 14; baseline to 9 months after treatment ends

• Suicidal Ideation Questionnaire-Jr. High Version (SIQ-Jr)

  Baseline to Week 14; baseline to 9 months after treatment ends

• Children's Global Assessment of Functioning (CGAS)

  Baseline to Week 14; baseline to 9 months after treatment ends

• Clinical Global Impression-Improvement in Depression (CGI-I)

  Baseline to Week 14; baseline to 9 months after treatment ends

Other Outcomes (3)

• Beck Depression Inventory-II (BDI-II)

  Baseline to Week 14; baseline to 9 months after treatment ends

• Situational Confidence Questionnaire (SCQ)

  Baseline to Week 14

• Urine analysis

  From baseline through month 9 of follow-up

Study Arms (3)

MET/CBT-12 plus CBT-D

EXPERIMENTAL

CBT-D is an integrated cognitive behavior therapy targeting depression, delivered by the same study therapist who delivers MET/CBT-12 to the adolescent. All adolescents receiving CBT-D remain in MET/CBT-12 with their study provider.

Behavioral: MET/CBT-12; Behavioral: CBT-D

MET/CBT-12 plus D-TAU

ACTIVE COMPARATOR

D-TAU (Depression Treatment as Usual) consists of referral to a depression treatment provider in the community. In this study D-TAU will be enhanced by assistance from the study team in locating providers and, with consent, an assessment report about the adolescent from the study team to the provider. All adolescents receiving TAU for depression remain in MET/CBT-12 with their study provider.

Behavioral: MET/CBT-12; Other: D-TAU

MET/CBT-12 alone

ACTIVE COMPARATOR

MET/CBT-12 consists of two sessions of motivation enhancement therapy and 10 sessions of cognitive behavior therapy, targeting alcohol or cannabis abuse. All adolescents in the study receive MET/CBT-12 over 12 to 14 weeks.

Behavioral: MET/CBT-12

Interventions

MET/CBT-12 BEHAVIORAL

Two sessions of motivation enhancement therapy followed by 10 sessions of cognitive behavior therapy targeting alcohol or cannabis abuse. These 12 sessions will be delivered over 12 to 14 weeks.

MET/CBT-12 alone; MET/CBT-12 plus CBT-D; MET/CBT-12 plus D-TAU

CBT-D BEHAVIORAL

CBT-D consists of seven weekly sessions of cognitive behavior therapy targeting depression.

MET/CBT-12 plus CBT-D

D-TAU OTHER

D-TAU is treatment as usual in the community, targeting depression. It may consist of medication and/or behavioral intervention.

MET/CBT-12 plus D-TAU

Eligibility Criteria

• Age: 13 Years - 263 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• UConn Health: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (2)

University of Connecticut Health Center

Farmington, Connecticut, 06030-3926, United States

Location

Duke Child and Family Study Center

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• Curry JF, Kaminer Y, Goldston DB, Chan G, Wells KC, Burke RH, Inscoe AB, Meyer AE, Cheek SM. Adaptive Treatment for Youth With Substance Use and Depression: Early Depression Response and Short-term Outcomes. J Am Acad Child Adolesc Psychiatry. 2022 Apr;61(4):508-519. doi: 10.1016/j.jaac.2021.07.807. Epub 2021 Aug 6.

  PMID: 34371102 DERIVED

MeSH Terms

Conditions

Depression; Alcoholism; Marijuana Abuse

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• John F Curry, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Yifrah Kaminer, M.D.

  UConn Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Duke site has masked outcomes assessor; University of Connecticut site does not have masked outcomes assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: August 28, 2014
• Study Start: January 16, 2015
• Primary Completion: January 3, 2020
• Study Completion: January 3, 2020
• Last Updated: February 5, 2020

Record last verified: 2019-02

Locations

US (2)