AOD Use, Abuse, and DependenceT-TAADNCT02227589
Treatment for Teens With Alcohol Abuse and Depression
A study testing MET/CBT-12, CBT-D and D-TAU in people with AOD Use, Abuse, and Dependence and Depression, run by Duke University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years to 263 months
- Conditions the study is for
- AOD Use, Abuse, and Dependence, Depression
- What is being tested?
- MET/CBT-12, CBT-D and D-TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Jan 2015to 3 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 years to 263 months
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke Child and Family Study Center
Durham, North Carolina, 27705
University of Connecticut Health Center
Farmington, Connecticut, 06030-3926
About this study
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.
Read the detailed description
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.
- Conditions
- AOD Use, Abuse, and Dependence, Depression
- Being tested
- MET/CBT-12, CBT-D, D-TAU
- Keywords
- adolescent,, alcohol abuse, depression,, cognitive behavior therapy, cannabis abuse
- Medical subject headings
- Depression, Alcoholism, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MET/CBT-12Behavioural
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.
CBT-DBehavioural
CBT-D consists of seven weekly sessions of cognitive behavior therapy targeting depression.
D-TAUOther
D-TAU is treatment as usual in the community, targeting depression. It may consist of medication and/or behavioral intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: MET/CBT-12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to week 14; Change from baseline to 9 months after treatment ends
Secondary outcomes (5)
Diagnosis
At baseline, week 14 (end of treatment), and 9 months after treatment, the adolescent will complete the Voice DISC diagnostic interview to determine whether he or she continues to meet criteria for an alcohol or cannabis use disorder
Measured: Baseline to Week 14; baseline to 9 Months after treatment ends
Teen-Addiction Severity Index (T-ASI)
The Independent Evaluator will complete the T-ASI with the adolescent and parent at every assessment point (baseline, week 4, week 9, week 14, and then 3, 6, and 9 months after treatment ends) to determine whether there are changes in substance-use-related functional problems
Measured: Baseline to Week 14; baseline to 9 months after treatment ends
Suicidal Ideation Questionnaire-Jr. High Version (SIQ-Jr)
Adolescents will complete this self-report form at every assessment point (baseline, week 4, week, 9, week 14; and then 3, 6, and 9 months after treatment ends) to determine if there are significant reductions in suicidal ideation
Measured: Baseline to Week 14; baseline to 9 months after treatment ends
Children's Global Assessment of Functioning (CGAS)
The Independent Evaluator will make this single item rating of global functioning at every assessment point (baseline, week 4, week 9, week 14, and then 3, 6, and 9 months after treatment ends) to determine if there are significant improvements in adolescent's overall functioning
Measured: Baseline to Week 14; baseline to 9 months after treatment ends
Clinical Global Impression-Improvement in Depression (CGI-I)
At every assessment point except baseline (at week 4, week 9, week 14, and then at 3, 6, and 9 months after treatment ends), the independent evaluator will rate the adolescent's improvement since baseline in the domain of depression, using CDRS-R scores as the reference. The CGI-I score determines whether the adolescent is a partial or full responder, or a non-responder to treatment.
Measured: Baseline to Week 14; baseline to 9 months after treatment ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study start16 Jan 2015
- Primary completion3 Jan 2020
- Study completion3 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AOD Use, Abuse, and DependenceStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- UConn Health, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- John F Curry, PhD, Principal investigator, Duke UniversityYifrah Kaminer, M.D., Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227589
- Sponsor's protocol ID
- Pro00053448
- Other IDs
- 1R01AA021719-01A1, 1R01AA021735-01A1
- Acronym
- T-TAAD
- Status last verified
- Feb 2019
- First submitted
- 26 Aug 2014
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34371102
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for Teens With Alcohol Abuse and Depression
- ClinicalTrials.gov ID
- NCT02227589
- Acronym / sponsor ID
- T-TAAD / Pro00053448
- Conditions
- AOD Use, Abuse, and Dependence, Depression
- Keywords
- adolescent,, alcohol abuse, depression,, cognitive behavior therapy, cannabis abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- UConn Health, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 16 Jan 2015 (actual)
- Primary completion
- 3 Jan 2020 (actual)
- Study completion
- 3 Jan 2020 (actual)
- First posted
- 28 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MET/CBT-12 plus CBT-D | Experimental | Behavioral: MET/CBT-12, Behavioral: CBT-DCBT-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. |
| MET/CBT-12 plus D-TAU | Active comparator | Behavioral: MET/CBT-12, Other: D-TAUD-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. |
| MET/CBT-12 alone | Active comparator | Behavioral: MET/CBT-12MET/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. |
Who may qualify
- Ages
- 13 years to 263 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| MET/CBT-12Two 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. | Behavioural | MET/CBT-12 alone, MET/CBT-12 plus CBT-D, MET/CBT-12 plus D-TAU |
| CBT-DCBT-D consists of seven weekly sessions of cognitive behavior therapy targeting depression. | Behavioural | MET/CBT-12 plus CBT-D |
| D-TAUD-TAU is treatment as usual in the community, targeting depression. It may consist of medication and/or behavioral intervention. | Other | MET/CBT-12 plus D-TAU |
Primary outcome
Alcohol use frequency assessed with the Alcohol Consumption Questionnaire
Time frame: Change from baseline to week 14; change from baseline to 9 months after treatment ends
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).
Severity of depression, as measured on the Children's Depression Rating Scale-Revised (CDRS-R)
Time frame: Change from baseline to week 4; Change from baseline to week 14; Change from baseline to 9 months after treatment ends
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.
Alcohol use quantity assessed with the Alcohol Consumption Questionnaire
Time frame: Change from baseline to week 14; Change from baseline to 9 months after treatment ends
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.
Cannabis use frequency assessed with the Drug Checklist
Time frame: Change from baseline to week 14; Change from baseline to 9 months after treatment ends
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.
5 secondary outcomes
Diagnosis
Time frame: Baseline to Week 14; baseline to 9 Months after treatment ends
Teen-Addiction Severity Index (T-ASI)
Time frame: Baseline to Week 14; baseline to 9 months after treatment ends
Suicidal Ideation Questionnaire-Jr. High Version (SIQ-Jr)
Time frame: Baseline to Week 14; baseline to 9 months after treatment ends
Children's Global Assessment of Functioning (CGAS)
Time frame: Baseline to Week 14; baseline to 9 months after treatment ends
Clinical Global Impression-Improvement in Depression (CGI-I)
Time frame: Baseline to Week 14; baseline to 9 months after treatment ends
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Derived from this study: PubMed 34371102Curry 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.
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.
John F Curry, PhD principal investigator
Duke University
Yifrah Kaminer, M.D. principal investigator
UConn Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MET/CBT-12, CBT-D and D-TAU in people with AOD Use, Abuse, and Dependence and Depression, run by Duke University at 2 sites in United States.
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 10 inclusion and 5 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: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Alcohol use frequency assessed with the Alcohol Consumption Questionnaire (time frame: Change from baseline to week 14; change from baseline to 9 months after treatment ends). The study lists 4 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 NCT02227589, 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 5 Feb 2020.