DepressionPhase 1NCT01667159
Community-Based Integrated Treatment for Adolescents
A Phase 1 study testing Integrated Cognitive Behavioral Therapy in people with Depression and Alcohol Use, run by Brown University at 1 site in United States.
Trial summary
This study will examine the effectiveness of an integrated treatment for adolescents who are depressed and use alcohol in an intensive outpatient setting in the community. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Depression, Alcohol Use
- What is being tested?
- Integrated Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Dec 2017
- Phase
- Phase 1
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- English speaking adolescent and parent
- Current substance use disorder
- Co-occurring psychiatric symptomatology
Who cannot join
- IQ < 80
- Diagnosis of psychotic disorder, pervasive developmental disorder, obsessive-compulsive disorder, bulimia nervosa or anorexia nervosa
- Adolescent use of illicit "hard" substances such as cocaine, heroine, and opiates 13 or more times over the prior 90 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adolescents With Major Depression and AUD: Community-Based Integrated Treatment
This study will examine the effectiveness of an integrated treatment for adolescents who are depressed and use alcohol in an intensive outpatient setting in the community.
Read the detailed description
Studies have consistently shown that alcohol use disorders (AUDs) and mental health disorders are related in adolescence. For example, in a community sample, teens who reported a history of AUD were almost four times as likely to have a history of Major Depressive Disorder (MDD) than teens with no history of AUD. The scientific community has only recently begun to examine how to treat adolescents with both AUD and MDD. Reviews have concluded that depression negatively affects treatment for substance abuse. At the same time, substance use issues are often not assessed or addressed in outpatient psychotherapy. Thus, we believe that protocols are needed to specifically address substance abusing, depressed adolescents. This study is designed to determine if an integrated (CBT-I) protocol designed to treat both substance use and depression in adolescents aged 12 to 18 years with AUD/MDD will produce better treatment outcomes compared to standard care (CBT-SC). Both the integrated CBT-I and CBT-SC conditions will be delivered by licensed mental health workers at a community mental health clinic - Gateway - that uses an Intensive Outpatient Program (IOP) model to treat adolescents with AUD and mental health disorders. Two hundred adolescents (50 per year for 4 years) will be recruited from Gateway's Dual Diagnosis IOP. If an adolescent screens in by reporting both depressed mood and substance abuse, these eligible families will complete a thorough baseline assessment and will then be assigned to either CBT-I or CBT-SC. The baseline battery will be repeated at the end of treatment, and 6 and 12 months after treatment completion to determine how families in the study do over time.
- Conditions
- Depression, Alcohol Use
- Being tested
- Integrated Cognitive Behavioral Therapy, Standard Care
- Keywords
- Depression, Alcohol Use, Outpatient Therapy
- Medical subject headings
- Depression, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Cognitive Behavioral TherapyBehavioural
Also called CBT for adolescents and parents
Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions delivered at least 1-2x each week for 6 months.
Standard CareBehavioural
Also called Intensive Outpatient Therapy, Treatment As Usual (TAU)
Intensive outpatient therapy with teens and their parents using a variety of eclectic treatments that characterize standard care for adolescents.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Cognitive Behavioral Therapy | Experimental | Adolescents and their parent(s) will receive integrated cognitive behavioral therapy. Receives: Behavioral: Integrated Cognitive Behavioral Therapy |
| Standard Care | Active comparator | Adolescents and their parent(s) will receive treatment as usual through a community intensive outpatient program. Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Measured: Measured at 18 months from baseline
Secondary outcomes (1)
Alcohol/Substance Use
Measured: Measured at 18 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Anthony Spirito, Brown University
- Investigators
- Anthony Spirito, Ph.D., Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667159
- Sponsor's protocol ID
- 1R01AA020705-01A1
- Other IDs
- 1R01AA020705-01A1
- Status last verified
- Jan 2018
- First submitted
- 14 Aug 2012
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Spirito A, Nestor B, Massing-Schaffer M, Esposito-Smythers C, Stout R, Frazier E, Gomez J, Graves H, Yen S, Hunt J, Wolff J. Predictors and moderators of marijuana and heavy alcohol use outcomes in adolescents treated for co-occurring substance use and psychiatric disorders in a randomized controlled trial. J Subst Abuse Treat. 2021 Dec;131:108536. doi: 10.1016/j.jsat.2021.108536. Epub 2021 Jun 15.
PubMed 34238628MacPherson HA, Wolff J, Nestor B, Frazier E, Massing-Schaffer M, Graves H, Esposito-Smythers C, Spirito A. Parental Monitoring Predicts Depressive Symptom and Suicidal Ideation Outcomes in Adolescents Being Treated for Co-Occurring Substance Use and Psychiatric Disorders. J Affect Disord. 2021 Apr 1;284:190-198. doi: 10.1016/j.jad.2021.02.021. Epub 2021 Feb 9.
PubMed 33607509
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescents With Major Depression and AUD: Community-Based Integrated Treatment
- ClinicalTrials.gov ID
- NCT01667159
- Acronym / sponsor ID
- 1R01AA020705-01A1
- Conditions
- Depression, Alcohol Use
- Keywords
- Depression, Alcohol Use, Outpatient Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jul 2012 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 17 Aug 2012 (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.
This study will examine the effectiveness of an integrated treatment for adolescents who are depressed and use alcohol in an intensive outpatient setting in the community.
Detailed description
Studies have consistently shown that alcohol use disorders (AUDs) and mental health disorders are related in adolescence. For example, in a community sample, teens who reported a history of AUD were almost four times as likely to have a history of Major Depressive Disorder (MDD) than teens with no history of AUD. The scientific community has only recently begun to examine how to treat adolescents with both AUD and MDD. Reviews have concluded that depression negatively affects treatment for substance abuse. At the same time, substance use issues are often not assessed or addressed in outpatient psychotherapy. Thus, we believe that protocols are needed to specifically address substance abusing, depressed adolescents. This study is designed to determine if an integrated (CBT-I) protocol designed to treat both substance use and depression in adolescents aged 12 to 18 years with AUD/MDD will produce better treatment outcomes compared to standard care (CBT-SC). Both the integrated CBT-I and CBT-SC conditions will be delivered by licensed mental health workers at a community mental health clinic - Gateway - that uses an Intensive Outpatient Program (IOP) model to treat adolescents with AUD and mental health disorders. Two hundred adolescents (50 per year for 4 years) will be recruited from Gateway's Dual Diagnosis IOP. If an adolescent screens in by reporting both depressed mood and substance abuse, these eligible families will complete a thorough baseline assessment and will then be assigned to either CBT-I or CBT-SC. The baseline battery will be repeated at the end of treatment, and 6 and 12 months after treatment completion to determine how families in the study do over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Cognitive Behavioral Therapy | Experimental | Behavioral: Integrated Cognitive Behavioral TherapyAdolescents and their parent(s) will receive integrated cognitive behavioral therapy. |
| Standard Care | Active comparator | Behavioral: Standard CareAdolescents and their parent(s) will receive treatment as usual through a community intensive outpatient program. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- English speaking adolescent and parent
- Current substance use disorder
- Co-occurring psychiatric symptomatology
Key exclusion criteria (3 listed)
- IQ < 80
- Diagnosis of psychotic disorder, pervasive developmental disorder, obsessive-compulsive disorder, bulimia nervosa or anorexia nervosa
- Adolescent use of illicit "hard" substances such as cocaine, heroine, and opiates 13 or more times over the prior 90 days
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 |
|---|---|---|
| Integrated Cognitive Behavioral TherapyAlso: CBT for adolescents and parentsIndividual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions delivered at least 1-2x each week for 6 months. | Behavioural | Integrated Cognitive Behavioral Therapy |
| Standard CareAlso: Intensive Outpatient Therapy, Treatment As Usual (TAU)Intensive outpatient therapy with teens and their parents using a variety of eclectic treatments that characterize standard care for adolescents. | Behavioural | Standard Care |
Primary outcome
Depression
Time frame: Measured at 18 months from baseline
1 secondary outcome
Alcohol/Substance Use
Time frame: Measured at 18 months from baseline
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 23 Jan 2018.
- Derived from this study: PubMed 34238628Spirito A, Nestor B, Massing-Schaffer M, Esposito-Smythers C, Stout R, Frazier E, Gomez J, Graves H, Yen S, Hunt J, Wolff J. Predictors and moderators of marijuana and heavy alcohol use outcomes in adolescents treated for co-occurring substance use and psychiatric disorders in a randomized controlled trial. J Subst Abuse Treat. 2021 Dec;131:108536. doi: 10.1016/j.jsat.2021.108536. Epub 2021 Jun 15.
- Derived from this study: PubMed 33607509MacPherson HA, Wolff J, Nestor B, Frazier E, Massing-Schaffer M, Graves H, Esposito-Smythers C, Spirito A. Parental Monitoring Predicts Depressive Symptom and Suicidal Ideation Outcomes in Adolescents Being Treated for Co-Occurring Substance Use and Psychiatric Disorders. J Affect Disord. 2021 Apr 1;284:190-198. doi: 10.1016/j.jad.2021.02.021. Epub 2021 Feb 9.
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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.
Anthony Spirito, Ph.D. principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Integrated Cognitive Behavioral Therapy in people with Depression and Alcohol Use, run by Brown University at 1 site 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 3 inclusion and 3 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 23 Jan 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Depression (time frame: Measured at 18 months from baseline). 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 NCT01667159, which also lists 2 linked publications.
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 23 Jan 2018.