AdolescentSequencingNCT00680966
Sequenced vs. Integrated Delivery of Treatment for Adolescent Depression and SUD
A study testing Adolescent Coping With Depression/Functional Family Therapy in people with Adolescent and Depression, run by Oregon Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine whether it is more effective to treat adolescents, with diagnoses of both depression and substance use disorder, with a treatment addressing the substance use first and then treating the depression or to first treat the depression and then treat the substance use or whether… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Adolescent, Depression, Substance Use Disorders
- What is being tested?
- Adolescent Coping With Depression/Functional Family Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jun 2013
- 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 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- DSM-IV-TR diagnosis of depression, defined as MDD, dysthymia, or substance-induced mood disorder meeting MDD or dysthymia symptom criteria
- DSM-IV-TR diagnosis of one or more non-nicotine SUD
- Some reported illicit drug use in the last 90 days
- 13-17 years of age
- parent or guardian willing to participate in study
- basic English competency (ability to converse in English)
Who cannot join
- Current and acute suicidal ideation at the level warranting inpatient treatment
- current psychotic symptoms
- the adolescent's sibling is already participating in the study
- if on psychiatric medications, a significant change in dosage levels in the prior 4 weeks -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether it is more effective to treat adolescents, with diagnoses of both depression and substance use disorder, with a treatment addressing the substance use first and then treating the depression or to first treat the depression and then treat the substance use or whether treating both disorders simultaneously is most effective.
It is expected that treatment of both disorders at the same time will be the most effective.
Read the detailed description
Comorbidity is a well established aspect of adolescent psychopathology. The majority of adolescents entering treatment have more than one condition. This study will evaluate service delivery methods of integrating empirically supported interventions for depression and non-nicotine substance use disorders (SUD)in an effort to improve treatment engagement, response, and maintenance of gains. The two examined interventions are the Adolescent Coping With Depression course (ACWD) and Functional Family Therapy (FFT).
This study will expand upon previous research by systematically treating both depression and SUD. Over a 5 year period, 180 adolescents with depression/SUD and their parents/guardians will be recruited in Oregon and New Mexico and randomly assigned to 1 of 3 conditions: (a) FFT followed by ACWD, (b) ACWD followed by FFT, or (c) an intervention combining and augmenting FFT and ACWD (Integrated Treatment). Each treatment arm will consist of 24 sessions provided over 20 weeks. Participants will be assessed at intake, after the provision of 6, 12 (Mid-treatment), 18 and 24 (Post-treatment)treatment sessions, and at 6 and 12 month follow-ups.
- Conditions
- Adolescent, Depression, Substance Use Disorders
- Being tested
- Adolescent Coping With Depression/Functional Family Therapy
- Keywords
- Treatment efficacy, Family therapy, Teens, Substance abuse, Substance dependence
- Medical subject headings
- Depression, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adolescent Coping With Depression/Functional Family TherapyBehavioural
Also called FFT, ACWD
ACWD- Cognitive behavioral group therapy for depressed adolescents FFT - Family therapy to address substance use disorders in adolescents
| Study group | Role | What they receive |
|---|---|---|
| TX1 | Experimental | Functional Family Therapy (FFT) followed by Adolescent Coping With Depression (ACWD) Receives: Behavioral: Adolescent Coping With Depression/Functional Family Therapy |
| TX 2 | Experimental | ACWD (Adolescent Coping With Depression) followed by FFT (Functional Family Therapy) Receives: Behavioral: Adolescent Coping With Depression/Functional Family Therapy |
| TX 3 | Experimental | Combination of an augmented FFT and ACWD - Integrated treatment Receives: Behavioral: Adolescent Coping With Depression/Functional Family Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Depression Rating Scale
Measured: Intake, Mid-Treatment, Post, 6 months and 12 months follow-up
Secondary outcomes (1)
Time Life Follow Back
Measured: Intake, Mid-Treatment, Post, 6 months and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdolescentStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul D Rohde, Ph. D., Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680966
- Sponsor's protocol ID
- DA021357
- Other IDs
- 1R01DA021357
- Acronym
- Sequencing
- Status last verified
- Mar 2014
- First submitted
- 16 May 2008
- Last updated
- 12 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequenced vs. Integrated Delivery of Treatment for Adolescent Depression and SUD
- ClinicalTrials.gov ID
- NCT00680966
- Acronym / sponsor ID
- Sequencing / DA021357
- Conditions
- Adolescent, Depression, Substance Use Disorders
- Keywords
- Treatment efficacy, Family therapy, Teens, Substance abuse, Substance dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 20 May 2008 (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 purpose of this study is to determine whether it is more effective to treat adolescents, with diagnoses of both depression and substance use disorder, with a treatment addressing the substance use first and then treating the depression or to first treat the depression and then treat the substance use or whether treating both disorders simultaneously is most effective.
It is expected that treatment of both disorders at the same time will be the most effective.
Detailed description
Comorbidity is a well established aspect of adolescent psychopathology. The majority of adolescents entering treatment have more than one condition. This study will evaluate service delivery methods of integrating empirically supported interventions for depression and non-nicotine substance use disorders (SUD)in an effort to improve treatment engagement, response, and maintenance of gains. The two examined interventions are the Adolescent Coping With Depression course (ACWD) and Functional Family Therapy (FFT).
This study will expand upon previous research by systematically treating both depression and SUD. Over a 5 year period, 180 adolescents with depression/SUD and their parents/guardians will be recruited in Oregon and New Mexico and randomly assigned to 1 of 3 conditions: (a) FFT followed by ACWD, (b) ACWD followed by FFT, or (c) an intervention combining and augmenting FFT and ACWD (Integrated Treatment). Each treatment arm will consist of 24 sessions provided over 20 weeks. Participants will be assessed at intake, after the provision of 6, 12 (Mid-treatment), 18 and 24 (Post-treatment)treatment sessions, and at 6 and 12 month follow-ups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TX1 | Experimental | Behavioral: Adolescent Coping With Depression/Functional Family TherapyFunctional Family Therapy (FFT) followed by Adolescent Coping With Depression (ACWD) |
| TX 2 | Experimental | Behavioral: Adolescent Coping With Depression/Functional Family TherapyACWD (Adolescent Coping With Depression) followed by FFT (Functional Family Therapy) |
| TX 3 | Experimental | Behavioral: Adolescent Coping With Depression/Functional Family TherapyCombination of an augmented FFT and ACWD - Integrated treatment |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- DSM-IV-TR diagnosis of depression, defined as MDD, dysthymia, or substance-induced mood disorder meeting MDD or dysthymia symptom criteria
- DSM-IV-TR diagnosis of one or more non-nicotine SUD
- Some reported illicit drug use in the last 90 days
- 13-17 years of age
- parent or guardian willing to participate in study
Key exclusion criteria (4 listed)
- Current and acute suicidal ideation at the level warranting inpatient treatment
- current psychotic symptoms
- the adolescent's sibling is already participating in the study
- if on psychiatric medications, a significant change in dosage levels in the prior 4 weeks -
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 |
|---|---|---|
| Adolescent Coping With Depression/Functional Family TherapyAlso: FFT, ACWDACWD- Cognitive behavioral group therapy for depressed adolescents FFT - Family therapy to address substance use disorders in adolescents | Behavioural | TX 2, TX 3, TX1 |
Primary outcome
Children's Depression Rating Scale
Time frame: Intake, Mid-Treatment, Post, 6 months and 12 months follow-up
1 secondary outcome
Time Life Follow Back
Time frame: Intake, Mid-Treatment, Post, 6 months and 12 months follow-up
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 12 Mar 2014.
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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.
Paul D Rohde, Ph. D. principal investigator
Oregon Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adolescent Coping With Depression/Functional Family Therapy in people with Adolescent and Depression, run by Oregon Research Institute 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 6 inclusion and 4 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 12 Mar 2014. 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.
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?
Children's Depression Rating Scale (time frame: Intake, Mid-Treatment, Post, 6 months and 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2014.