Substance-Related DisordersNCT01117753
Research on Outpatient Adolescent Treatment for Comorbid Substance Use and Internalizing Disorders
A study testing OutPatient Treatment for Adolescents (OPT-A) and Treatment As Usual in people with Substance-Related Disorders and Depressive Disorder, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Adolescent substance abuse results in significant negative outcomes and extraordinary costs for youths, their families, communities, and society. Moreover, rates of psychiatric comorbidity among substance abusing youth range from 25% up to 82%, and youths with a dual diagnosis are more than twice as costly to treat… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Substance-Related Disorders, Depressive Disorder, Anxiety Disorder
- What is being tested?
- OutPatient Treatment for Adolescents (OPT-A) and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jun 2014
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 10 to 17 years of age
- Residing with at least one adult caregiver who serves as a parent figure
- In need of treatment for a Substance Abuse or Dependence Disorder
- In need of treatment for an Axis I Mood Disorder and/or Anxiety Disorder
Who cannot join
- Pervasive Developmental Disorder
- Active Psychotic Disorder
- Severe or profound mental retardation
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina, Department of Psychiatry & Behavioral Sciences, Family Services Research Center
Charleston, South Carolina, 29425
About this study
Official title: Stage II Research on Outpatient Treatment for Adolescents With Comorbidity
Adolescent substance abuse results in significant negative outcomes and extraordinary costs for youths, their families, communities, and society. Moreover, rates of psychiatric comorbidity among substance abusing youth range from 25% up to 82%, and youths with a dual diagnosis are more than twice as costly to treat compared to those with no comorbidity. The applicant principal investigator recently completed a pilot project funded by the National Institute on Drug Abuse focused on developing and piloting a psychosocial treatment specifically for youth presenting for outpatient treatment with co-occurring substance use and internalizing (i.e., mood and/or anxiety) problems. Results were promising with the experimental group exhibiting significantly less substance use and more rapid reductions in anxiety and depressive symptoms compared to the control group. The proposed research is a randomized clinical trial (RCT) to compare the experimental treatment (OutPatient Treatment for Adolescents; OPT-A) to an "active placebo" on key clinical indices from pre-treatment through 18 months. The proposed RCT (n = 160) employs the treatment manual, quality assurance protocol, and therapist training protocol developed and successfully tested in the pilot study, to evaluate the efficacy of OPT-A for youth referred to outpatient treatment of co-occurring substance use and internalizing problems. The following outcomes will be evaluated: drug use; mental health; behavioral, school, peer, and family functioning; and consumer satisfaction. The intervention addresses one of the more prevalent and most challenging, costly, and understudied presenting problems among adolescent outpatients. If successful, this research could provide a considerable contribution in the treatment field for youth with co-occurring substance use and internalizing disorders.
- Being tested
- OutPatient Treatment for Adolescents (OPT-A), Treatment As Usual
- Medical subject headings
- Substance-Related Disorders, Depressive Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OutPatient Treatment for Adolescents (OPT-A)Behavioural
Treatment As UsualBehavioural
| Study group | Role | What they receive |
|---|---|---|
| OPT-A | Experimental | OPT-A is an outpatient family-based treatment for co-occurring substance use and internalizing disorders Receives: Behavioral: OutPatient Treatment for Adolescents (OPT-A) |
| Treatment as Usual | Active comparator | Treatment as usual in a community based mental health center Receives: Behavioral: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance use
Measured: baseline and 1-, 2-, 3-, 6-, 12-, and 18-month follow-up
Mental Health
Measured: baseline and 1-, 2-, 3-, 6-, 12-, and 18-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startJul 2009
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Ashli J Sheidow, PhD, Principal investigator, Medical University of South Carolina, Department of Psychiatry & Behavioral Sciences, Family Services Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117753
- Sponsor's protocol ID
- MUSC19301.
- Other IDs
- 1R01DA025616-01A1
- Status last verified
- Jun 2026
- First submitted
- 4 May 2010
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stage II Research on Outpatient Treatment for Adolescents With Comorbidity
- ClinicalTrials.gov ID
- NCT01117753
- Acronym / sponsor ID
- MUSC19301.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2009
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 5 May 2010 (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.
Adolescent substance abuse results in significant negative outcomes and extraordinary costs for youths, their families, communities, and society. Moreover, rates of psychiatric comorbidity among substance abusing youth range from 25% up to 82%, and youths with a dual diagnosis are more than twice as costly to treat compared to those with no comorbidity. The applicant principal investigator recently completed a pilot project funded by the National Institute on Drug Abuse focused on developing and piloting a psychosocial treatment specifically for youth presenting for outpatient treatment with co-occurring substance use and internalizing (i.e., mood and/or anxiety) problems. Results were promising with the experimental group exhibiting significantly less substance use and more rapid reductions in anxiety and depressive symptoms compared to the control group. The proposed research is a randomized clinical trial (RCT) to compare the experimental treatment (OutPatient Treatment for Adolescents; OPT-A) to an "active placebo" on key clinical indices from pre-treatment through 18 months. The proposed RCT (n = 160) employs the treatment manual, quality assurance protocol, and therapist training protocol developed and successfully tested in the pilot study, to evaluate the efficacy of OPT-A for youth referred to outpatient treatment of co-occurring substance use and internalizing problems. The following outcomes will be evaluated: drug use; mental health; behavioral, school, peer, and family functioning; and consumer satisfaction. The intervention addresses one of the more prevalent and most challenging, costly, and understudied presenting problems among adolescent outpatients. If successful, this research could provide a considerable contribution in the treatment field for youth with co-occurring substance use and internalizing disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPT-A | Experimental | Behavioral: OutPatient Treatment for Adolescents (OPT-A)OPT-A is an outpatient family-based treatment for co-occurring substance use and internalizing disorders |
| Treatment as Usual | Active comparator | Behavioral: Treatment As UsualTreatment as usual in a community based mental health center |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 10 to 17 years of age
- Residing with at least one adult caregiver who serves as a parent figure
- In need of treatment for a Substance Abuse or Dependence Disorder
- In need of treatment for an Axis I Mood Disorder and/or Anxiety Disorder
Key exclusion criteria (3 listed)
- Pervasive Developmental Disorder
- Active Psychotic Disorder
- Severe or profound mental retardation
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 |
|---|---|---|
| OutPatient Treatment for Adolescents (OPT-A) | Behavioural | OPT-A |
| Treatment As Usual | Behavioural | Treatment as Usual |
Primary outcome
Substance use
Time frame: baseline and 1-, 2-, 3-, 6-, 12-, and 18-month follow-up
Mental Health
Time frame: baseline and 1-, 2-, 3-, 6-, 12-, and 18-month 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 Jun 2026.
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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.
Ashli J Sheidow, PhD principal investigator
Medical University of South Carolina, Department of Psychiatry & Behavioral Sciences, Family Services Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OutPatient Treatment for Adolescents (OPT-A) and Treatment As Usual in people with Substance-Related Disorders and Depressive Disorder, run by Medical University of South Carolina 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 4 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 12 Jun 2026. 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?
Substance use (time frame: baseline and 1-, 2-, 3-, 6-, 12-, and 18-month follow-up). The study lists 2 primary outcomes in all. 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 Jun 2026.