Substance-Related DisordersPhase 1NCT00438685
Outpatient Adolescent Treatment for Comorbid Substance Use and Internalizing Disorders
A Phase 1 study testing Outpatient MST/OPTION-A and Usual Services 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 have worse outcomes and are more than… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Substance-Related Disorders, Depressive Disorder, Anxiety Disorder
- What is being tested?
- Outpatient MST/OPTION-A and Usual Services
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Sep 2010
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Presentation for outpatient treatment
- 12 to 17 years of age
- Youth residing with at least one adult caregiver who serves as a parent figure
- Substance Abuse or Dependence Disorder
- Axis I Internalizing Disorder (Mood Disorder or Anxiety Disorder), based on the Diagnostic Interview Schedule for Children (DISC-IV; Shaffer, Fisher, Lucas, Dulcan, \& Schwab-Stone, 2000)
Who cannot join
- Pervasive Developmental Disorder
- Psychotic Disorder
- Severe or profound mental retardation (IQ of 45 or below)
- Families previously receiving Multisystemic Therapy
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: Development of Outpatient MST for Dually Diagnosed Youth
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 have worse outcomes and are more than twice as costly to treat than their counterparts with no comorbidity. This project was a pilot test of a new treatment, OPTION-A, which was adapted from Multisystemic Therapist (MST) and other evidence-based interventions to specifically treat youth presenting for outpatient treatment of comorbid substance use and internalizing disorders. The project was a randomized controlled pilot trial comparing the experimental treatment to usual services in the community.
Read the detailed description
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 are high and youths with a dual diagnosis are more costly to treat. At the time of this study, however, no outpatient treatments had been tested specifically for treating youth with co-occurring substance use disorders and mental health diagnoses. The current project aimed to adapt and evaluate Multisystemic Therapy (MST), a well validated treatment for chronic behavioral problems or serious emotional disturbance in adolescents, to treat dually diagnosed youth using an outpatient model of service delivery.
A pilot trial was conducted with 40 dually diagnosed youth randomly assigned to treatment conditions, with 20 receiving the experimental treatment (OPTION-A) and 20 receiving usual outpatient services. Specific aims were:
Specific Aim 1: The primary aim of the present research was to adapt and test OPTION-A for use in outpatient settings to treat youth diagnosed with a substance use disorder and comorbid internalizing disorder. We hypothesized that youth receiving OPTION-A would exhibit significantly less drug use (e.g., youth self-reports and urine screens) than control youth who received usual services, and that youth receiving OPTION-A would exhibit significant improvement on indices of mental health (e.g., combined youth and caregiver reports on diagnostic interviews and youth, caregiver, and teacher reports of internalizing symptoms) compared to control youth Specific Aim 2: In addition to improved symptomatology, the current research aimed to test the effectiveness of OPTION-A to improve youth functioning in other domains pertinent to successful adolescent development. We hypothesized that youth receiving OPTION-A would evidence improved behavioral (e.g., youth, caregiver, and teacher reports of externalizing), school (e.g., school attendance), and family functioning (e.g., youth and caregiver reports of family adaptability and cohesion) compared to control youth who received usual services.
Specific Aim 3: The final aim of the proposed research was to provide services that are more acceptable to consumers than are usual services provided in the community. We hypothesized that youth and families receiving OPTION-A would experience significantly greater consumer satisfaction than control youth and families who received usual services.
- Being tested
- Outpatient MST/OPTION-A, Usual Services
- Keywords
- Substance-Related Disorders, Depressive Disorder, Anxiety Disorder, Adolescent, Behavior Therapy, Cognitive Therapy, Outpatients, Family Relations, Systems Theory
- 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 MST/OPTION-ABehavioural
Usual ServicesBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Drug Screen at 4 weeks, 8 weeks, 12 weeks, 24 weeks
Score on Depression/Anxiety Scale (RCADS) at 4 weeks, 8 weeks, 12 weeks, 24 weeks
Secondary outcomes (8)
Measured at Intake, 3 Months, and 6 Months
Global assessment of symptoms
Parenting
School
Behavioral
Family relationship/communication/problem solving
Consumer satisfaction
Daily Drug/Alcohol use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
- Study startOct 2004
- Primary completionAug 2007
- Study completionSep 2010
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Investigators
- Ashli J Sheidow, PhD, Principal investigator, Medical University of South Carolina, Department of Psychiatry & Behavioral Sciences, Family Services Research CenterScott W Henggeler, PhD, Study chair, Medical University of South Carolina, Department of Psychiatry & Behavioral Sciences, Family Services Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438685
- Sponsor's protocol ID
- 1R21DA017118-01
- Other IDs
- R21DA017118
- Status last verified
- Jul 2010
- First submitted
- 21 Feb 2007
- Last updated
- 14 Jun 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Outpatient MST for Dually Diagnosed Youth
- ClinicalTrials.gov ID
- NCT00438685
- Acronym / sponsor ID
- 1R21DA017118-01
- Keywords
- Substance-Related Disorders, Depressive Disorder, Anxiety Disorder, Adolescent, Behavior Therapy, Cognitive Therapy, Outpatients, Family Relations
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2004
- Primary completion
- Aug 2007 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 22 Feb 2007 (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 have worse outcomes and are more than twice as costly to treat than their counterparts with no comorbidity. This project was a pilot test of a new treatment, OPTION-A, which was adapted from Multisystemic Therapist (MST) and other evidence-based interventions to specifically treat youth presenting for outpatient treatment of comorbid substance use and internalizing disorders. The project was a randomized controlled pilot trial comparing the experimental treatment to usual services in the community.
Detailed description
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 are high and youths with a dual diagnosis are more costly to treat. At the time of this study, however, no outpatient treatments had been tested specifically for treating youth with co-occurring substance use disorders and mental health diagnoses. The current project aimed to adapt and evaluate Multisystemic Therapy (MST), a well validated treatment for chronic behavioral problems or serious emotional disturbance in adolescents, to treat dually diagnosed youth using an outpatient model of service delivery.
A pilot trial was conducted with 40 dually diagnosed youth randomly assigned to treatment conditions, with 20 receiving the experimental treatment (OPTION-A) and 20 receiving usual outpatient services. Specific aims were:
Specific Aim 1: The primary aim of the present research was to adapt and test OPTION-A for use in outpatient settings to treat youth diagnosed with a substance use disorder and comorbid internalizing disorder. We hypothesized that youth receiving OPTION-A would exhibit significantly less drug use (e.g., youth self-reports and urine screens) than control youth who received usual services, and that youth receiving OPTION-A would exhibit significant improvement on indices of mental health (e.g., combined youth and caregiver reports on diagnostic interviews and youth, caregiver, and teacher reports of internalizing symptoms) compared to control youth Specific Aim 2: In addition to improved symptomatology, the current research aimed to test the effectiveness of OPTION-A to improve youth functioning in other domains pertinent to successful adolescent development. We hypothesized that youth receiving OPTION-A would evidence improved behavioral (e.g., youth, caregiver, and teacher reports of externalizing), school (e.g., school attendance), and family functioning (e.g., youth and caregiver reports of family adaptability and cohesion) compared to control youth who received usual services.
Specific Aim 3: The final aim of the proposed research was to provide services that are more acceptable to consumers than are usual services provided in the community. We hypothesized that youth and families receiving OPTION-A would experience significantly greater consumer satisfaction than control youth and families who received usual services.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Presentation for outpatient treatment
- 12 to 17 years of age
- Youth residing with at least one adult caregiver who serves as a parent figure
- Substance Abuse or Dependence Disorder
- Axis I Internalizing Disorder (Mood Disorder or Anxiety Disorder), based on the Diagnostic Interview Schedule for Children (DISC-IV; Shaffer, Fisher, Lucas, Dulcan, \& Schwab-Stone, 2000)
Key exclusion criteria (4 listed)
- Pervasive Developmental Disorder
- Psychotic Disorder
- Severe or profound mental retardation (IQ of 45 or below)
- Families previously receiving Multisystemic Therapy
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 MST/OPTION-A | Behavioural | – |
| Usual Services | Behavioural | – |
Primary outcome
Urine Drug Screen at 4 weeks, 8 weeks, 12 weeks, 24 weeks
Score on Depression/Anxiety Scale (RCADS) at 4 weeks, 8 weeks, 12 weeks, 24 weeks
8 secondary outcomes
Measured at Intake, 3 Months, and 6 Months
Global assessment of symptoms
Parenting
School
Behavioral
Family relationship/communication/problem solving
Consumer satisfaction
Daily Drug/Alcohol use
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 14 Jun 2018.
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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
Scott W Henggeler, PhD study chair
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 Phase 1 study testing Outpatient MST/OPTION-A and Usual Services 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 5 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 14 Jun 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?
Urine Drug Screen at 4 weeks, 8 weeks, 12 weeks, 24 weeks. 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 14 Jun 2018.