Substance Use DisorderPhase 1MAST1NCT01616212
Early Intervention for Minors in Possession of Alcohol/Drugs: A Feasibility Study
A Phase 1 study testing Motivational Enhancement Therapy /Adol and PW for parents, Motivational Enhancement Therapy for adolescents and Drug Education for adolescents, Parenting Wisely for parents in people with Substance Use Disorder and Delinquency, run by Oregon Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to evaluate two brief, sustainable interventions for a sample of 280 adolescents charged with an initial drug-related offense: Motivational Enhancement Therapy (MET) intervention for youth and the Parenting Wisely (PW) intervention for parents. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorder, Delinquency
- What is being tested?
- Motivational Enhancement Therapy /Adol and PW for parents, Motivational Enhancement Therapy for adolescents and Drug Education for adolescents, Parenting Wisely for parents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Sep 2014
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 13 - 17 years of age
- Referral for a 1st or 2nd Minor in Possession (Alcohol) or Less Than an Ounce (Marijuana) offense
- Adolescents living at home with at least one parent willing to participate in the study
- Adolescents with sufficient English-language ability to permit participation in the interventions
- Parent(s) with sufficient English- or Spanish-language ability to complete the English- or Spanish-language versions of PW and the assessment
Who cannot join
- Evidence of psychotic or organic state of sufficient severity to interfere with understanding study procedures
- Danger to self and/or services other than outpatient treatment are required
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate two brief, sustainable interventions for a sample of 280 adolescents charged with an initial drug-related offense: Motivational Enhancement Therapy (MET) intervention for youth and the Parenting Wisely (PW) intervention for parents. Families are assessed for adolescent substance use, HIV-risk, recidivist substance-related offenses, treatment entry, and other areas of individual and family functioning.
It is expected that the combined MET+PW interventions will be more effective than a treatment-as-usual intervention (drug education group) for adolescents with parents not participating in PW.
Read the detailed description
Illicit substance use and related problems among adolescents has been consistently high over the past decade and remains one of the most pressing public health concerns in the United States. The objective of this study is to conduct a pilot investigation of the feasibility and effectiveness of two brief empirically based treatments for adolescent substance abuse when implemented as early interventions for youth arrested and charged with first- or second-offense possession of alcohol or drugs. The two examined interventions are Motivational Enhancement therapy (MET) and Parenting Wisely (PW).
Over a one-year period, 280 adolescents and their parents will be referred to the study by the Juvenile Justice Centers in two Oregon counties within the Portland metro area. Families will be randomized to one of four intervention conditions; youth will receive either MET or a drug education intervention (EDUC), and the PW intervention for parents is present or absent. Participants will be assessed for adolescent substance use, HIV-risk, recidivist substance-related offenses, treatment entry, and other areas of individual and family functioning at intake and at 3- and 6-month follow-ups.
- Conditions
- Substance Use Disorder, Delinquency
- Being tested
- Motivational Enhancement Therapy /Adol and PW for parents, Motivational Enhancement Therapy for adolescents, Drug Education for adolescents, Parenting Wisely for parents, Drug Education for adolescents
- Keywords
- Teens, Parenting, Substance Abuse, Treatment Efficacy
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Enhancement Therapy /Adol and PW for parentsOther
Also called MET / PW
Motivational Enhancement Therapy for adolescents, Parenting Wisely for parents
Motivational Enhancement Therapy for adolescentsOther
Also called MET
Motivational Enhancement Therapy for adolescents
Drug Education for adolescents, Parenting Wisely for parentsOther
Also called EDUC / PW
Drug Education for adolescents, Parenting Wisely for parents
Drug Education for adolescentsOther
Also called EDUC
Drug Education for adolescents
| Study group | Role | What they receive |
|---|---|---|
| TX1 | Experimental | Motivational Enhancement Therapy for adolescents, Parenting Wisely for parents Receives: Other: Motivational Enhancement Therapy /Adol and PW for parents |
| TX 2 | Experimental | Motivational Enhancement Therapy for adolescents Receives: Other: Motivational Enhancement Therapy for adolescents |
| TX3 | Experimental | Drug Education for adolescents, Parenting Wisely for parents Receives: Other: Drug Education for adolescents, Parenting Wisely for parents |
| TX4 | Experimental | Drug Education for adolescents Receives: Other: Drug Education for adolescents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescent Substance Use and Related Problems
The questionnaire used is called the Time Line Follow Back.
Measured: Change from Baseline at 6 months
Secondary outcomes (1)
Dysfunctional Discipline Practices
The questionnaire used to obtain this information is called Parenting Scale.
Measured: Change from Baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startJul 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisorderStudies 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
- None (open label)
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hyman Hops, Ph.D., Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616212
- Sponsor's protocol ID
- DA-12-033
- Acronym
- MAST1
- Status last verified
- Oct 2014
- First submitted
- 29 May 2012
- Last updated
- 10 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention for Minors in Possession of Alcohol/Drugs: A Feasibility Study
- ClinicalTrials.gov ID
- NCT01616212
- Acronym / sponsor ID
- MAST1 / DA-12-033
- Conditions
- Substance Use Disorder, Delinquency
- Keywords
- Teens, Parenting, Substance Abuse, Treatment Efficacy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 11 Jun 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.
The purpose of this study is to evaluate two brief, sustainable interventions for a sample of 280 adolescents charged with an initial drug-related offense: Motivational Enhancement Therapy (MET) intervention for youth and the Parenting Wisely (PW) intervention for parents. Families are assessed for adolescent substance use, HIV-risk, recidivist substance-related offenses, treatment entry, and other areas of individual and family functioning.
It is expected that the combined MET+PW interventions will be more effective than a treatment-as-usual intervention (drug education group) for adolescents with parents not participating in PW.
Detailed description
Illicit substance use and related problems among adolescents has been consistently high over the past decade and remains one of the most pressing public health concerns in the United States. The objective of this study is to conduct a pilot investigation of the feasibility and effectiveness of two brief empirically based treatments for adolescent substance abuse when implemented as early interventions for youth arrested and charged with first- or second-offense possession of alcohol or drugs. The two examined interventions are Motivational Enhancement therapy (MET) and Parenting Wisely (PW).
Over a one-year period, 280 adolescents and their parents will be referred to the study by the Juvenile Justice Centers in two Oregon counties within the Portland metro area. Families will be randomized to one of four intervention conditions; youth will receive either MET or a drug education intervention (EDUC), and the PW intervention for parents is present or absent. Participants will be assessed for adolescent substance use, HIV-risk, recidivist substance-related offenses, treatment entry, and other areas of individual and family functioning at intake and at 3- and 6-month follow-ups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TX1 | Experimental | Other: Motivational Enhancement Therapy /Adol and PW for parentsMotivational Enhancement Therapy for adolescents, Parenting Wisely for parents |
| TX 2 | Experimental | Other: Motivational Enhancement Therapy for adolescentsMotivational Enhancement Therapy for adolescents |
| TX3 | Experimental | Other: Drug Education for adolescents, Parenting Wisely for parentsDrug Education for adolescents, Parenting Wisely for parents |
| TX4 | Experimental | Other: Drug Education for adolescentsDrug Education for adolescents |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 13 - 17 years of age
- Referral for a 1st or 2nd Minor in Possession (Alcohol) or Less Than an Ounce (Marijuana) offense
- Adolescents living at home with at least one parent willing to participate in the study
- Adolescents with sufficient English-language ability to permit participation in the interventions
- Parent(s) with sufficient English- or Spanish-language ability to complete the English- or Spanish-language versions of PW and the assessment
Key exclusion criteria (2 listed)
- Evidence of psychotic or organic state of sufficient severity to interfere with understanding study procedures
- Danger to self and/or services other than outpatient treatment are required
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 |
|---|---|---|
| Motivational Enhancement Therapy /Adol and PW for parentsAlso: MET / PWMotivational Enhancement Therapy for adolescents, Parenting Wisely for parents | Other | TX1 |
| Motivational Enhancement Therapy for adolescentsAlso: METMotivational Enhancement Therapy for adolescents | Other | TX 2 |
| Drug Education for adolescents, Parenting Wisely for parentsAlso: EDUC / PWDrug Education for adolescents, Parenting Wisely for parents | Other | TX3 |
| Drug Education for adolescentsAlso: EDUCDrug Education for adolescents | Other | TX4 |
Primary outcome
Adolescent Substance Use and Related Problems
Time frame: Change from Baseline at 6 months
The questionnaire used is called the Time Line Follow Back.
1 secondary outcome
Dysfunctional Discipline Practices
Time frame: Change from Baseline at 6 months
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 10 Oct 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.
Hyman Hops, 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 Phase 1 study testing Motivational Enhancement Therapy /Adol and PW for parents, Motivational Enhancement Therapy for adolescents and Drug Education for adolescents, Parenting Wisely for parents in people with Substance Use Disorder and Delinquency, 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 5 inclusion and 2 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 10 Oct 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.
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?
Adolescent Substance Use and Related Problems (time frame: Change from Baseline at 6 months). 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 10 Oct 2014.