Drug AbusePhase 1NCT01784653
Trial of Computerized MET for Adolescent Substance Use
A Phase 1 study testing iMET and MET in people with Drug Abuse and Alcohol Abuse, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to test the effects of a computerized, self-directed Motivational Enhancement Therapy program for adolescent substance use (iMET), in comparison to clinician-delivered MET and Treatment As Usual (TAU), on treatment engagement and substance use. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Drug Abuse, Alcohol Abuse, Nicotine Dependence
- What is being tested?
- iMET and MET
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jan 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- completed initial visit at the treatment program;
- be available to return for iMET/MET sessions (if assigned)
- be available to complete all follow-up measurements
- a past-12-month CRAFFT score >1
- have used substances on >6 days (not including tobacco use) during the 90 days preceding their visit
Who cannot join
- unable to speak and understand English, or read English at a 5th grade reading level
- youth deemed by the clinical team to require immediate hospitalization or referral to more intensive residential treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Randomized Controlled Trial of Computerized MET for Adolescent Substance Use
The purpose of this study is to test the effects of a computerized, self-directed Motivational Enhancement Therapy program for adolescent substance use (iMET), in comparison to clinician-delivered MET and Treatment As Usual (TAU), on treatment engagement and substance use. The investigators hypothesize that both iMET and MET will be more effective than TAU in engaging/retaining patients in treatment and in reducing substance use during a 12-month follow-up period. The investigators also hypothesize that Self-directed iMET will be as effective as the clinician-guided MET in increasing treatment engagement and abstinence during the 12-months follow-up period.
- Conditions
- Drug Abuse, Alcohol Abuse, Nicotine Dependence
- Being tested
- iMET, MET
- Keywords
- Substance abuse, Drug abuse, Alcohol abuse, Tobacco, Adolescent
- Medical subject headings
- Substance-Related Disorders, Alcoholism, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iMETBehavioural
Self-completed, computerized motivational enhancement therapy
METBehavioural
Clinician-delivered Motivational Enhancement Therapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | No intervention | Patients will receive the usual care from the treatment program |
| iMET | Experimental | Participants will complete a self-guided computerized Motivational Enhancement Therapy Receives: Behavioral: iMET |
| MET | Experimental | Clinician-delivered Motivational Enhancement Therapy Receives: Behavioral: MET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment engagement
We will compare the number of individual visits in the program, the number of group sessions completed, and the number of urine screens completed during a 12 month follow-up period by each participant in the three study arms.
Measured: 12 months
Secondary outcomes (3)
Days abstinent
We will calculate the past-90-days number of days abstinent from any substance use and from the primary substance and the number of weeks abstinent from any substance use.
Measured: past-90-days
Driving/Riding Risk
We will compare group trends in prevalence and frequency of past-90-days Driving while impaired or Riding with an impaired driver.
Measured: past-90-days
HIV Risk Behavior
We will compare group trends in prevalence and frequency of past-90-days HIV Risk Behaviors.
Measured: past-90-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2017 (estimated)
Why it stopped: No funding obtained.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AbuseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sion Kim Harris, Boston Children's Hospital
- Investigators
- Sion K Harris, PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784653
- Sponsor's protocol ID
- SKH R01 PA-13-077
- Status last verified
- Apr 2017
- First submitted
- 4 Feb 2013
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Computerized MET for Adolescent Substance Use
- ClinicalTrials.gov ID
- NCT01784653
- Acronym / sponsor ID
- SKH R01 PA-13-077
- Conditions
- Drug Abuse, Alcohol Abuse, Nicotine Dependence
- Keywords
- Substance abuse, Drug abuse, Alcohol abuse, Tobacco, Adolescent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding obtained.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jan 2017 (estimated)
- First posted
- 6 Feb 2013 (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 test the effects of a computerized, self-directed Motivational Enhancement Therapy program for adolescent substance use (iMET), in comparison to clinician-delivered MET and Treatment As Usual (TAU), on treatment engagement and substance use. The investigators hypothesize that both iMET and MET will be more effective than TAU in engaging/retaining patients in treatment and in reducing substance use during a 12-month follow-up period. The investigators also hypothesize that Self-directed iMET will be as effective as the clinician-guided MET in increasing treatment engagement and abstinence during the 12-months follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | No intervention | –Patients will receive the usual care from the treatment program |
| iMET | Experimental | Behavioral: iMETParticipants will complete a self-guided computerized Motivational Enhancement Therapy |
| MET | Experimental | Behavioral: METClinician-delivered Motivational Enhancement Therapy |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- completed initial visit at the treatment program;
- be available to return for iMET/MET sessions (if assigned)
- be available to complete all follow-up measurements
- a past-12-month CRAFFT score >1
- have used substances on >6 days (not including tobacco use) during the 90 days preceding their visit
Key exclusion criteria (2 listed)
- unable to speak and understand English, or read English at a 5th grade reading level
- youth deemed by the clinical team to require immediate hospitalization or referral to more intensive residential treatment
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 |
|---|---|---|
| iMETSelf-completed, computerized motivational enhancement therapy | Behavioural | iMET |
| METClinician-delivered Motivational Enhancement Therapy | Behavioural | MET |
Primary outcome
Treatment engagement
Time frame: 12 months
We will compare the number of individual visits in the program, the number of group sessions completed, and the number of urine screens completed during a 12 month follow-up period by each participant in the three study arms.
3 secondary outcomes
Days abstinent
Time frame: past-90-days
Driving/Riding Risk
Time frame: past-90-days
HIV Risk Behavior
Time frame: past-90-days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
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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.
Sion K Harris, PhD principal investigator
Boston Children's Hospital
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 iMET and MET in people with Drug Abuse and Alcohol Abuse, run by Boston Children's Hospital 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: withdrawn, as of the sponsor's last update on 12 Apr 2017. 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 was withdrawn before enrolling participants, so there are no results.
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?
Treatment engagement (time frame: 12 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 12 Apr 2017.