Substance-related DisordersPhase 1/2NCT00891631
Primary Care iSBIRT to Reduce Serious Teen Health Risks
A Phase 1/2 study testing iSBIRT and iSBIRT/TE in people with Substance-related Disorders and Depression, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The goal of the project is to develop and test an internet/intranet-based Screening, Brief Intervention, and Referral to Treatment (iSBIRT) system for adolescents that targets a broad range of serious health-risks and problem behaviors. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Substance-related Disorders, Depression, High-risk Sex
- What is being tested?
- iSBIRT and iSBIRT/TE
- 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
- Sep 2009to Sep 2011
- Phase
- Phase 1/2
- 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
- 12-21 years old
- arriving for non-urgent care
- provide informed assent/consent
Who cannot join
- less than 6th grade reading level
- unavailable for follow-up questionnaires
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: Primary Care Internet/Intranet-based Screening, Brief Intervention, and Referral to Treatment (iSBIRT) System to Reduce Serious Teen Health Risks
The goal of the project is to develop and test an internet/intranet-based Screening, Brief Intervention, and Referral to Treatment (iSBIRT) system for adolescents that targets a broad range of serious health-risks and problem behaviors.
Read the detailed description
We have previously developed and tested a computerized substance use screening and feedback program for adolescents. We will expand this program to include other serious health risks, enhance the feedback and health risk information adolescents will receive on the computer, develop Technological Extenders to extend the effect of the intervention, develop a training video and protocol for providers, and pilot test the system among adolescents coming for non-urgent care at a variety of primary care sites.
- Conditions
- Substance-related Disorders, Depression, High-risk Sex
- Being tested
- iSBIRT, iSBIRT/TE
- Keywords
- tobacco, alcohol, marijuana, drug use, seat-belt, weapons, depression, suicidality, sexual risk behaviors
- Medical subject headings
- Substance-Related Disorders, Depression, Unsafe Sex, Marijuana Abuse, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iSBIRTBehavioural
Also called SBIRT
Participants will receive the internet/intranet based screening, brief intervention, and referral to treatment program.
iSBIRT/TEBehavioural
Also called SBIRT
Participants will receive the internet/intranet screening, brief intervention, and referral to treatment system along with technological extenders
| Study group | Role | What they receive |
|---|---|---|
| iSBIRT | Experimental | Participants will complete the iSBIRT system. Receives: Behavioral: iSBIRT |
| iSBIRT/TE | Experimental | Participants will receive the internet/intranet screening, brief intervention, and referral to treatment system and technological extenders Receives: Behavioral: iSBIRT/TE |
| TAU | No intervention | Participants will receive Treatment as Usual from their primary care provider. |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of substance use and other risk behaviors
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Why it stopped: Grant application was not funded
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 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 1/2
- Primary purpose
- Screening
- 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, John R Knight, MD, Boston Children's Hospital
- Investigators
- John R Knight, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891631
- Sponsor's protocol ID
- iSBIRT RFA-od-09-003
- Status last verified
- Oct 2016
- First submitted
- 30 Apr 2009
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Internet/Intranet-based Screening, Brief Intervention, and Referral to Treatment (iSBIRT) System to Reduce Serious Teen Health Risks
- ClinicalTrials.gov ID
- NCT00891631
- Acronym / sponsor ID
- iSBIRT RFA-od-09-003
- Conditions
- Substance-related Disorders, Depression, High-risk Sex
- Keywords
- tobacco, alcohol, marijuana, drug use, seat-belt, weapons, depression, suicidality
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Grant application was not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 1 May 2009 (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 goal of the project is to develop and test an internet/intranet-based Screening, Brief Intervention, and Referral to Treatment (iSBIRT) system for adolescents that targets a broad range of serious health-risks and problem behaviors.
Detailed description
We have previously developed and tested a computerized substance use screening and feedback program for adolescents. We will expand this program to include other serious health risks, enhance the feedback and health risk information adolescents will receive on the computer, develop Technological Extenders to extend the effect of the intervention, develop a training video and protocol for providers, and pilot test the system among adolescents coming for non-urgent care at a variety of primary care sites.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| iSBIRT | Experimental | Behavioral: iSBIRTParticipants will complete the iSBIRT system. |
| iSBIRT/TE | Experimental | Behavioral: iSBIRT/TEParticipants will receive the internet/intranet screening, brief intervention, and referral to treatment system and technological extenders |
| TAU | No intervention | –Participants will receive Treatment as Usual from their primary care provider. |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 12-21 years old
- arriving for non-urgent care
- provide informed assent/consent
Key exclusion criteria (2 listed)
- less than 6th grade reading level
- unavailable for follow-up questionnaires
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 |
|---|---|---|
| iSBIRTAlso: SBIRTParticipants will receive the internet/intranet based screening, brief intervention, and referral to treatment program. | Behavioural | iSBIRT |
| iSBIRT/TEAlso: SBIRTParticipants will receive the internet/intranet screening, brief intervention, and referral to treatment system along with technological extenders | Behavioural | iSBIRT/TE |
Primary outcome
frequency of substance use and other risk behaviors
Time frame: 3 months
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 7 Oct 2016.
- Web site of the Center for Adolescent Substance Abuse Research at Children's Hospital BostonLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Substance-related Disorders
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
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.
John R Knight, MD 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 1/2 study testing iSBIRT and iSBIRT/TE in people with Substance-related Disorders and Depression, 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 3 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 7 Oct 2016. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
frequency of substance use and other risk behaviors (time frame: 3 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 7 Oct 2016.