Substance UsePhase 2/3NCT01454206
Integration of (iSBIRT) for Teen Drug Use Into a Pediatric Network
A Phase 2/3 study testing iSBIRT in people with Substance Use, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The Goal of this project is to integrate a previously-tested internet-facilitated Screening, Brief Intervention, and Referral to Treatment (iSBIRT) system for adolescent substance use into a large network of primary care offices, the Pediatric Practices of Children's Hospital Boston (PPOC). Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use
- What is being tested?
- iSBIRT
- 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
- Jul 2012to Dec 2016
- Phase
- Phase 2/3
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 12-18 year olds
- Coming for non-emergent care
- Access to a private computer
- Have email address
Who cannot join
- Not available for follow-up questionnaires
- Unable to read or understand English at a 6th grade reading level
- Medically or emotionally unstable on the day of the visit
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: Integration of Internet-facilitated Screening, Brief Intervention, Referral to Treatment (iSBIRT) for Teen Drug Use Into a Pediatric Network
The Goal of this project is to integrate a previously-tested internet-facilitated Screening, Brief Intervention, and Referral to Treatment (iSBIRT) system for adolescent substance use into a large network of primary care offices, the Pediatric Practices of Children's Hospital Boston (PPOC).
- Conditions
- Substance Use
- Being tested
- iSBIRT
- Keywords
- cannabis abuse, alcohol abuse, substance abuse
- Medical subject headings
- Substance-Related Disorders, Marijuana Abuse, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iSBIRTBehavioural
Participants will be screened for substance use, view information about the health effects of substance use on the computer, and receive advice from the primary care provider regarding the health effects of substance use. Those found to be at "high risk" will complete an internet-based program encouraging them to change their substance use.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | No intervention | Not described |
| iSBIRT | Experimental | Participants will receive the internet-facilitated screening, brief intervention and referral to treatment (iSBIRT intervention) Receives: Behavioral: iSBIRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provider attitude toward iSBIRT
We will evaluate providers' acceptance of and attitude toward integrating iSBIRT into their practices.
Measured: 12 months post baseline
Secondary outcomes (5)
Youth connectedness to provider
We will measure adolescents' attitudes toward their providers' advice regarding the health effects of substance use given during the visit
Measured: Baseline
iSBIRT sustainability
We will measure rates of continued use of iSBIRT by practices 12 months after iSBIRT recruitment and implementation ends
Measured: 12 months post
Change in rates of adolescent substance use
We will measure the change in rates of adolescent substance use from baseline to 3 months post study visit.
Measured: 3 months post baseline
Change in rates of adolescent substance use
We will measure the change in rates of adolescent substance use from baseline to 6 months post study visit.
Measured: 6 months post baseline
Change in rates of adolescent substance use
We will measure the change in rates of adolescent substance use from baseline to 12 months post study visit.
Measured: 12 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2011 (estimated)
- Study startJul 2012
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: The project 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 UseStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- NCT01454206
- Sponsor's protocol ID
- CeASAR app RFADA12008
- Status last verified
- Oct 2016
- First submitted
- 5 Oct 2011
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
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
- Integration of Internet-facilitated Screening, Brief Intervention, Referral to Treatment (iSBIRT) for Teen Drug Use Into a Pediatric Network
- ClinicalTrials.gov ID
- NCT01454206
- Acronym / sponsor ID
- CeASAR app RFADA12008
- Conditions
- Substance Use
- Keywords
- cannabis abuse, alcohol abuse, substance abuse
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The project was not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 18 Oct 2011 (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 this project is to integrate a previously-tested internet-facilitated Screening, Brief Intervention, and Referral to Treatment (iSBIRT) system for adolescent substance use into a large network of primary care offices, the Pediatric Practices of Children's Hospital Boston (PPOC).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | No intervention | – |
| iSBIRT | Experimental | Behavioral: iSBIRTParticipants will receive the internet-facilitated screening, brief intervention and referral to treatment (iSBIRT intervention) |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 12-18 year olds
- Coming for non-emergent care
- Access to a private computer
- Have email address
Key exclusion criteria (3 listed)
- Not available for follow-up questionnaires
- Unable to read or understand English at a 6th grade reading level
- Medically or emotionally unstable on the day of the visit
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 |
|---|---|---|
| iSBIRTParticipants will be screened for substance use, view information about the health effects of substance use on the computer, and receive advice from the primary care provider regarding the health effects of substance use. Those found to be at "high risk" will complete an internet-based program encouraging them to change their substance use. | Behavioural | iSBIRT |
Primary outcome
Provider attitude toward iSBIRT
Time frame: 12 months post baseline
We will evaluate providers' acceptance of and attitude toward integrating iSBIRT into their practices.
5 secondary outcomes
Youth connectedness to provider
Time frame: Baseline
iSBIRT sustainability
Time frame: 12 months post
Change in rates of adolescent substance use
Time frame: 3 months post baseline
Change in rates of adolescent substance use
Time frame: 6 months post baseline
Change in rates of adolescent substance use
Time frame: 12 months post baseline
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.
- Center for Adolescent Substance Abuse Research at Children's Hospital BostonLink provided by the sponsor.
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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.
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 2/3 study testing iSBIRT in people with Substance Use, 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 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: 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Provider attitude toward iSBIRT (time frame: 12 months post baseline). 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.