Substance AbusePhase 3NCT01523444
Advancing Adolescent Screening and Brief Intervention Protocols in Primary Care Settings
A Phase 3 study testing computer-assisted Screening & Brief Advice and computer-assisted Screening & Brief Advice Plus in people with Substance Abuse, run by Treatment Research Institute at 1 site in United States.
Trial summary
This proposed study tests the effectiveness and examines the implementation of screening and brief intervention techniques to delay initiation and reduce substance use among adolescents accessing medical care in Federally Qualified Health Care settings with a computer-facilitated intervention. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse
- What is being tested?
- computer-assisted Screening & Brief Advice and computer-assisted Screening & Brief Advice Plus
- 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 2013to Nov 2017
- Phase
- Phase 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 old patients seeking care at the primary care participating sites
Who cannot join
- Unable to read and understand English
- Medically unstable
- Unavailable for follow-up
Trial locations and contacts
1 site in 1 country.
United States1 site
Treatment Research Institute
Philadelphia, Pennsylvania, 19106
About this study
This proposed study tests the effectiveness and examines the implementation of screening and brief intervention techniques to delay initiation and reduce substance use among adolescents accessing medical care in Federally Qualified Health Care settings with a computer-facilitated intervention. The primary hypothesis is that participants in the intervention groups will be more likely to cease or reduce substance use at follow-up compared to clients in the treatment as usual condition.
Read the detailed description
The aims of the proposed 5-year study are threefold: (1) To examine the effectiveness of a computer-facilitated Screening and Brief Advice (cSBA) to reduce initiation and substance abuse among adolescents in a novel setting; (2) To examine the comparative effectiveness of adding a Brief Intervention and Referral to Treatment component to the cSBA intervention among adolescents in these centers; (3) To examine factors facilitating and inhibiting the implementation of SBIRT-type procedures with adolescents in FQHCs.
- Conditions
- Substance Abuse
- Being tested
- computer-assisted Screening & Brief Advice, computer-assisted Screening & Brief Advice Plus
- Keywords
- Adolescents, Screening, Advice, Referral
- 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.
computer-assisted Screening & Brief AdviceBehavioural
The computer-facilitated screening and brief advice (cSBA) intervention is a self-administered, computer-facilitated screening that asks about lifetime and past-12-month use of substances followed by scientific information about how substance use affects health and true-life stories illustrating the health risks of substance use. The cSBA program prints out a Report Form with the screening results, risk level, and "talking points" designed to prompt a 2 to 3-minute provider/teen conversation about the health effects of substance use, which recommends abstinence.
computer-assisted Screening & Brief Advice PlusBehavioural
The cSBA+ intervention contains cSBA intervention elements plus the delivery of a brief, two-session motivational enhancement therapy (MET) intervention to be delivered a Behavioral Health Counselor (BHC) at the clinic immediately after meeting with the primary care provider. In the first session of this intervention, youth should be encouraged to think about: (1) The role alcohol and drugs play in his/her life; (2) His/her personal goals for changing alcohol and drug use; (3) Strategies for reaching and maintaining goals. The goal at the end of the session is positive movement in the direction of abstinence or change. The aim of the second session is reinforcement of goals set forth in the prior meeting with the BHC.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | No intervention | Not described |
| computer Screening & Brief Advice | Active comparator | All participants receiving care at the site assigned to the computer-facilitated screening and brief advice (cSBA) condition will receive the cSBA intervention as part of their care at that clinic. Receives: Behavioral: computer-assisted Screening & Brief Advice |
| computer Screening & Brief Advice Plus | Experimental | All participants receiving care at the site assigned to the cSBA+ condition will receive the cSBA intervention elements plus the delivery of a brief, two-session motivational enhancement therapy (MET) intervention to be delivered a Behavioral Health Counselor (BHC) at the clinic immediately after meeting with the primary care provider as part of care at that clinic. Receives: Behavioral: computer-assisted Screening & Brief Advice Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced substance use
Measured: 3 and 12 months
Secondary outcomes (1)
Initiation of substance use
Measured: 3 and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startSep 2013
- Primary completionFeb 2016 (estimated)
- Study completionNov 2017 (estimated)
Why it stopped: Study not funded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Treatment Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy Mericle, Ph.D., Principal investigator, Treatment Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523444
- Sponsor's protocol ID
- ASBIRT-PA-11-311
- Status last verified
- Mar 2023
- First submitted
- 27 Jan 2012
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Adolescent Screening and Brief Intervention Protocols in Primary Care Settings
- ClinicalTrials.gov ID
- NCT01523444
- Acronym / sponsor ID
- ASBIRT-PA-11-311
- Conditions
- Substance Abuse
- Keywords
- Adolescents, Screening, Advice, Referral
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not funded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Treatment Research InstituteUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 1 Feb 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.
This proposed study tests the effectiveness and examines the implementation of screening and brief intervention techniques to delay initiation and reduce substance use among adolescents accessing medical care in Federally Qualified Health Care settings with a computer-facilitated intervention. The primary hypothesis is that participants in the intervention groups will be more likely to cease or reduce substance use at follow-up compared to clients in the treatment as usual condition.
Detailed description
The aims of the proposed 5-year study are threefold: (1) To examine the effectiveness of a computer-facilitated Screening and Brief Advice (cSBA) to reduce initiation and substance abuse among adolescents in a novel setting; (2) To examine the comparative effectiveness of adding a Brief Intervention and Referral to Treatment component to the cSBA intervention among adolescents in these centers; (3) To examine factors facilitating and inhibiting the implementation of SBIRT-type procedures with adolescents in FQHCs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | No intervention | – |
| computer Screening & Brief Advice | Active comparator | Behavioral: computer-assisted Screening & Brief AdviceAll participants receiving care at the site assigned to the computer-facilitated screening and brief advice (cSBA) condition will receive the cSBA intervention as part of their care at that clinic. |
| computer Screening & Brief Advice Plus | Experimental | Behavioral: computer-assisted Screening & Brief Advice PlusAll participants receiving care at the site assigned to the cSBA+ condition will receive the cSBA intervention elements plus the delivery of a brief, two-session motivational enhancement therapy (MET) intervention to be delivered a Behavioral Health Counselor (BHC) at the clinic immediately after meeting with the primary care provider as part of care at that clinic. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 12-18 year old patients seeking care at the primary care participating sites
Key exclusion criteria (3 listed)
- Unable to read and understand English
- Medically unstable
- Unavailable for follow-up
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 |
|---|---|---|
| computer-assisted Screening & Brief AdviceThe computer-facilitated screening and brief advice (cSBA) intervention is a self-administered, computer-facilitated screening that asks about lifetime and past-12-month use of substances followed by scientific information about how substance use affects health and true-life stories illustrating the health risks of substance use. The cSBA program prints out a Report Form with the screening results, risk level, and "talking points" designed to prompt a 2 to 3-minute provider/teen conversation about the health effects of substance use, which recommends abstinence. | Behavioural | computer Screening & Brief Advice |
| computer-assisted Screening & Brief Advice PlusThe cSBA+ intervention contains cSBA intervention elements plus the delivery of a brief, two-session motivational enhancement therapy (MET) intervention to be delivered a Behavioral Health Counselor (BHC) at the clinic immediately after meeting with the primary care provider. In the first session of this intervention, youth should be encouraged to think about: (1) The role alcohol and drugs play in his/her life; (2) His/her personal goals for changing alcohol and drug use; (3) Strategies for reaching and maintaining goals. The goal at the end of the session is positive movement in the direction of abstinence or change. The aim of the second session is reinforcement of goals set forth in the prior meeting with the BHC. | Behavioural | computer Screening & Brief Advice Plus |
Primary outcome
Reduced substance use
Time frame: 3 and 12 months
1 secondary outcome
Initiation of substance use
Time frame: 3 and 12 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 28 Mar 2023.
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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.
Amy Mericle, Ph.D. principal investigator
Treatment 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 3 study testing computer-assisted Screening & Brief Advice and computer-assisted Screening & Brief Advice Plus in people with Substance Abuse, run by Treatment 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 1 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 28 Mar 2023. 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 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?
Reduced substance use (time frame: 3 and 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 28 Mar 2023.