Alcohol AbuseNCT01709201
Reducing Problematic Substance Use in Youth With Chronic Medical Conditions
A study testing Brief Intervention in people with Alcohol Abuse and Drug Abuse, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The investigators goal is to pilot a substance use-related brief intervention (BI) for youth with chronic medical conditions, obtaining preliminary evidence of feasibility, acceptability and impacts of the approach for reducing substance use among this group. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Alcohol Abuse, Drug Abuse
- What is being tested?
- Brief Intervention
- 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 2013to Jun 2015
- Phase
- Interventional
- 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 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 14-18 years old
- Currently being treated for diabetes, rheumatologic disorders, asthma, or ulcerative colitis (UC) at Boston Children's Hospital with a duration of chronic illness of at least one year
- Previous participation in the screening validation study
- Evidence of problems related to substance use
Who cannot join
- Medically or emotionally unstable or otherwise unable to provide assent/consent
- Unable to speak/read English
- Unable to use a computer keyboard and/or complete an interviewer-assisted questionnaire
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
The investigators goal is to pilot a substance use-related brief intervention (BI) for youth with chronic medical conditions, obtaining preliminary evidence of feasibility, acceptability and impacts of the approach for reducing substance use among this group.
- Conditions
- Alcohol Abuse, Drug Abuse
- Being tested
- Brief Intervention
- Keywords
- Alcohol abuse, Drug abuse, Diabetes Mellitus, Persistent Asthma, Juvenile Arthritis, Ulcerative Colitis
- Medical subject headings
- Alcoholism, Substance-Related Disorders, Diabetes Mellitus, Arthritis, Juvenile, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief InterventionBehavioural
Those in the intervention arm will undergo a 10-minute discussion with a trained interventionist aimed at encouraging decreased substance use.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | No intervention | Those in the Treatment as Usual group will not receive the brief intervention for substance use but will receive a brief health education brochure. |
| Brief Intervention | Experimental | Those in the Brief Intervention group will receive a brief motivational intervention aimed at encouraging the participant to decrease their substance use. Receives: Behavioral: Brief Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent days abstinent
We will compare the percent days abstinent from substances between the Treatment as Usual and Intervention groups 30 days post baseline
Measured: 30 days post baseline
Secondary outcomes (1)
Medical complications
We will evaluate the incidents of disease complications between the Treatment as Usual and Intervention groups 30 days post baseline
Measured: 30 days 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 2012 (estimated)
- Study startJul 2013
- Primary completionDec 2014 (estimated)
- Study completionJun 2015 (estimated)
Why it stopped: Study did not receive funding and was administratively withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-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, Sharon Levy, Boston Children's Hospital
- Investigators
- Sharon Levy, MD, MPH, Principal investigator, Boston Children's HospitalElissa Weitzman, ScD, MSc, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709201
- Sponsor's protocol ID
- FP01009751
- Status last verified
- Jun 2017
- First submitted
- 15 Oct 2012
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Problematic Substance Use in Youth With Chronic Medical Conditions
- ClinicalTrials.gov ID
- NCT01709201
- Acronym / sponsor ID
- FP01009751
- Conditions
- Alcohol Abuse, Drug Abuse
- Keywords
- Alcohol abuse, Drug abuse, Diabetes Mellitus, Persistent Asthma, Juvenile Arthritis, Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study did not receive funding and was administratively withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 18 Oct 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 investigators goal is to pilot a substance use-related brief intervention (BI) for youth with chronic medical conditions, obtaining preliminary evidence of feasibility, acceptability and impacts of the approach for reducing substance use among this group.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | No intervention | –Those in the Treatment as Usual group will not receive the brief intervention for substance use but will receive a brief health education brochure. |
| Brief Intervention | Experimental | Behavioral: Brief InterventionThose in the Brief Intervention group will receive a brief motivational intervention aimed at encouraging the participant to decrease their substance use. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 14-18 years old
- Currently being treated for diabetes, rheumatologic disorders, asthma, or ulcerative colitis (UC) at Boston Children's Hospital with a duration of chronic illness of at least one year
- Previous participation in the screening validation study
- Evidence of problems related to substance use
Key exclusion criteria (3 listed)
- Medically or emotionally unstable or otherwise unable to provide assent/consent
- Unable to speak/read English
- Unable to use a computer keyboard and/or complete an interviewer-assisted questionnaire
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 |
|---|---|---|
| Brief InterventionThose in the intervention arm will undergo a 10-minute discussion with a trained interventionist aimed at encouraging decreased substance use. | Behavioural | Brief Intervention |
Primary outcome
Percent days abstinent
Time frame: 30 days post baseline
We will compare the percent days abstinent from substances between the Treatment as Usual and Intervention groups 30 days post baseline
1 secondary outcome
Medical complications
Time frame: 30 days 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 21 Jun 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.
Sharon Levy, MD, MPH principal investigator
Boston Children's Hospital
Elissa Weitzman, ScD, MSc 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 study testing Brief Intervention in people with Alcohol Abuse and Drug 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 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 21 Jun 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.
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?
Percent days abstinent (time frame: 30 days 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 21 Jun 2017.