Substance-related DisordersNCT00593034
Medical Office Intervention for Adolescent Drug Use - Attention Study Supplement
An observational study of Substance-related Disorders, run by Boston Children's Hospital at 1 site in United States.
Trial summary
This study will use the CCPT II to assess attention in 12-21 year olds enrolled in a randomized controlled trial of a brief behavioral treatment for substance abuse. This study will describe at baseline levels of attention using a well validated instrument (Connors Continuous Performance Test II) and explore the… Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Substance-related Disorders
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Feb 2008
- Phase
- Observational
- 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
Study population: Participants in this study will be 12-21 year old patients who have been referred to the Adolescent Substance Abuse Program for evaluation of drug or alcohol use and are participating in the parent study, "Medical Office Intervention for Adolescent Drug Abuse."
Who may be able to join
- CRAFFT score of 1 or more
- Have used cannabis, alcohol or another drug on at least two occasions during the 30 days preceding their visit
- Can read and understand English
Who cannot join
- Require immediate hospitalization or referral to residential substance abuse treatment
- Will not be available to complete the study assessments over the next 9 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: Medical Office Intervention for Adolescent Drug Use - Research Supplement for Under-represented Minorities
This study will use the CCPT II to assess attention in 12-21 year olds enrolled in a randomized controlled trial of a brief behavioral treatment for substance abuse.
This study will describe at baseline levels of attention using a well validated instrument (Connors Continuous Performance Test II) and explore the association between attention levels and substance use. The primary study hypothesis is that lower initial levels of substance use (as measured by percent days abstinent) will be associated with higher attention levels. We envision that this data will inform a better understanding of how attention may modify treatment response.
Read the detailed description
Research among adolescents with substance use problems presents unique challenges to investigators. Issues with recruitment, confidentiality, and follow-up have been cited as common limitations to research in this area. One likely contributor to decreased treatment persistence and follow-up is the limited ability to sustain attention that many adolescents, especially those with substance problems, may manifest. (Taper, 2002) Thus, assessing attention before beginning substance abuse treatment has the potential not only to inform the science of adolescent addiction medicine, but also to guide the development of therapies to specifically address attention deficits among adolescent substance users. Adolescent outpatients being treated for substance problems have not been systematically studied for clinical or subclinical attention levels.
The primary aims this study are as follows:
- To test the feasibility of administering the Connors Continuous Performance Test II (CCPT II), a well validated measure of attention, to a sample of 12-21 year old patients receiving treatment for substance abuse.
- To obtain baseline descriptive statistics on the CCPT II in a previously understudied group of young patients receiving treatment for substance abuse.
- To estimate the magnitude of the association between substance use and levels of attention at baseline before treatment.
- To explore the degree to which attention may affect response to substance abuse treatment in general and specifically motivational interviewing.
- Conditions
- Substance-related Disorders
- Keywords
- Alcohol abuse, Drug abuse
- Medical subject headings
- Substance-Related Disorders, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Participants in this study will be 12-21 year old patients who have been referred to the Adolescent Substance Abuse Program for evaluation of drug or alcohol use and are participating in the parent study, "Medical Office Intervention for Adolescent Drug Abuse." |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on the Connors Continuous Performance Test II (CCPT II)
Measured: Baseline
Secondary outcomes (1)
Percentage of days abstinent
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startFeb 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- John R Knight, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593034
- Sponsor's protocol ID
- R01DA014553-03S1
- Status last verified
- Mar 2011
- First submitted
- 3 Jan 2008
- Last updated
- 8 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Knight JR, Shrier LA, Bravender TD, Farrell M, Vander Bilt J, Shaffer HJ. A new brief screen for adolescent substance abuse. Arch Pediatr Adolesc Med. 1999 Jun;153(6):591-6. doi: 10.1001/archpedi.153.6.591.
PubMed 10357299Knight JR, Sherritt L, Shrier LA, Harris SK, Chang G. Validity of the CRAFFT substance abuse screening test among adolescent clinic patients. Arch Pediatr Adolesc Med. 2002 Jun;156(6):607-14. doi: 10.1001/archpedi.156.6.607.
PubMed 12038895
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Office Intervention for Adolescent Drug Use - Research Supplement for Under-represented Minorities
- ClinicalTrials.gov ID
- NCT00593034
- Acronym / sponsor ID
- R01DA014553-03S1
- Conditions
- Substance-related Disorders
- Keywords
- Alcohol abuse, Drug abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 14 Jan 2008 (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 study will use the CCPT II to assess attention in 12-21 year olds enrolled in a randomized controlled trial of a brief behavioral treatment for substance abuse.
This study will describe at baseline levels of attention using a well validated instrument (Connors Continuous Performance Test II) and explore the association between attention levels and substance use. The primary study hypothesis is that lower initial levels of substance use (as measured by percent days abstinent) will be associated with higher attention levels. We envision that this data will inform a better understanding of how attention may modify treatment response.
Detailed description
Research among adolescents with substance use problems presents unique challenges to investigators. Issues with recruitment, confidentiality, and follow-up have been cited as common limitations to research in this area. One likely contributor to decreased treatment persistence and follow-up is the limited ability to sustain attention that many adolescents, especially those with substance problems, may manifest. (Taper, 2002) Thus, assessing attention before beginning substance abuse treatment has the potential not only to inform the science of adolescent addiction medicine, but also to guide the development of therapies to specifically address attention deficits among adolescent substance users. Adolescent outpatients being treated for substance problems have not been systematically studied for clinical or subclinical attention levels.
The primary aims this study are as follows:
- To test the feasibility of administering the Connors Continuous Performance Test II (CCPT II), a well validated measure of attention, to a sample of 12-21 year old patients receiving treatment for substance abuse.
- To obtain baseline descriptive statistics on the CCPT II in a previously understudied group of young patients receiving treatment for substance abuse.
- To estimate the magnitude of the association between substance use and levels of attention at baseline before treatment.
- To explore the degree to which attention may affect response to substance abuse treatment in general and specifically motivational interviewing.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Participants in this study will be 12-21 year old patients who have been referred to the Adolescent Substance Abuse Program for evaluation of drug or alcohol use and are participating in the parent study, "Medical Office Intervention for Adolescent Drug Abuse." |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants in this study will be 12-21 year old patients who have been referred to the Adolescent Substance Abuse Program for evaluation of drug or alcohol use and are participating in the parent study, "Medical Office Intervention for Adolescent Drug Abuse."
Key inclusion criteria (3 listed)
- CRAFFT score of 1 or more
- Have used cannabis, alcohol or another drug on at least two occasions during the 30 days preceding their visit
- Can read and understand English
Key exclusion criteria (2 listed)
- Require immediate hospitalization or referral to residential substance abuse treatment
- Will not be available to complete the study assessments over the next 9 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Score on the Connors Continuous Performance Test II (CCPT II)
Time frame: Baseline
1 secondary outcome
Percentage of days abstinent
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2011.
- Background: PubMed 10357299Knight JR, Shrier LA, Bravender TD, Farrell M, Vander Bilt J, Shaffer HJ. A new brief screen for adolescent substance abuse. Arch Pediatr Adolesc Med. 1999 Jun;153(6):591-6. doi: 10.1001/archpedi.153.6.591.
- Background: PubMed 12038895Knight JR, Sherritt L, Shrier LA, Harris SK, Chang G. Validity of the CRAFFT substance abuse screening test among adolescent clinic patients. Arch Pediatr Adolesc Med. 2002 Jun;156(6):607-14. doi: 10.1001/archpedi.156.6.607.
- Web site for the Center for Adolescent Substance Abuse Research, parent research group for the project.Link 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?
An observational study of Substance-related Disorders, 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: finished, as of the sponsor's last update on 8 Mar 2011. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Score on the Connors Continuous Performance Test II (CCPT II) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00593034, which also lists 2 linked publications.
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 8 Mar 2011.