Substance UseTARAANCT00505440
Trial of Automated Risk Appraisal for Adolescents
A study testing Telephone case management and motivational interviewing in people with Substance Use and Depression, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
This is a study to find out which type of computer screening and nursing support can improve screening for high risk behaviors in doctor's offices. Recommendations call for doctors to screen young people for many different behaviors and feelings such as depression, not wearing seat belts, alcohol and drug use. Read more about this study
- Who is it for?
- Ages 11 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use, Depression, Suicidal Ideation
- What is being tested?
- Telephone case management and motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,185 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jun 2008
- 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 11 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 11-20 years of age
- non-emergent visit in primary care office
- consent and assent (if applicable)
Who cannot join
- non-english speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbus Children's Research Institute
Columbus, Ohio, 43205
About this study
This is a study to find out which type of computer screening and nursing support can improve screening for high risk behaviors in doctor's offices. Recommendations call for doctors to screen young people for many different behaviors and feelings such as depression, not wearing seat belts, alcohol and drug use. Doctors rarely have time to complete these screenings. New computers can help ask some of these questions and protect patient information. In addition, nurse telephone calls can often help young persons with some of the behaviors receive treatment. This study will examine which type of computer screening and follow-up will help patients the most.
Read the detailed description
The pandemic of problem drug use and abuse and related health problems among young persons aged 12-25 in the U.S. continues unabated, in part, because opportunities for early identification and monitoring are missed. In particular, improved recognition of, and ongoing contact for, problem drug use and abuse among pre-teens and early adolescents in primary care settings could provide important information to health care professionals and engage early intervention services. Unfortunately, many barriers exist to routine screening and monitoring in primary care settings. These include the expense of traditional paper and pencil screening, competing demands on primary care clinicians and office staff, complex scoring programs and the ability to track youth over time.
Innovative information technology and support services can overcome many of these barriers. New primary care information systems allow for direct data entry by youth in healthcare settings, automated scoring and printing, decreased staff time, individual or practice level results and patient follow-up for intervention services. However, these assessment tools and systems have not been adequately assessed for their roles in detecting problem drug use and abuse in youth, and appropriate follow-up and tracking systems for those identified have not been implemented.
Our goal is to improve services for problem drug use and abuse and other related health risking behaviors for youth in primary care settings through early identification and monitoring. We expand an innovative partnership among the Columbus Children's Hospital, the Close To Home Primary Care Centers and Flipsidemedia.com to test the efficacy and acceptability of an early identification and monitoring system for problem drug use and abuse, depression and related mental disorders among pre-teens and teenagers in a randomized trial. We propose to compare care in nine Close To Home Centers with Automated Risk Appraisal for Adolescents/Telephone Support (RA/TS) compared to usual care plus mailed screening results (UC+). Each site will be randomly assigned to start with six months on RA/TS or six months on UC+ and follow with the alternative in a crossover design. RA/TS is a web-based screening and assessment tool completed by adolescents during primary care visits and a linked, structured telephone tracking intervention consisting of three follow-up telephone calls to youth and their families monitoring identified problems and barriers to services. Specifically, we aim to:
- compare frequency of problem drug use and abuse identification in RA/TS youth vs. youth in usual care (UC+);
- examine frequency of counseling, referral, psychotropic medication or other interventions for youth screening positive for problem drug use and abuse on RA (Risk Appraisal) in RA/TS youth vs. UC+ youth; and
- evaluate the effects of the TS (Telephone Support) program on return to primary care, likelihood of completing referrals, number of primary care visits, number of specialty visits, and satisfaction with services after four months for youth screening positive for problem drug use and abuse.
- Conditions
- Substance Use, Depression, Suicidal Ideation, Risk Behavior
- Being tested
- Telephone case management and motivational interviewing, Usual care
- Medical subject headings
- Substance-Related Disorders, Depression, Suicidal Ideation, Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone case management and motivational interviewingBehavioural
'Telephone case management and motivational interviewing': Immediate screening results are given to the physician during the patient's visit. Telephone case management and motivational interviewing (MI) at 1, 6, and 9 weeks to enhance engagement and commitment to change
Usual careBehavioural
Usual care with mailed screening results
| Study group | Role | What they receive |
|---|---|---|
| Computerized screening and referral | Experimental | Computerized screening and referral: Intervention is a web-based screening and assessment tool completed by adolescents during primary care visits. Patient reported screening provided to primary care physicians in real time with recommendations for behavioral referrals. Receives: Behavioral: Telephone case management and motivational interviewing |
| Delayed feedback from screening | Active comparator | Active comparator is Usual pediatric care plus mailed screening results from computerized waiting room screens that arrive three days after screening. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
identification of problem drug use and abuse, depression, and other mental disorders using the Automated Risk Appraisal for Adolescents / Telephone Support (RA/TS) tool compared with usual care practices
Measured: 6 months
Secondary outcomes (8)
receipt of counseling services
Measured: 6 months
referral to mental health and other services
Measured: 6 months
medications for mental health disorders
Measured: 6 months
return to primary care
Measured: 6 months
completion of referrals
Measured: 6 months
number of primary care visits
Measured: 6 months
number of specialty visits
Measured: 6 months
satisfaction with RA/TS services
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2007 (estimated)
- Study startJun 2005
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by Nationwide 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Kelly Kelleher, Nationwide Children's Hospital
- Investigators
- Kelly Kelleher, MD, MPH, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505440
- Sponsor's protocol ID
- 5R01DA018943-04
- Other IDs
- R01DA018943
- Acronym
- TARAA
- Status last verified
- Apr 2013
- First submitted
- 19 Jul 2007
- Last updated
- 23 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Penfold RB, Kelleher KJ. Use of surveillance data in developing geographic dissemination strategies: a study of the diffusion of olanzapine to Michigan children insured by medicaid. Clin Ther. 2007 Feb;29(2):359-70; discussion 358. doi: 10.1016/j.clinthera.2007.02.017.
PubMed 17472829Julian TW, Kelleher K, Julian DA, Chisolm D. Using technology to enhance prevention services for children in primary care. J Prim Prev. 2007 Mar;28(2):155-65. doi: 10.1007/s10935-007-0086-8. Epub 2007 Feb 6.
PubMed 17279327Kaizar E, Chisolm D, Seltman H, Greenhouse J, Kelleher KJ. The role of care location in diagnosis and treatment of pediatric psychosocial conditions. J Dev Behav Pediatr. 2006 Jun;27(3):219-25. doi: 10.1097/00004703-200606000-00007.
PubMed 16775519Gardner W, Shear K, Kelleher KJ, Pajer KA, Mammen O, Buysse D, Frank E. Computerized adaptive measurement of depression: a simulation study. BMC Psychiatry. 2004 May 6;4:13. doi: 10.1186/1471-244X-4-13.
PubMed 15132755Gardner W, Kelleher KJ, Pajer KA. Multidimensional adaptive testing for mental health problems in primary care. Med Care. 2002 Sep;40(9):812-23. doi: 10.1097/00005650-200209000-00010.
PubMed 12218771Chisolm DJ, Young RR, McAlearney AS. Implementation of a touch-screen new patient registration system: a case study. J Med Pract Manage. 2005 Nov-Dec;21(3):159-62.
PubMed 16471390Stevens J, Kelleher KJ, Gardner W, Chisolm D, McGeehan J, Pajer K, Buchanan L. Trial of computerized screening for adolescent behavioral concerns. Pediatrics. 2008 Jun;121(6):1099-105. doi: 10.1542/peds.2007-1878.
PubMed 18519478
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Automated Risk Appraisal for Adolescents
- ClinicalTrials.gov ID
- NCT00505440
- Acronym / sponsor ID
- TARAA / 5R01DA018943-04
- Conditions
- Substance Use, Depression, Suicidal Ideation, Risk Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,185 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 23 Jul 2007 (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 is a study to find out which type of computer screening and nursing support can improve screening for high risk behaviors in doctor's offices. Recommendations call for doctors to screen young people for many different behaviors and feelings such as depression, not wearing seat belts, alcohol and drug use. Doctors rarely have time to complete these screenings. New computers can help ask some of these questions and protect patient information. In addition, nurse telephone calls can often help young persons with some of the behaviors receive treatment. This study will examine which type of computer screening and follow-up will help patients the most.
Detailed description
The pandemic of problem drug use and abuse and related health problems among young persons aged 12-25 in the U.S. continues unabated, in part, because opportunities for early identification and monitoring are missed. In particular, improved recognition of, and ongoing contact for, problem drug use and abuse among pre-teens and early adolescents in primary care settings could provide important information to health care professionals and engage early intervention services. Unfortunately, many barriers exist to routine screening and monitoring in primary care settings. These include the expense of traditional paper and pencil screening, competing demands on primary care clinicians and office staff, complex scoring programs and the ability to track youth over time.
Innovative information technology and support services can overcome many of these barriers. New primary care information systems allow for direct data entry by youth in healthcare settings, automated scoring and printing, decreased staff time, individual or practice level results and patient follow-up for intervention services. However, these assessment tools and systems have not been adequately assessed for their roles in detecting problem drug use and abuse in youth, and appropriate follow-up and tracking systems for those identified have not been implemented.
Our goal is to improve services for problem drug use and abuse and other related health risking behaviors for youth in primary care settings through early identification and monitoring. We expand an innovative partnership among the Columbus Children's Hospital, the Close To Home Primary Care Centers and Flipsidemedia.com to test the efficacy and acceptability of an early identification and monitoring system for problem drug use and abuse, depression and related mental disorders among pre-teens and teenagers in a randomized trial. We propose to compare care in nine Close To Home Centers with Automated Risk Appraisal for Adolescents/Telephone Support (RA/TS) compared to usual care plus mailed screening results (UC+). Each site will be randomly assigned to start with six months on RA/TS or six months on UC+ and follow with the alternative in a crossover design. RA/TS is a web-based screening and assessment tool completed by adolescents during primary care visits and a linked, structured telephone tracking intervention consisting of three follow-up telephone calls to youth and their families monitoring identified problems and barriers to services. Specifically, we aim to:
- compare frequency of problem drug use and abuse identification in RA/TS youth vs. youth in usual care (UC+);
- examine frequency of counseling, referral, psychotropic medication or other interventions for youth screening positive for problem drug use and abuse on RA (Risk Appraisal) in RA/TS youth vs. UC+ youth; and
- evaluate the effects of the TS (Telephone Support) program on return to primary care, likelihood of completing referrals, number of primary care visits, number of specialty visits, and satisfaction with services after four months for youth screening positive for problem drug use and abuse.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computerized screening and referral | Experimental | Behavioral: Telephone case management and motivational interviewingComputerized screening and referral: Intervention is a web-based screening and assessment tool completed by adolescents during primary care visits. Patient reported screening provided to primary care physicians in real time with recommendations for behavioral referrals. |
| Delayed feedback from screening | Active comparator | Behavioral: Usual careActive comparator is Usual pediatric care plus mailed screening results from computerized waiting room screens that arrive three days after screening. |
Who may qualify
- Ages
- 11 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 11-20 years of age
- non-emergent visit in primary care office
- consent and assent (if applicable)
Key exclusion criteria (1 listed)
- non-english speaking
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 |
|---|---|---|
| Telephone case management and motivational interviewing'Telephone case management and motivational interviewing': Immediate screening results are given to the physician during the patient's visit. Telephone case management and motivational interviewing (MI) at 1, 6, and 9 weeks to enhance engagement and commitment to change | Behavioural | Computerized screening and referral |
| Usual careUsual care with mailed screening results | Behavioural | Delayed feedback from screening |
Primary outcome
identification of problem drug use and abuse, depression, and other mental disorders using the Automated Risk Appraisal for Adolescents / Telephone Support (RA/TS) tool compared with usual care practices
Time frame: 6 months
8 secondary outcomes
receipt of counseling services
Time frame: 6 months
referral to mental health and other services
Time frame: 6 months
medications for mental health disorders
Time frame: 6 months
return to primary care
Time frame: 6 months
completion of referrals
Time frame: 6 months
number of primary care visits
Time frame: 6 months
number of specialty visits
Time frame: 6 months
satisfaction with RA/TS services
Time frame: 4 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 23 Apr 2013.
- Background: PubMed 17472829Penfold RB, Kelleher KJ. Use of surveillance data in developing geographic dissemination strategies: a study of the diffusion of olanzapine to Michigan children insured by medicaid. Clin Ther. 2007 Feb;29(2):359-70; discussion 358. doi: 10.1016/j.clinthera.2007.02.017.
- Background: PubMed 17279327Julian TW, Kelleher K, Julian DA, Chisolm D. Using technology to enhance prevention services for children in primary care. J Prim Prev. 2007 Mar;28(2):155-65. doi: 10.1007/s10935-007-0086-8. Epub 2007 Feb 6.
- Background: PubMed 16775519Kaizar E, Chisolm D, Seltman H, Greenhouse J, Kelleher KJ. The role of care location in diagnosis and treatment of pediatric psychosocial conditions. J Dev Behav Pediatr. 2006 Jun;27(3):219-25. doi: 10.1097/00004703-200606000-00007.
- Background: PubMed 15132755Gardner W, Shear K, Kelleher KJ, Pajer KA, Mammen O, Buysse D, Frank E. Computerized adaptive measurement of depression: a simulation study. BMC Psychiatry. 2004 May 6;4:13. doi: 10.1186/1471-244X-4-13.
- Background: PubMed 12218771Gardner W, Kelleher KJ, Pajer KA. Multidimensional adaptive testing for mental health problems in primary care. Med Care. 2002 Sep;40(9):812-23. doi: 10.1097/00005650-200209000-00010.
- Background: PubMed 16471390Chisolm DJ, Young RR, McAlearney AS. Implementation of a touch-screen new patient registration system: a case study. J Med Pract Manage. 2005 Nov-Dec;21(3):159-62.
- Derived from this study: PubMed 18519478Stevens J, Kelleher KJ, Gardner W, Chisolm D, McGeehan J, Pajer K, Buchanan L. Trial of computerized screening for adolescent behavioral concerns. Pediatrics. 2008 Jun;121(6):1099-105. doi: 10.1542/peds.2007-1878.
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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.
Kelly Kelleher, MD, MPH principal investigator
Nationwide 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 Telephone case management and motivational interviewing in people with Substance Use and Depression, run by Nationwide 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 1 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 23 Apr 2013. 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?
identification of problem drug use and abuse, depression, and other mental disorders using the Automated Risk Appraisal for Adolescents / Telephone Support (RA/TS) tool compared with usual care practices (time frame: 6 months). 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 NCT00505440, which also lists 7 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 23 Apr 2013.