Trial of Automated Risk Appraisal for Adolescents (TARAA)
Primary Purpose
Substance Use, Depression, Suicidal Ideation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone case management and motivational interviewing
Usual care
Sponsored by
About this trial
This is an interventional screening trial for Substance Use
Eligibility Criteria
Inclusion Criteria:
- 11-20 years of age
- non-emergent visit in primary care office
- consent and assent (if applicable)
Exclusion Criteria:
- non-english speaking
Sites / Locations
- Columbus Children's Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Computerized screening and referral
Delayed feedback from screening
Arm Description
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.
Active comparator is Usual pediatric care plus mailed screening results from computerized waiting room screens that arrive three days after screening.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
receipt of counseling services
referral to mental health and other services
medications for mental health disorders
return to primary care
completion of referrals
number of primary care visits
number of specialty visits
satisfaction with RA/TS services
Full Information
NCT ID
NCT00505440
First Posted
July 19, 2007
Last Updated
April 22, 2013
Sponsor
Nationwide Children's Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00505440
Brief Title
Trial of Automated Risk Appraisal for Adolescents
Acronym
TARAA
Official Title
Trial of Automated Risk Appraisal for Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Depression, Suicidal Ideation, Risk Behavior
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
1185 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Computerized screening and referral
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed feedback from screening
Arm Type
Active Comparator
Arm Description
Active comparator is Usual pediatric care plus mailed screening results from computerized waiting room screens that arrive three days after screening.
Intervention Type
Behavioral
Intervention Name(s)
Telephone case management and motivational interviewing
Intervention Description
'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
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Usual care with mailed screening results
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
receipt of counseling services
Time Frame
6 months
Title
referral to mental health and other services
Time Frame
6 months
Title
medications for mental health disorders
Time Frame
6 months
Title
return to primary care
Time Frame
6 months
Title
completion of referrals
Time Frame
6 months
Title
number of primary care visits
Time Frame
6 months
Title
number of specialty visits
Time Frame
6 months
Title
satisfaction with RA/TS services
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
11-20 years of age
non-emergent visit in primary care office
consent and assent (if applicable)
Exclusion Criteria:
non-english speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly Kelleher, MD, MPH
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbus Children's Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17472829
Citation
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.
Results Reference
background
PubMed Identifier
17279327
Citation
Julian 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.
Results Reference
background
PubMed Identifier
16775519
Citation
Kaizar 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.
Results Reference
background
PubMed Identifier
15132755
Citation
Gardner 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.
Results Reference
background
PubMed Identifier
12218771
Citation
Gardner 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.
Results Reference
background
PubMed Identifier
16471390
Citation
Chisolm 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.
Results Reference
background
PubMed Identifier
18519478
Citation
Stevens 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.
Results Reference
derived
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Trial of Automated Risk Appraisal for Adolescents
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