Trial of Automated Risk Appraisal for Adolescents (TARAA)
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|ClinicalTrials.gov Identifier: NCT00505440|
Recruitment Status : Completed
First Posted : July 23, 2007
Last Update Posted : April 23, 2013
|Condition or disease||Intervention/treatment||Phase|
|Substance Use Depression Suicidal Ideation Risk Behavior||Behavioral: Telephone case management and motivational interviewing Behavioral: Usual care||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1185 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Trial of Automated Risk Appraisal for Adolescents|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
Experimental: Computerized screening and referral
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.
Behavioral: 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
Active Comparator: Delayed feedback from screening
Active comparator is Usual pediatric care plus mailed screening results from computerized waiting room screens that arrive three days after screening.
Behavioral: Usual care
Usual care with mailed screening results
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00505440
|United States, Ohio|
|Columbus Children's Research Institute|
|Columbus, Ohio, United States, 43205|
|Principal Investigator:||Kelly Kelleher, MD, MPH||Nationwide Children's Hospital|