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OpenTrials
Completed

NCT Number: NCT00505440

Trial of Automated Risk Appraisal for Adolescents

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.

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Key information

Age range

11 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbus Children's Research Institute

Columbus, Ohio, 43205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 11-20 years of age
  • non-emergent visit in primary care office
  • consent and assent (if applicable)

Exclusion criteria

  • non-english speaking

Treatment and study plan

Telephone case management and motivational interviewing

Behavioral

'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 Care

Behavioral

Usual care with mailed screening results

Primary outcomes

  1. 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 outcomes

  1. receipt of counseling services

    Time frame: 6 months

  2. referral to mental health and other services

    Time frame: 6 months

  3. medications for mental health disorders

    Time frame: 6 months

  4. return to primary care

    Time frame: 6 months

  5. completion of referrals

    Time frame: 6 months

  6. number of primary care visits

    Time frame: 6 months

  7. number of specialty visits

    Time frame: 6 months

  8. satisfaction with RA/TS services

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: TARAA

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jul 23, 2007
Registry last updated
Apr 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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