Trial of Automated Risk Appraisal for Adolescents (TARAA)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kelly Kelleher, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT00505440
First received: July 19, 2007
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Substance Use
Depression
Suicidal Ideation
Risk Behavior
Behavioral: Telephone case management and motivational interviewing
Behavioral: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Trial of Automated Risk Appraisal for Adolescents

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • receipt of counseling services [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • referral to mental health and other services [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • medications for mental health disorders [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • return to primary care [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • completion of referrals [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • number of primary care visits [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • number of specialty visits [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • satisfaction with RA/TS services [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 1185
Study Start Date: June 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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:

  1. compare frequency of problem drug use and abuse identification in RA/TS youth vs. youth in usual care (UC+);
  2. 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
  3. 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.
  Eligibility

Ages Eligible for Study:   11 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505440

Locations
United States, Ohio
Columbus Children's Research Institute
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Kelly Kelleher, MD, MPH Nationwide Children's Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kelly Kelleher, Professor of Pediatrics, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT00505440     History of Changes
Other Study ID Numbers: 5R01DA018943-04, R01DA018943
Study First Received: July 19, 2007
Last Updated: April 22, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Depression
Depressive Disorder
Suicidal Ideation
Behavioral Symptoms
Mood Disorders
Mental Disorders
Suicide
Self-Injurious Behavior

ClinicalTrials.gov processed this record on August 21, 2014