Trial of Automated Risk Appraisal for Adolescents

Depression Clinical Trial

— TARAA  

Official title:

Trial of Automated Risk Appraisal for Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00505440
• Other study ID #: 5R01DA018943-04
• Secondary ID: R01DA018943
• Status: Completed
• Phase: N/A
• First received: July 19, 2007
• Last updated: April 22, 2013
• Start date: June 2005
• Est. completion date: June 2008

Study information

• Verified date: April 2013
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1185
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 20 Years

Eligibility

Inclusion Criteria:

• 11-20 years of age

• non-emergent visit in primary care office

• consent and assent (if applicable)

Exclusion Criteria:

• non-english speaking

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Depression
• Risk Behavior
• Substance Use
• Suicidal Ideation

Intervention

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
• Usual care
Usual care with mailed screening results

Locations

Country	Name	City	State
United States	Columbus Children's Research Institute	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Nationwide Children's Hospital	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. Epub 2007 Feb 6. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		6 months	No
Secondary	receipt of counseling services		6 months	No
Secondary	referral to mental health and other services		6 months	No
Secondary	medications for mental health disorders		6 months	No
Secondary	return to primary care		6 months	No
Secondary	completion of referrals		6 months	No
Secondary	number of primary care visits		6 months	No
Secondary	number of specialty visits		6 months	No
Secondary	satisfaction with RA/TS services		4 months	No