NCT00505440

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,185

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

April 23, 2013

Status Verified

April 1, 2013

Enrollment Period

3 years

First QC Date

July 19, 2007

Last Update Submit

April 22, 2013

Conditions

Outcome Measures

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

    6 months

Secondary Outcomes (8)

  • receipt of counseling services

    6 months

  • referral to mental health and other services

    6 months

  • medications for mental health disorders

    6 months

  • return to primary care

    6 months

  • completion of referrals

    6 months

  • +3 more secondary outcomes

Study Arms (2)

Computerized screening and referral

EXPERIMENTAL

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

Delayed feedback from screening

ACTIVE COMPARATOR

Active comparator is Usual pediatric care plus mailed screening results from computerized waiting room screens that arrive three days after screening.

Behavioral: Usual care

Interventions

'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

Computerized screening and referral
Usual careBEHAVIORAL

Usual care with mailed screening results

Delayed feedback from screening

Eligibility Criteria

Age11 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • non-english speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbus Children's Research Institute

Columbus, Ohio, 43205, United States

Location

Related Publications (7)

  • 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.

    PMID: 17472829BACKGROUND
  • 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.

    PMID: 17279327BACKGROUND
  • 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.

    PMID: 16775519BACKGROUND
  • 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.

    PMID: 15132755BACKGROUND
  • 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.

    PMID: 12218771BACKGROUND
  • 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.

    PMID: 16471390BACKGROUND
  • 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.

MeSH Terms

Conditions

Substance-Related DisordersDepressionSuicidal IdeationRisk-Taking

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersBehavioral SymptomsBehaviorSuicideSelf-Injurious Behavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Kelly Kelleher, MD, MPH

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

July 19, 2007

First Posted

July 23, 2007

Study Start

June 1, 2005

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

April 23, 2013

Record last verified: 2013-04

Locations