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Detecting and Evaluating Childhood and Anxiety and Depression Effectively in Subspecialties (DECADES)

This study is not yet open for participant recruitment.
Verified May 2016 by William E. Bennett, Jr., Indiana University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02773706
First Posted: May 16, 2016
Last Update Posted: May 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
William E. Bennett, Jr., Indiana University
  Purpose
The DECADES trial seeks to determine the comparative effectiveness of specialist-centered management of anxiety and depression vs. an imbedded and automated psychology referral for all subjects who screen positive for anxiety or depression.

Condition Intervention
Anxiety Depression Other: Automated Psychology Services Other: Notification of Subspecialist

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Detecting and Evaluating Childhood and Anxiety and Depression Effectively in Subspecialties

Resource links provided by NLM:


Further study details as provided by William E. Bennett, Jr., Indiana University:

Primary Outcome Measures:
  • Utilization of endoscopy, emergency services, and radiologic services [ Time Frame: 1 Year ]
    Whether the patient had endoscopy scheduled, was seen in the emergency department, or had any radiologic testing


Secondary Outcome Measures:
  • Patient Centered Outcomes determined via patient interviews in Aim 1 of the study [ Time Frame: 1 Year ]
    Specific outcomes determined via patient interviews in Aim 1 of the study.


Estimated Enrollment: 100
Study Start Date: September 2016
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Usual Subspecialty Care

Once a subject is screened positive for anxiety or depression, the subspecialty provider is informed of the positive screen, and left to manage or refer the condition as per usual care by that provider.

Intervention: Depression / anxiety screen + clinician informed.

Other: Notification of Subspecialist
The automated screening tool determines a positive or negative screen, then informs the clinician.
Active Comparator: Integrated Psychology Care

Once a subject is screened positive for anxiety or depression, an automated psychology referral occurs, in addition to any intervention determined by the subspecialty provider.

Intervention: Depression / anxiety screen + clinician informed + automated psychologist visit.

Other: Automated Psychology Services
The automated screening tool determines a positive or negative screen, then informs the clinician, and also automates a psychology visit.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patients seen at the pediatric GI office who are screened for anxiety and depression as part of usual care.

Exclusion Criteria:

  • Patients over the age of 18 or under the age of 10.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT02773706


Contacts
Contact: William E Bennett, M.D. 317-278-9616 webjr@iu.edu

Sponsors and Collaborators
Indiana University
Agency for Healthcare Research and Quality (AHRQ)
  More Information

Responsible Party: William E. Bennett, Jr., Assistant Professor of Pediatrics, Indiana University
ClinicalTrials.gov Identifier: NCT02773706     History of Changes
Other Study ID Numbers: DECADES
First Submitted: June 19, 2015
First Posted: May 16, 2016
Last Update Posted: May 16, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders


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