Detecting and Evaluating Childhood and Anxiety and Depression Effectively in Subspecialties

NCT02773706 | Completed DMC

• 1 other identifier: DECADES
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Depression

Outcome Measures

Primary Outcomes (2)

• Quality of life (baseline)

  Baseline quality of life measurement will be determined using the PedsQL instrument. Both the general PedsQL instrument and the PedsQL gastroenterology symptom index will be used for baseline and followup measures. PedsQL Minimum score: 0 (Worse outcome) PedsQL Maximum score: 100 (Better outcome)

  Baseline

• Quality of life (followup)

  Baseline quality of life measurement will be determined using the PedsQL instrument. Both the general PedsQL instrument and the PedsQL gastroenterology symptom index will be used for baseline and followup measures. PedsQL Minimum score: 0 (Worse outcome) PedsQL Maximum score: 100 (Better outcome)

  Within 6 months

Secondary Outcomes (5)

• Utilization of endoscopy

  Within 6 months

• Utilization of radiologic testing

  6 months

• Utilization of laboratory testing

  6 months

• Utilization of emergency department visits

  6 months

• Utilization of outpatient gastroenterology

  6 months

Study Arms (2)

Usual Subspecialty Care

EXPERIMENTAL

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

Integrated Psychology Care

ACTIVE COMPARATOR

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

Interventions

Automated Psychology Services OTHER

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

Integrated Psychology Care

Notification of Subspecialist OTHER

The automated screening tool determines a positive or negative screen, then informs the clinician.

Usual Subspecialty Care

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Patients over the age of 18 or under the age of 10.

Sponsors & Collaborators

• Indiana University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Indiana University Health North Hospital

Carmel, Indiana, 46074, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: June 19, 2015
• First Posted: May 16, 2016
• Study Start: December 18, 2017
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)