NCT03336892

Brief Summary

This study seeks to quantify the impact of recommended mental health care coordination practices on patient experiences of care, (i.e. satisfaction, stigma, quality of mental health care), evaluate the efficiency and effectiveness of the intervention (i.e. care coordination, timing, unmet needs), and assess mental health outcomes (i.e. symptoms and functioning, involvement with law enforcement/juvenile justice system; rates of substance use /abuse, service utilization) in a population of 16-22 year-old youth receiving primary care in a D.C. urban academic adolescent medicine practice, using standardized outcome measures.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

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

April 1, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

3 years

First QC Date

October 23, 2017

Last Update Submit

February 22, 2021

Conditions

Keywords

Care Coordination

Outcome Measures

Primary Outcomes (1)

  • Connection to mental healthcare

    Number of study participants self-reported receiving mental health care services since enrollment

    2 years

Secondary Outcomes (5)

  • Patient Experiences

    2 years

  • Depression symptoms

    2 years

  • Mental Health Stigma

    2 years

  • Patterns of substance use

    2 years

  • Adverse Childhood Events

    2 years

Study Arms (2)

Intervention

EXPERIMENTAL

Enhanced usual care with written mental health resources and system navigation information in addition to individualized mental health care coordination by a dedicated specially trained mental health care coordinator.

Behavioral: Mental Health Care Coordination

Control

NO INTERVENTION

Enhanced usual care with written mental health resources and system navigation information.

Interventions

Enhanced usual care with written mental health resources and system navigation information in addition to individualized mental health care coordination by a dedicated specially trained mental health care coordinator.

Intervention

Eligibility Criteria

Age16 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • has a diagnosis of serious emotional disturbance/serious mental illness
  • has not received outpatient mental health services in the past 30 days

You may not qualify if:

  • does not have a diagnosis of serious emotional disturbance/serious mental illness
  • has received outpatient mental health services in the past 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Lisa K Tuchman, MD, MPH

    Children's National Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 23, 2017

First Posted

November 8, 2017

Study Start

April 1, 2016

Primary Completion

March 31, 2019

Study Completion

October 31, 2019

Last Updated

February 23, 2021

Record last verified: 2021-02