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Personalized Assessment of Client Experiences (PACE)

Primary Purpose

Mental Disorder in Adolescence

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Measurement-Based Care
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Disorder in Adolescence

Eligibility Criteria

11 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female youth between the ages of 11-17 years receiving mental health services at the participating clinics.
  2. The treating clinician is participating in the study and determines that Measurement-Based Care (MBC) is appropriate for the youth.
  3. If the family consents to complete additional research measures, one parent and/or primary caregiver must be available and willing to participate in all study assessments.
  4. Adolescent and at least one parent/guardian are able to complete all study procedures in English or Spanish.

Exclusion Criteria:

  • no other exclusion criteria

Sites / Locations

  • Health Connect America

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Unidimensional Measurement-Based Care

Multidimensional Measurement-Based Care

Arm Description

Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.

Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.

Outcomes

Primary Outcome Measures

Change in The Ohio Scales Problem Severity Scale Youth Report
A youth-report measure of youth symptoms ranging from 0 to 100, with higher scores indicating higher general mental health symptoms.
Change in The Ohio Scales Problem Severity Scale Caregiver Report
A caregiver-report measure of youth symptoms ranging from 0 to 100, with higher scores indicating higher general mental health symptoms.
Change in The Ohio Scales Problem Functioning Scale Youth Report
A youth-report measure of youth functioning in a variety of areas of daily living ranging from 0 to 80, with higher scores indicating better functioning.
Change in The Ohio Scales Problem Functioning Scale Caregiver Report
A caregiver-report measure of youth functioning in a variety of areas of daily living ranging from 0 to 80, with higher scores indicating better functioning.
Change in Symptoms & Functioning Severity Scale- Youth Report
A youth-report measure of youth mental health symptoms. Scores are reported as a total score, ranging from 33 to 86, with higher scores indicating higher symptoms.
Change in Symptoms & Functioning Severity Scale- Caregiver Report
A caregiver-report measure of youth mental health symptoms. Scores are reported as a total score, ranging from 30 to 82, with higher scores indicating higher symptoms.

Secondary Outcome Measures

Full Information

First Posted
April 28, 2020
Last Updated
April 25, 2023
Sponsor
University of Miami
Collaborators
Vanderbilt University, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04369924
Brief Title
Personalized Assessment of Client Experiences
Acronym
PACE
Official Title
Improving Measurement-Based Care in Youth Mental Health: A Comparison of Unidimensional and Multidimensional Approaches
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Vanderbilt University, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare two clinical approaches to youth mental health care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorder in Adolescence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Unidimensional Measurement-Based Care
Arm Type
Experimental
Arm Description
Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
Arm Title
Multidimensional Measurement-Based Care
Arm Type
Experimental
Arm Description
Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
Intervention Type
Behavioral
Intervention Name(s)
Measurement-Based Care
Intervention Description
Both study conditions will receive measurement-based care, which is the systematic, ongoing administration of assessment measures to support clinical decision-making.
Primary Outcome Measure Information:
Title
Change in The Ohio Scales Problem Severity Scale Youth Report
Description
A youth-report measure of youth symptoms ranging from 0 to 100, with higher scores indicating higher general mental health symptoms.
Time Frame
baseline, 12 weeks
Title
Change in The Ohio Scales Problem Severity Scale Caregiver Report
Description
A caregiver-report measure of youth symptoms ranging from 0 to 100, with higher scores indicating higher general mental health symptoms.
Time Frame
baseline, 12 weeks
Title
Change in The Ohio Scales Problem Functioning Scale Youth Report
Description
A youth-report measure of youth functioning in a variety of areas of daily living ranging from 0 to 80, with higher scores indicating better functioning.
Time Frame
baseline, 12 weeks
Title
Change in The Ohio Scales Problem Functioning Scale Caregiver Report
Description
A caregiver-report measure of youth functioning in a variety of areas of daily living ranging from 0 to 80, with higher scores indicating better functioning.
Time Frame
baseline, 12 weeks
Title
Change in Symptoms & Functioning Severity Scale- Youth Report
Description
A youth-report measure of youth mental health symptoms. Scores are reported as a total score, ranging from 33 to 86, with higher scores indicating higher symptoms.
Time Frame
baseline, up to 18 months
Title
Change in Symptoms & Functioning Severity Scale- Caregiver Report
Description
A caregiver-report measure of youth mental health symptoms. Scores are reported as a total score, ranging from 30 to 82, with higher scores indicating higher symptoms.
Time Frame
baseline, up to 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female youth between the ages of 11-17 years receiving mental health services at the participating clinics. The treating clinician is participating in the study and determines that Measurement-Based Care (MBC) is appropriate for the youth. If the family consents to complete additional research measures, one parent and/or primary caregiver must be available and willing to participate in all study assessments. Adolescent and at least one parent/guardian are able to complete all study procedures in English or Spanish. Exclusion Criteria: no other exclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Douglas, Ph.D.
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amanda Jensen-Doss, Ph.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Connect America
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37217
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study data will be shared via the National Institute of Mental Health Data Archive (NDA).
IPD Sharing Time Frame
Data will be shared according to the NDA timelines.
IPD Sharing Access Criteria
Data access will be according to the NDA guidelines.

Learn more about this trial

Personalized Assessment of Client Experiences

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