Personalized Assessment of Client Experiences (PACE)

Improving Measurement-Based Care in Youth Mental Health: A Comparison of Unidimensional and Multidimensional Approaches

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

Study Overview

• Status: Completed
• Conditions: Mental Disorder in Adolescence
• Intervention / Treatment: Behavioral: Measurement-Based Care

• Study Type: Interventional
• Enrollment (Actual): 1262
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37217
      • Health Connect America

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unidimensional Measurement-Based Care; 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.	Behavioral: Measurement-Based Care; Both study conditions will receive measurement-based care, which is the systematic, ongoing administration of assessment measures to support clinical decision-making.
Experimental: Multidimensional Measurement-Based Care; 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.	Behavioral: Measurement-Based Care; Both study conditions will receive measurement-based care, which is the systematic, ongoing administration of assessment measures to support clinical decision-making.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, 12 weeks
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.	baseline, 12 weeks
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.	baseline, 12 weeks
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.	baseline, 12 weeks
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.	baseline, up to 18 months
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.	baseline, up to 18 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute of Mental Health (NIMH); Vanderbilt University
• Investigators: Principal Investigator: Susan Douglas, Ph.D., Vanderbilt University; Principal Investigator: Amanda Jensen-Doss, Ph.D., University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: 20190535; R34MH118316 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No