Personalized Assessment of Client Experiences

Mental Disorder in Adolescence Clinical Trial

— PACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04369924
• Other study ID #: 20190535
• Secondary ID: R34MH118316
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1262
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorder in Adolescence
• Mental Disorders

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Health Connect America	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
University of Miami	National Institute of Mental Health (NIMH), Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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