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Personalized Assessment of Client Experiences (PACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369924
Recruitment Status : Not yet recruiting
First Posted : April 30, 2020
Last Update Posted : August 28, 2020
Sponsor:
Collaborators:
Vanderbilt University
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Amanda Jensen-Doss, University of Miami

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

Condition or disease Intervention/treatment Phase
Mental Disorder in Adolescence Behavioral: Measurement-Based Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Improving Measurement-Based Care in Youth Mental Health: A Comparison of Unidimensional and Multidimensional Approaches
Estimated Study Start Date : October 15, 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

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.




Primary Outcome Measures :
  1. Change in The Ohio Scales Problem Severity Scale Youth Report [ Time Frame: baseline, 12 weeks ]
    A youth-report measure of youth symptoms ranging from 0 to 100, with higher scores indicating higher general mental health symptoms.

  2. Change in The Ohio Scales Problem Severity Scale Caregiver Report [ Time Frame: baseline, 12 weeks ]
    A caregiver-report measure of youth symptoms ranging from 0 to 100, with higher scores indicating higher general mental health symptoms.

  3. Change in The Ohio Scales Problem Functioning Scale Youth Report [ Time Frame: baseline, 12 weeks ]
    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.

  4. Change in The Ohio Scales Problem Functioning Scale Caregiver Report [ Time Frame: baseline, 12 weeks ]
    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.

  5. Change in Symptoms & Functioning Severity Scale- Youth Report [ Time Frame: baseline, up to 18 months ]
    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.

  6. Change in Symptoms & Functioning Severity Scale- Caregiver Report [ Time Frame: baseline, up to 18 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369924


Contacts
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Contact: Amanda Jensen-Doss, Ph.D. 305-284-8332 ajensendoss@miami.edu

Locations
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United States, Tennessee
Health Connect America
Nashville, Tennessee, United States, 37217
Contact: Amanda Jensen-Doss    305-284-8332    ajensendoss@miami.edu   
Principal Investigator: Amanda Jensen-Doss, Ph.D.         
Principal Investigator: Susan Douglas, Ph.D.         
Sponsors and Collaborators
University of Miami
Vanderbilt University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Susan Douglas, Ph.D. Vanderbilt University
Principal Investigator: Amanda Jensen-Doss, Ph.D. University of Miami
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Responsible Party: Amanda Jensen-Doss, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT04369924    
Other Study ID Numbers: 20190535
R34MH118316 ( U.S. NIH Grant/Contract )
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study data will be shared via the National Institute of Mental Health Data Archive (NDA).
Time Frame: Data will be shared according to the NDA timelines.
Access Criteria: Data access will be according to the NDA guidelines.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mental Disorders