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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369924
Recruitment Status : Enrolling by invitation
First Posted : April 30, 2020
Last Update Posted : November 13, 2020
Sponsor:
Collaborators:
Vanderbilt University
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Amanda Jensen-Doss, University of Miami

Tracking Information
First Submitted Date  ICMJE April 28, 2020
First Posted Date  ICMJE April 30, 2020
Last Update Posted Date November 13, 2020
Actual Study Start Date  ICMJE November 1, 2020
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Personalized Assessment of Client Experiences
Official Title  ICMJE Improving Measurement-Based Care in Youth Mental Health: A Comparison of Unidimensional and Multidimensional Approaches
Brief Summary The purpose of this study is to compare two clinical approaches to youth mental health care.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Mental Disorder in Adolescence
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Measurement-Based Care
  • 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.
    Intervention: Behavioral: Measurement-Based Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: April 28, 2020)
900
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04369924
Other Study ID Numbers  ICMJE 20190535
R34MH118316 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Amanda Jensen-Doss, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE
  • Vanderbilt University
  • National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Susan Douglas, Ph.D. Vanderbilt University
Principal Investigator: Amanda Jensen-Doss, Ph.D. University of Miami
PRS Account University of Miami
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP