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CompletedNCT04369924PACEUpdated Jul 3, 2024Results posted

Personalized Assessment of Client Experiences

An interventional study of Unidimensional Measurement-Based Care and Multidimensional Measurement-Based Care in Mental Disorder in Adolescence, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 11 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-07-03.

Sponsored by University of Miami · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
1,261
Allocation
Randomized
Ages
11 Years to 17 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Mental Disorder in Adolescence

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03

In context

Mental Disorders

2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.

This study's enrollment of 1,261 is above the median of 94 across 1,574 interventional studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • no other exclusion criteria
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
1,261 participants (actual)

Study arms

  • 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: Unidimensional 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.

    Behavioral: Multidimensional Measurement-Based Care

Interventions

  • BehavioralUnidimensional 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.

  • BehavioralMultidimensional 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline, 12 weeks

  2. 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.

    Time frame: baseline, 12 weeks

  3. 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.

    Time frame: baseline, 12 weeks

  4. 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.

    Time frame: baseline, 12 weeks

  5. 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.

    Time frame: baseline, up to 18 months

  6. 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.

    Time frame: baseline, up to 18 months

07

Results

Posted Jul 3, 2024
Limitations and caveats
The purpose of this trial was to pilot study procedures for a fully-powered trial. The procedures for recruiting and retaining research subsample participants were not successful, leading to a small number of participants with available data on the Ohio Scales outcome measures.

Participant flow

Participant flow — Overall Study
MilestoneUnidimensional Measurement-Based CareMultidimensional Measurement-Based Care
Started637624
Completed at least one measurement-based care measure411370
Consented to complete additional research measures6754
Completed335285
Not completed302339
Withdrew: Lost to follow-up302339

Outcome measures

PrimaryChange 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.

Time frame:
baseline, 12 weeks
Reported as:
Mean · score on a scale
Change in The Ohio Scales Problem Severity Scale Youth Report
score on a scaleUnidimensional Measurement-Based CareMultidimensional Measurement-Based Care
Change in The Ohio Scales Problem Severity Scale Youth Report-4.4 ± 9.74.92 ± 9.3
Statistical analysis
  • Unidimensional Measurement-Based Care vs Multidimensional Measurement-Based Care · ANOVA · p = .25 · F test for time by condition interaction: 1.49
PrimaryChange 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.

Time frame:
baseline, 12 weeks
Reported as:
Mean · score on a scale
Change in The Ohio Scales Problem Severity Scale Caregiver Report
score on a scaleUnidimensional Measurement-Based CareMultidimensional Measurement-Based Care
Change in The Ohio Scales Problem Severity Scale Caregiver Report-2.2 ± 7.85.4 ± 9.9
Statistical analysis
  • Unidimensional Measurement-Based Care vs Multidimensional Measurement-Based Care · ANOVA · p = .12 · F test for time by condition interaction: 2.80
PrimaryChange 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.

Time frame:
baseline, 12 weeks
Reported as:
Mean · score on a scale
Change in The Ohio Scales Problem Functioning Scale Youth Report
score on a scaleUnidimensional Measurement-Based CareMultidimensional Measurement-Based Care
Change in The Ohio Scales Problem Functioning Scale Youth Report5.5 ± 15.6-4.5 ± 12.0
Statistical analysis
  • Unidimensional Measurement-Based Care vs Multidimensional Measurement-Based Care · ANOVA · p = .70 · F test for time by condition interaction: .70
PrimaryChange 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.

Time frame:
baseline, 12 weeks
Reported as:
Mean · score on a scale
Change in The Ohio Scales Problem Functioning Scale Caregiver Report
score on a scaleUnidimensional Measurement-Based CareMultidimensional Measurement-Based Care
Change in The Ohio Scales Problem Functioning Scale Caregiver Report2.4 ± 6.5-13.4 ± 25.3
Statistical analysis
  • Unidimensional Measurement-Based Care vs Multidimensional Measurement-Based Care · ANOVA · p = .07 · F test for time by condition interaction: 3.67
PrimaryChange 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.

Time frame:
baseline, up to 18 months
Reported as:
Mean · score on a scale
Change in Symptoms & Functioning Severity Scale- Youth Report
score on a scaleUnidimensional Measurement-Based CareMultidimensional Measurement-Based Care
Change in Symptoms & Functioning Severity Scale- Youth Report-3.7 ± 0.6-3.3 ± 0.4
Statistical analysis
  • Unidimensional Measurement-Based Care vs Multidimensional Measurement-Based Care · Mixed Models Analysis · p = .82 · Slope: .16
PrimaryChange 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.

Time frame:
baseline, up to 18 months
Reported as:
Mean · score on a scale
Change in Symptoms & Functioning Severity Scale- Caregiver Report
score on a scaleUnidimensional Measurement-Based CareMultidimensional Measurement-Based Care
Change in Symptoms & Functioning Severity Scale- Caregiver Report-2.3 ± 0.4-2.6 ± 0.4
Statistical analysis
  • Unidimensional Measurement-Based Care vs Multidimensional Measurement-Based Care · Mixed Models Analysis · p = .59 · Slope: -2.41

Adverse events

Collected over Up to 18 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Unidimensional Measurement-Based Care0/637 (0%)0/637 (0%)0/637 (0%)
Multidimensional Measurement-Based Care0/624 (0%)0/624 (0%)0/624 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Unidimensional Measurement-Based CareMultidimensional Measurement-Based CareTotal
Mean14.0 ± 2.113.9 ± 2.014.0 ± 2.0
Sex: Female, Male
Sex: Female, Male(Participants)Unidimensional Measurement-Based CareMultidimensional Measurement-Based CareTotal
Female339339678
Male298285583
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Unidimensional Measurement-Based CareMultidimensional Measurement-Based CareTotal
Hispanic or Latino161834
Not Hispanic or Latino5214941015
Unknown or Not Reported100112212
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Unidimensional Measurement-Based CareMultidimensional Measurement-Based CareTotal
American Indian or Alaska Native000
Asian101
Native Hawaiian or Other Pacific Islander000
Black or African American4362105
White466422888
More than one race161632
Unknown or Not Reported111124235
The Ohio Scales Problem Severity Scale Youth Report
The Ohio Scales Problem Severity Scale Youth Report(scores on a scale)Unidimensional Measurement-Based CareMultidimensional Measurement-Based CareTotal
Mean19.1 ± 16.020.6 ± 16.219.8 ± 16.0
The Ohio Scales Problem Severity Scale Caregiver Report
The Ohio Scales Problem Severity Scale Caregiver Report(scores on a scale)Unidimensional Measurement-Based CareMultidimensional Measurement-Based CareTotal
Mean19.9 ± 13.919.3 ± 14.419.6 ± 14.0
The Ohio Scales Problem Functioning Scale Youth Report
The Ohio Scales Problem Functioning Scale Youth Report(scores on a scale)Unidimensional Measurement-Based CareMultidimensional Measurement-Based CareTotal
Mean55.1 ± 16.653.9 ± 15.454.6 ± 16.0
The Ohio Scales Problem Functioning Scale Caregiver Report
The Ohio Scales Problem Functioning Scale Caregiver Report(scores on a scale)Unidimensional Measurement-Based CareMultidimensional Measurement-Based CareTotal
Mean49.3 ± 17.647.7 ± 20.148.6 ± 18.6

2 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Health Connect America
    Nashville, Tennessee 37217, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · May 20, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Study data will be shared via the National Institute of Mental Health Data Archive (NDA).

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04369924
Lead sponsor
University of Miami
Collaborators
Vanderbilt University, National Institute of Mental Health (NIMH)
Responsible party
Amanda Jensen-Doss (Associate Professor, University of Miami) — Principal investigator
First posted
Apr 30, 2020
Start date
Nov 1, 2020
Primary completion
Apr 30, 2023
Completion
Apr 30, 2023
Results posted
Jul 3, 2024
Last update
Jul 3, 2024

Study contacts

Susan Douglas, Ph.D.
principal investigator · Vanderbilt University
Amanda Jensen-Doss, Ph.D.
principal investigator · University of Miami

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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