Mental Disorder in AdolescencePACENCT04369924

Personalized Assessment of Client Experiences

A study testing Unidimensional Measurement-Based Care and Multidimensional Measurement-Based Care in people with Mental Disorder in Adolescence, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 11 to 17 years
Conditions the study is for: Mental Disorder in Adolescence
What is being tested?: Unidimensional Measurement-Based Care and Multidimensional Measurement-Based Care
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,261 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2020to 30 Apr 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 11 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male or female youth between the ages of 11-17 years receiving mental health services at the participating clinics.
The treating clinician is participating in the study and determines that Measurement-Based Care (MBC) is appropriate for the youth.
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.
Adolescent and at least one parent/guardian are able to complete all study procedures in English or Spanish.

Who cannot join

no other exclusion criteria

Trial locations and contacts

1 site in 1 country.

United States1 site

Health Connect America
Nashville, Tennessee, 37217

Other trials in United States

About this study

Official title: 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.

Conditions: Mental Disorder in Adolescence
Being tested: Unidimensional Measurement-Based Care, Multidimensional Measurement-Based Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Unidimensional Measurement-Based CareBehavioural
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 CareBehavioural
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.

Study groups in NCT04369924
Study group	Role	What they receive
Unidimensional Measurement-Based Care	Experimental	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. Receives: Behavioral: Unidimensional Measurement-Based Care
Multidimensional Measurement-Based Care	Experimental	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. Receives: Behavioral: Multidimensional Measurement-Based Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202030 Apr 2023

First posted30 Apr 2020
Study start1 Nov 2020
Primary completion30 Apr 2023
Study completion30 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Mental Disorder in AdolescenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 1,261 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04369924
Sponsor's protocol ID: 20190535
Other IDs: R34MH118316
Acronym: PACE
Status last verified: Jun 2024
First submitted: 28 Apr 2020
Last updated: 3 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Study data will be shared via the National Institute of Mental Health Data Archive (NDA).

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Mental Disorder in Adolescence trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Measurement-Based Care in Youth Mental Health: A Comparison of Unidimensional and Multidimensional Approaches
ClinicalTrials.gov ID: NCT04369924
Acronym / sponsor ID: PACE / 20190535
Conditions: Mental Disorder in Adolescence
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,261 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Collaborators: Vanderbilt University, National Institute of Mental Health (NIMH)
Study start: 1 Nov 2020 (actual)
Primary completion: 30 Apr 2023 (actual)
Study completion: 30 Apr 2023 (actual)
First posted: 30 Apr 2020 (actual)
Results: Posted 3 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Unidimensional Measurement-Based Care	Experimental	Behavioral: Unidimensional Measurement-Based CareYouth 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	Experimental	Behavioral: Multidimensional Measurement-Based CareYouth 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.

Who may qualify

Ages: 11 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Male or female youth between the ages of 11-17 years receiving mental health services at the participating clinics.
The treating clinician is participating in the study and determines that Measurement-Based Care (MBC) is appropriate for the youth.
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.
Adolescent and at least one parent/guardian are able to complete all study procedures in English or Spanish.

Key exclusion criteria (1 listed)

no other exclusion criteria

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Unidimensional Measurement-Based CareYouth 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.	Behavioural	Unidimensional Measurement-Based Care
Multidimensional Measurement-Based CareYouth 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.	Behavioural	Multidimensional Measurement-Based Care

Primary outcome

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.

Results and safety

Results posted to the registry on 3 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Unidimensional Measurement-Based Care	637	335
Multidimensional Measurement-Based Care	624	285

Primary outcome: Change in The Ohio Scales Problem Severity Scale Youth Report

Time frame: baseline, 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Unidimensional Measurement-Based Care n = 9	Multidimensional Measurement-Based Care n = 2
Value	-4.4 (9.7)	4.92 (9.3)

Unidimensional Measurement-Based Care vs Multidimensional Measurement-Based Care: F test for time by condition interaction: 1.49, p = .25, ANOVA

Population analysed: This measure was only administered to participants who consented to completing additional research measures. Many of these were then lost to follow-up.

Primary outcome: Change in The Ohio Scales Problem Severity Scale Caregiver Report

Time frame: baseline, 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Unidimensional Measurement-Based Care n = 11	Multidimensional Measurement-Based Care n = 5
Value	-2.2 (7.8)	5.4 (9.9)

Unidimensional Measurement-Based Care vs Multidimensional Measurement-Based Care: F test for time by condition interaction: 2.80, p = .12, ANOVA

Population analysed: This measure was only administered to participants who consented to completing additional research measures. Many of these were then lost to follow-up.

Primary outcome: Change in The Ohio Scales Problem Functioning Scale Youth Report

Time frame: baseline, 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Unidimensional Measurement-Based Care n = 8	Multidimensional Measurement-Based Care n = 2
Value	5.5 (15.6)	-4.5 (12.0)

Unidimensional Measurement-Based Care vs Multidimensional Measurement-Based Care: F test for time by condition interaction: .70, p = .70, ANOVA

Population analysed: This measure was only administered to participants who consented to completing additional research measures. Many of these were then lost to follow-up.

Primary outcome: Change in The Ohio Scales Problem Functioning Scale Caregiver Report

Time frame: baseline, 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Unidimensional Measurement-Based Care n = 10	Multidimensional Measurement-Based Care n = 5
Value	2.4 (6.5)	-13.4 (25.3)

Unidimensional Measurement-Based Care vs Multidimensional Measurement-Based Care: F test for time by condition interaction: 3.67, p = .07, ANOVA

Population analysed: This measure was only administered to participants who consented to completing additional research measures. Many of these were then lost to follow-up.

Adverse events

Time frame: Up to 18 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Unidimensional Measurement-Based Care	0 of 637 (0%)	0 of 637 (0%)	0 of 637
Multidimensional Measurement-Based Care	0 of 624 (0%)	0 of 624 (0%)	0 of 624

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Study data will be shared via the National Institute of Mental Health Data Archive (NDA).

Related trials for Mental Disorder in Adolescence

RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
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Cognitive and Behavioral Approaches to Reduce Binge Eating and Excess Weight in Adolescents (Online)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Susan Douglas, Ph.D. principal investigator

Vanderbilt University

Amanda Jensen-Doss, Ph.D. principal investigator

University of Miami

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Unidimensional Measurement-Based Care and Multidimensional Measurement-Based Care in people with Mental Disorder in Adolescence, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in The Ohio Scales Problem Severity Scale Youth Report (time frame: baseline, 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04369924.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.