Personalized Assessment of Client Experiences

NCT04369924 | Completed Results

• 2 other identifiers: 20190535R34MH118316
• Study Type: interventional
• Target: 1,261
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mental Disorder in Adolescence

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

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.

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.

Behavioral: Multidimensional Measurement-Based Care

Interventions

Unidimensional Measurement-Based Care BEHAVIORAL

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.

Unidimensional Measurement-Based Care

Multidimensional Measurement-Based Care BEHAVIORAL

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.

Multidimensional Measurement-Based Care

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• Vanderbilt University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Health Connect America

Nashville, Tennessee, 37217, United States

Location

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.

Results Point of Contact

• Title: Amanda Jensen-Doss
• Organization: University of Miami

ajensendoss@miami.edu

3052848332

Study Officials

• Susan Douglas, Ph.D.

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

• Amanda Jensen-Doss, Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: April 30, 2020
• Study Start: November 1, 2020
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be shared according to the NDA timelines.
• Access Criteria: Data access will be according to the NDA guidelines.

Locations

US (1)