Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04369924
Other study ID # 20190535
Secondary ID R34MH118316
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2020
Est. completion date April 30, 2023

Study information

Verified date May 2024
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 1262
Est. completion date April 30, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers No
Gender All
Age group 11 Years to 17 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
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.

Locations

Country Name City State
United States Health Connect America Nashville Tennessee

Sponsors (3)

Lead Sponsor Collaborator
University of Miami National Institute of Mental Health (NIMH), Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04156373 - Fuerte Program for Newcomer Immigrant Youth N/A
Not yet recruiting NCT05251779 - A Clinical Study on the Effects of Inhalation of Volatile Oil of Cang-Ai Via the Nose on Patients With Depression Early Phase 1
Completed NCT05370443 - Effectiveness of an Online Life Skills-based Intervention on Mental Health N/A
Completed NCT03839225 - Effectiveness of a Community - Based Cross-sector Network for the Management of Mental Health Problems and Disorders Associated With Forced Displacement Due to Armed Conflict in the Municipality of Soacha - Cundinamarca N/A
Recruiting NCT06311838 - Building Social and Structural Connections for the Prevention of Opioid Use Disorder Among Youth Experiencing Homelessness N/A
Withdrawn NCT05670990 - Equine Assisted Services in Children and Adolescents With Mental Illness N/A
Recruiting NCT05543083 - Cognitive-Behavioral Therapy and Exercise Training in Adolescents At-Risk for Type 2 Diabetes N/A
Recruiting NCT04333797 - Psychiatry of Transition in a World in Transition N/A
Not yet recruiting NCT06407258 - Promoting Sleep and Physical Activity Among Adolescent Psychiatric Patients N/A
Enrolling by invitation NCT05812313 - Educators and Young People's Mental Health
Recruiting NCT02072304 - Study of Web- Based Cognitive Behavioral Therapy for Depressed Korean Adolescents N/A
Active, not recruiting NCT03951376 - Universal Preventive Resilience Intervention to Improve and Promote Mental Health for Teenagers N/A
Completed NCT04888780 - Effects of Web-Based Training on HbA1c, Quality of Life and Depression Levels in Adolescents With Type 1 Diabetes N/A
Recruiting NCT05203198 - The PATHway Study: Primary Care Based Depression Prevention in Adolescents N/A
Recruiting NCT05764369 - Optimizing Residential Treatment Gains for Adolescents N/A
Not yet recruiting NCT05865834 - Improvement of Mental Health in Adolescents Using E-health Interventions N/A
Recruiting NCT06403813 - Adolescent Digital Mental Health-Kenya Effectiveness N/A
Completed NCT05809193 - Investigation of the Effects of Family-Focused Therapy in the Early Period of Bipolar Disorder and Psychotic Disorder N/A