Mental Disorder in Adolescence
Conditions
Brief summary
The purpose of this study is to compare two clinical approaches to youth mental health 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.
Sponsors
Vanderbilt University
National Institute of Mental Health (NIMH)
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
11 Years to 17 Years
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
* no other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in The Ohio Scales Problem Severity Scale Youth Report | 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 | 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 | 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 | 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 | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
All data reflect adolescent characteristics. Caregivers were not participants in the study.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 637 |
| 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.
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. | 624 |
| Total | 1,261 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 302 | 339 |
Baseline characteristics
| Characteristic | Unidimensional Measurement-Based Care | Multidimensional Measurement-Based Care | Total |
|---|---|---|---|
| Age, Continuous | 14.0 years STANDARD_DEVIATION 2.1 | 13.9 years STANDARD_DEVIATION 2 | 14.0 years STANDARD_DEVIATION 2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 18 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 521 Participants | 494 Participants | 1015 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 100 Participants | 112 Participants | 212 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 43 Participants | 62 Participants | 105 Participants |
| Race (NIH/OMB) More than one race | 16 Participants | 16 Participants | 32 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 111 Participants | 124 Participants | 235 Participants |
| Race (NIH/OMB) White | 466 Participants | 422 Participants | 888 Participants |
| Sex: Female, Male Female | 339 Participants | 339 Participants | 678 Participants |
| Sex: Female, Male Male | 298 Participants | 285 Participants | 583 Participants |
| Symptoms & Functioning Severity Scale- Caregiver Report | 49.6 scores on a scale STANDARD_DEVIATION 9.2 | 50.0 scores on a scale STANDARD_DEVIATION 8.9 | 49.8 scores on a scale STANDARD_DEVIATION 9.1 |
| Symptoms & Functioning Severity Scale- Youth Report | 52.1 scores on a scale STANDARD_DEVIATION 10 | 50.9 scores on a scale STANDARD_DEVIATION 10 | 51.6 scores on a scale STANDARD_DEVIATION 10 |
| The Ohio Scales Problem Functioning Scale Caregiver Report | 49.3 scores on a scale STANDARD_DEVIATION 17.6 | 47.7 scores on a scale STANDARD_DEVIATION 20.1 | 48.6 scores on a scale STANDARD_DEVIATION 18.6 |
| The Ohio Scales Problem Functioning Scale Youth Report | 55.1 scores on a scale STANDARD_DEVIATION 16.6 | 53.9 scores on a scale STANDARD_DEVIATION 15.4 | 54.6 scores on a scale STANDARD_DEVIATION 16 |
| The Ohio Scales Problem Severity Scale Caregiver Report | 19.9 scores on a scale STANDARD_DEVIATION 13.9 | 19.3 scores on a scale STANDARD_DEVIATION 14.4 | 19.6 scores on a scale STANDARD_DEVIATION 14 |
| The Ohio Scales Problem Severity Scale Youth Report | 19.1 scores on a scale STANDARD_DEVIATION 16 | 20.6 scores on a scale STANDARD_DEVIATION 16.2 | 19.8 scores on a scale STANDARD_DEVIATION 16 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 637 | 0 / 624 |
| other Total, other adverse events | 0 / 637 | 0 / 624 |
| serious Total, serious adverse events | 0 / 637 | 0 / 624 |
Outcome results
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.
Time frame: baseline, up to 18 months
Population: We analyzed data from caregivers who completed at least two sets of measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unidimensional Measurement-Based Care | Change in Symptoms & Functioning Severity Scale- Caregiver Report | -2.3 score on a scale | Standard Deviation 0.4 |
| Multidimensional Measurement-Based Care | Change in Symptoms & Functioning Severity Scale- Caregiver Report | -2.6 score on a scale | Standard Deviation 0.4 |
p-value: 0.59Mixed Models Analysis
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.
Time frame: baseline, up to 18 months
Population: We analyzed youth who completed at least two sets of measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unidimensional Measurement-Based Care | Change in Symptoms & Functioning Severity Scale- Youth Report | -3.7 score on a scale | Standard Deviation 0.6 |
| Multidimensional Measurement-Based Care | Change in Symptoms & Functioning Severity Scale- Youth Report | -3.3 score on a scale | Standard Deviation 0.4 |
p-value: 0.82Mixed Models Analysis
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.
Time frame: baseline, 12 weeks
Population: This measure was only administered to participants who consented to completing additional research measures. Many of these were then lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unidimensional Measurement-Based Care | Change in The Ohio Scales Problem Functioning Scale Caregiver Report | 2.4 score on a scale | Standard Deviation 6.5 |
| Multidimensional Measurement-Based Care | Change in The Ohio Scales Problem Functioning Scale Caregiver Report | -13.4 score on a scale | Standard Deviation 25.3 |
p-value: 0.07ANOVA
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.
Time frame: baseline, 12 weeks
Population: This measure was only administered to participants who consented to completing additional research measures. Many of these were then lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unidimensional Measurement-Based Care | Change in The Ohio Scales Problem Functioning Scale Youth Report | 5.5 score on a scale | Standard Deviation 15.6 |
| Multidimensional Measurement-Based Care | Change in The Ohio Scales Problem Functioning Scale Youth Report | -4.5 score on a scale | Standard Deviation 12 |
p-value: 0.7ANOVA
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.
Time frame: baseline, 12 weeks
Population: This measure was only administered to participants who consented to completing additional research measures. Many of these were then lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unidimensional Measurement-Based Care | Change in The Ohio Scales Problem Severity Scale Caregiver Report | -2.2 score on a scale | Standard Deviation 7.8 |
| Multidimensional Measurement-Based Care | Change in The Ohio Scales Problem Severity Scale Caregiver Report | 5.4 score on a scale | Standard Deviation 9.9 |
p-value: 0.12ANOVA
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.
Time frame: baseline, 12 weeks
Population: This measure was only administered to participants who consented to completing additional research measures. Many of these were then lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unidimensional Measurement-Based Care | Change in The Ohio Scales Problem Severity Scale Youth Report | -4.4 score on a scale | Standard Deviation 9.7 |
| Multidimensional Measurement-Based Care | Change in The Ohio Scales Problem Severity Scale Youth Report | 4.92 score on a scale | Standard Deviation 9.3 |
p-value: 0.25ANOVA