Trial Outcomes & Findings for Community Study of Outcome Monitoring for Emotional Disorders in Teens (NCT NCT02567266)
NCT ID: NCT02567266
Last Updated: 2021-08-18
Results Overview
This is a independent evaluator rated measure of improvement in symptoms and functioning. The CGI-I has a total range from 1-7 with the lower scores indicating more improvement in functioning.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
196 participants
Primary outcome timeframe
At 16 weeks, at 28 weeks.
Results posted on
2021-08-18
Participant Flow
Participant milestones
| Measure |
Unified Protocol for Adolescents (UP-A)
Participants will be treated with the Unified Protocol for the Treatment of Emotional Disorders in Adolescence (UP-A). Their clinicians will also receive feedback using the Youth Outcomes Questionnaire feedback system, consisting of youth and caregiver progress measures.
The UP-A is an emotion-focused, transdiagnostic approach for adolescents (ages 12-18) with a primary emotional disorder. Clinicians present all skills in the context of the emotions most salient to presenting concerns and adolescent/caregiver conceptualizations of treatment needs, thereby personalizing treatment. The UP-A is delivered in 8-21 weekly sessions, with clinician flexibility regarding the sequencing and depth with which various sections are presented to clients and caregivers, as well as the emotions targeted during the course of the intervention.
|
Treatment as Usual Plus (TAU+)
Participants will be treated by clinicians who receive feedback using the Youth Outcomes Questionnaire, but who otherwise use Treatment as Usual
Youth Outcomes Questionnaire: The YOQ consists of parent- and youth-report measures of symptoms and alliance administered weekly on a tablet computer. The YOQ online system then generates reports to provide clinicians with systematic feedback about client progress, flagging "critical items" that have been endorsed (e.g., suicidality, hallucinations), presenting graphs of ratings over time, and providing empirically-derived "alerts" when clients are failing to progress or showing deterioration. Clinicians will be trained to use this feedback to modify treatment as needed, share it with families as appropriate, and use it to enhance use of supervision.
Treatment as Usual: Clinicians assigned to the TAU condition will be instructed to use whatever treatment methods and outcome monitoring strategies they typically use with adolescents with internalizing disorders.
|
Treatment as Usual (TAU)
Participants will receive Treatment as Usual provided at the study clinics.
Treatment as Usual: Clinicians assigned to the TAU condition will be instructed to use whatever treatment methods and outcome monitoring strategies they typically use with adolescents with internalizing disorders.
|
|---|---|---|---|
|
Overall Study
STARTED
|
68
|
60
|
68
|
|
Overall Study
Midpoint (8 Weeks)
|
54
|
52
|
55
|
|
Overall Study
Post (16 Weeks)
|
49
|
43
|
53
|
|
Overall Study
Follow-up (28 Weeks)
|
45
|
45
|
52
|
|
Overall Study
COMPLETED
|
45
|
45
|
52
|
|
Overall Study
NOT COMPLETED
|
23
|
15
|
16
|
Reasons for withdrawal
| Measure |
Unified Protocol for Adolescents (UP-A)
Participants will be treated with the Unified Protocol for the Treatment of Emotional Disorders in Adolescence (UP-A). Their clinicians will also receive feedback using the Youth Outcomes Questionnaire feedback system, consisting of youth and caregiver progress measures.
The UP-A is an emotion-focused, transdiagnostic approach for adolescents (ages 12-18) with a primary emotional disorder. Clinicians present all skills in the context of the emotions most salient to presenting concerns and adolescent/caregiver conceptualizations of treatment needs, thereby personalizing treatment. The UP-A is delivered in 8-21 weekly sessions, with clinician flexibility regarding the sequencing and depth with which various sections are presented to clients and caregivers, as well as the emotions targeted during the course of the intervention.
|
Treatment as Usual Plus (TAU+)
Participants will be treated by clinicians who receive feedback using the Youth Outcomes Questionnaire, but who otherwise use Treatment as Usual
Youth Outcomes Questionnaire: The YOQ consists of parent- and youth-report measures of symptoms and alliance administered weekly on a tablet computer. The YOQ online system then generates reports to provide clinicians with systematic feedback about client progress, flagging "critical items" that have been endorsed (e.g., suicidality, hallucinations), presenting graphs of ratings over time, and providing empirically-derived "alerts" when clients are failing to progress or showing deterioration. Clinicians will be trained to use this feedback to modify treatment as needed, share it with families as appropriate, and use it to enhance use of supervision.
Treatment as Usual: Clinicians assigned to the TAU condition will be instructed to use whatever treatment methods and outcome monitoring strategies they typically use with adolescents with internalizing disorders.
|
Treatment as Usual (TAU)
Participants will receive Treatment as Usual provided at the study clinics.
Treatment as Usual: Clinicians assigned to the TAU condition will be instructed to use whatever treatment methods and outcome monitoring strategies they typically use with adolescents with internalizing disorders.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
7
|
6
|
|
Overall Study
Lost to Follow-up
|
13
|
8
|
10
|
Baseline Characteristics
Community Study of Outcome Monitoring for Emotional Disorders in Teens
Baseline characteristics by cohort
| Measure |
Unified Protocol for Adolescents (UP-A)
n=68 Participants
Participants will be treated with the Unified Protocol for the Treatment of Emotional Disorders in Adolescence (UP-A). Their clinicians will also receive feedback using the Youth Outcomes Questionnaire feedback system, consisting of youth and caregiver progress measures.
The UP-A is an emotion-focused, transdiagnostic approach for adolescents (ages 12-18) with a primary emotional disorder. Clinicians present all skills in the context of the emotions most salient to presenting concerns and adolescent/caregiver conceptualizations of treatment needs, thereby personalizing treatment. The UP-A is delivered in 8-21 weekly sessions, with clinician flexibility regarding the sequencing and depth with which various sections are presented to clients and caregivers, as well as the emotions targeted during the course of the intervention.
|
Treatment as Usual Plus (TAU+)
n=60 Participants
Participants will be treated by clinicians who receive feedback using the Youth Outcomes Questionnaire, but who otherwise use Treatment as Usual
Youth Outcomes Questionnaire: The YOQ consists of parent- and youth-report measures of symptoms and alliance administered weekly on a tablet computer. The YOQ online system then generates reports to provide clinicians with systematic feedback about client progress, flagging "critical items" that have been endorsed (e.g., suicidality, hallucinations), presenting graphs of ratings over time, and providing empirically-derived "alerts" when clients are failing to progress or showing deterioration. Clinicians will be trained to use this feedback to modify treatment as needed, share it with families as appropriate, and use it to enhance use of supervision.
Treatment as Usual: Clinicians assigned to the TAU condition will be instructed to use whatever treatment methods and outcome monitoring strategies they typically use with adolescents with internalizing disorders.
|
Treatment as Usual (TAU)
n=68 Participants
Participants will receive Treatment as Usual provided at the study clinics.
Treatment as Usual: Clinicians assigned to the TAU condition will be instructed to use whatever treatment methods and outcome monitoring strategies they typically use with adolescents with internalizing disorders.
|
Total
n=196 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
14.69 years
STANDARD_DEVIATION 1.56 • n=5 Participants
|
14.87 years
STANDARD_DEVIATION 1.76 • n=7 Participants
|
14.43 years
STANDARD_DEVIATION 1.72 • n=5 Participants
|
14.65 years
STANDARD_DEVIATION 1.68 • n=4 Participants
|
|
Sex/Gender, Customized
Male
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
47 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
128 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Transgender (Female to Male)
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At 16 weeks, at 28 weeks.Population: Not all participants were able to complete the CGI-I Questionnaire at Post Visit (16 Weeks) and at Follow Up Visit (28 weeks).
This is a independent evaluator rated measure of improvement in symptoms and functioning. The CGI-I has a total range from 1-7 with the lower scores indicating more improvement in functioning.
Outcome measures
| Measure |
Unified Protocol for Adolescents (UP-A)
n=46 Participants
Participants will be treated with the Unified Protocol for the Treatment of Emotional Disorders in Adolescence (UP-A). Their clinicians will also receive feedback using the Youth Outcomes Questionnaire feedback system, consisting of youth and caregiver progress measures.
The UP-A is an emotion-focused, transdiagnostic approach for adolescents (ages 12-18) with a primary emotional disorder. Clinicians present all skills in the context of the emotions most salient to presenting concerns and adolescent/caregiver conceptualizations of treatment needs, thereby personalizing treatment. The UP-A is delivered in 8-21 weekly sessions, with clinician flexibility regarding the sequencing and depth with which various sections are presented to clients and caregivers, as well as the emotions targeted during the course of the intervention.
|
Treatment as Usual Plus (TAU+)
n=41 Participants
Participants will be treated by clinicians who receive feedback using the Youth Outcomes Questionnaire, but who otherwise use Treatment as Usual
Youth Outcomes Questionnaire: The YOQ consists of parent- and youth-report measures of symptoms and alliance administered weekly on a tablet computer. The YOQ online system then generates reports to provide clinicians with systematic feedback about client progress, flagging "critical items" that have been endorsed (e.g., suicidality, hallucinations), presenting graphs of ratings over time, and providing empirically-derived "alerts" when clients are failing to progress or showing deterioration. Clinicians will be trained to use this feedback to modify treatment as needed, share it with families as appropriate, and use it to enhance use of supervision.
Treatment as Usual: Clinicians assigned to the TAU condition will be instructed to use whatever treatment methods and outcome monitoring strategies they typically use with adolescents with internalizing disorders.
|
Treatment as Usual (TAU)
n=49 Participants
Participants will receive Treatment as Usual provided at the study clinics.
Treatment as Usual: Clinicians assigned to the TAU condition will be instructed to use whatever treatment methods and outcome monitoring strategies they typically use with adolescents with internalizing disorders.
|
|---|---|---|---|
|
Clinical Global Impression - Improvement (CGI-I) Scores
Post (16 weeks)
|
2.85 score on a scale
Standard Deviation .965
|
3.20 score on a scale
Standard Deviation 1.167
|
3.02 score on a scale
Standard Deviation .878
|
|
Clinical Global Impression - Improvement (CGI-I) Scores
Follow-up (28 weeks)
|
2.47 score on a scale
Standard Deviation .894
|
2.45 score on a scale
Standard Deviation .904
|
2.76 score on a scale
Standard Deviation 1.128
|
SECONDARY outcome
Timeframe: At 16 weeks, at 28 weeks.Population: Not all participants were able to complete the CGI-S Questionnaire at Post Visit (16 Weeks) and at Follow Up Visit (28 weeks).
This is a independent evaluator rated measure of severity of symptoms. The CGI-S has a total range from 1-7 with the higher scores indicating higher symptom severity.
Outcome measures
| Measure |
Unified Protocol for Adolescents (UP-A)
n=46 Participants
Participants will be treated with the Unified Protocol for the Treatment of Emotional Disorders in Adolescence (UP-A). Their clinicians will also receive feedback using the Youth Outcomes Questionnaire feedback system, consisting of youth and caregiver progress measures.
The UP-A is an emotion-focused, transdiagnostic approach for adolescents (ages 12-18) with a primary emotional disorder. Clinicians present all skills in the context of the emotions most salient to presenting concerns and adolescent/caregiver conceptualizations of treatment needs, thereby personalizing treatment. The UP-A is delivered in 8-21 weekly sessions, with clinician flexibility regarding the sequencing and depth with which various sections are presented to clients and caregivers, as well as the emotions targeted during the course of the intervention.
|
Treatment as Usual Plus (TAU+)
n=41 Participants
Participants will be treated by clinicians who receive feedback using the Youth Outcomes Questionnaire, but who otherwise use Treatment as Usual
Youth Outcomes Questionnaire: The YOQ consists of parent- and youth-report measures of symptoms and alliance administered weekly on a tablet computer. The YOQ online system then generates reports to provide clinicians with systematic feedback about client progress, flagging "critical items" that have been endorsed (e.g., suicidality, hallucinations), presenting graphs of ratings over time, and providing empirically-derived "alerts" when clients are failing to progress or showing deterioration. Clinicians will be trained to use this feedback to modify treatment as needed, share it with families as appropriate, and use it to enhance use of supervision.
Treatment as Usual: Clinicians assigned to the TAU condition will be instructed to use whatever treatment methods and outcome monitoring strategies they typically use with adolescents with internalizing disorders.
|
Treatment as Usual (TAU)
n=49 Participants
Participants will receive Treatment as Usual provided at the study clinics.
Treatment as Usual: Clinicians assigned to the TAU condition will be instructed to use whatever treatment methods and outcome monitoring strategies they typically use with adolescents with internalizing disorders.
|
|---|---|---|---|
|
Clinical Global Impression - Severity (CGI-S) Scores
Post (16 weeks)
|
4.39 score on a scale
Standard Deviation 1.341
|
4.71 score on a scale
Standard Deviation 1.230
|
4.41 score on a scale
Standard Deviation 1.153
|
|
Clinical Global Impression - Severity (CGI-S) Scores
Follow-up (28 weeks)
|
3.98 score on a scale
Standard Deviation 1.559
|
4.00 score on a scale
Standard Deviation 1.396
|
4.02 score on a scale
Standard Deviation 1.377
|
SECONDARY outcome
Timeframe: At 16 weeks, at 28 weeks.Population: Not all participants were able to complete the CGAS Questionnaire at Post Visit (16 Weeks) and at Follow Up Visit (28 weeks).
This is a independent evaluator rated measure of global functional impairment.The GCAS has a total range from 1-100 with the higher scores indicating better functioning.
Outcome measures
| Measure |
Unified Protocol for Adolescents (UP-A)
n=46 Participants
Participants will be treated with the Unified Protocol for the Treatment of Emotional Disorders in Adolescence (UP-A). Their clinicians will also receive feedback using the Youth Outcomes Questionnaire feedback system, consisting of youth and caregiver progress measures.
The UP-A is an emotion-focused, transdiagnostic approach for adolescents (ages 12-18) with a primary emotional disorder. Clinicians present all skills in the context of the emotions most salient to presenting concerns and adolescent/caregiver conceptualizations of treatment needs, thereby personalizing treatment. The UP-A is delivered in 8-21 weekly sessions, with clinician flexibility regarding the sequencing and depth with which various sections are presented to clients and caregivers, as well as the emotions targeted during the course of the intervention.
|
Treatment as Usual Plus (TAU+)
n=41 Participants
Participants will be treated by clinicians who receive feedback using the Youth Outcomes Questionnaire, but who otherwise use Treatment as Usual
Youth Outcomes Questionnaire: The YOQ consists of parent- and youth-report measures of symptoms and alliance administered weekly on a tablet computer. The YOQ online system then generates reports to provide clinicians with systematic feedback about client progress, flagging "critical items" that have been endorsed (e.g., suicidality, hallucinations), presenting graphs of ratings over time, and providing empirically-derived "alerts" when clients are failing to progress or showing deterioration. Clinicians will be trained to use this feedback to modify treatment as needed, share it with families as appropriate, and use it to enhance use of supervision.
Treatment as Usual: Clinicians assigned to the TAU condition will be instructed to use whatever treatment methods and outcome monitoring strategies they typically use with adolescents with internalizing disorders.
|
Treatment as Usual (TAU)
n=49 Participants
Participants will receive Treatment as Usual provided at the study clinics.
Treatment as Usual: Clinicians assigned to the TAU condition will be instructed to use whatever treatment methods and outcome monitoring strategies they typically use with adolescents with internalizing disorders.
|
|---|---|---|---|
|
Children's Global Assessment Scale (CGAS) Scores
Post (16 weeks)
|
53.22 score on a scale
Standard Deviation 9.575
|
52.05 score on a scale
Standard Deviation 9.047
|
52.29 score on a scale
Standard Deviation 8.571
|
|
Children's Global Assessment Scale (CGAS) Scores
Follow-up (28 weeks)
|
56.51 score on a scale
Standard Deviation 12.230
|
56.76 score on a scale
Standard Deviation 12.056
|
56.00 score on a scale
Standard Deviation 11.281
|
Adverse Events
Unified Protocol for Adolescents (UP-A)
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment as Usual Plus (TAU+)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment as Usual (TAU)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Unified Protocol for Adolescents (UP-A)
n=68 participants at risk
Participants will be treated with the Unified Protocol for the Treatment of Emotional Disorders in Adolescence (UP-A). Their clinicians will also receive feedback using the Youth Outcomes Questionnaire feedback system, consisting of youth and caregiver progress measures.
The UP-A is an emotion-focused, transdiagnostic approach for adolescents (ages 12-18) with a primary emotional disorder. Clinicians present all skills in the context of the emotions most salient to presenting concerns and adolescent/caregiver conceptualizations of treatment needs, thereby personalizing treatment. The UP-A is delivered in 8-21 weekly sessions, with clinician flexibility regarding the sequencing and depth with which various sections are presented to clients and caregivers, as well as the emotions targeted during the course of the intervention.
|
Treatment as Usual Plus (TAU+)
n=60 participants at risk
Participants will be treated by clinicians who receive feedback using the Youth Outcomes Questionnaire, but who otherwise use Treatment as Usual
Youth Outcomes Questionnaire: The YOQ consists of parent- and youth-report measures of symptoms and alliance administered weekly on a tablet computer. The YOQ online system then generates reports to provide clinicians with systematic feedback about client progress, flagging "critical items" that have been endorsed (e.g., suicidality, hallucinations), presenting graphs of ratings over time, and providing empirically-derived "alerts" when clients are failing to progress or showing deterioration. Clinicians will be trained to use this feedback to modify treatment as needed, share it with families as appropriate, and use it to enhance use of supervision.
Treatment as Usual: Clinicians assigned to the TAU condition will be instructed to use whatever treatment methods and outcome monitoring strategies they typically use with adolescents with internalizing disorders.
|
Treatment as Usual (TAU)
n=68 participants at risk
Participants will receive Treatment as Usual provided at the study clinics.
Treatment as Usual: Clinicians assigned to the TAU condition will be instructed to use whatever treatment methods and outcome monitoring strategies they typically use with adolescents with internalizing disorders.
|
|---|---|---|---|
|
Psychiatric disorders
Hospitalization due to Suicidality
|
4.4%
3/68 • 28 weeks.
|
1.7%
1/60 • 28 weeks.
|
1.5%
1/68 • 28 weeks.
|
|
Psychiatric disorders
Suicidal behavior
|
2.9%
2/68 • 28 weeks.
|
1.7%
1/60 • 28 weeks.
|
0.00%
0/68 • 28 weeks.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place