Anxiety, Depression
Conditions
Brief summary
This study is being done to compare three types of talk therapies for youth who struggle with emotional and behavioral problems (e.g., anxiety, sadness, worries) in Community Mental Health Clinics in Connecticut (CT) and Florida (FL).
Interventions
BEHAVIORALUnified Protocol for Adolescents (UP-A)
The UP-A is an emotion-focused, transdiagnostic approach for adolescents (ages 12-18) with a primary emotional disorder. It is a developmental adaptation of the Unified Protocol, a transdiagnostic treatment for adults with emotional disorders. 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.
BEHAVIORALYouth 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.
BEHAVIORALTreatment 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.
Sponsors
University of Connecticut
National Institute of Mental Health (NIMH)
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female adolescents between the ages of 12-18 years at the time of enrollment with clinically significant symptoms of anxiety or depression at baseline. Evidence of clinically significant symptoms will be defined as a Clinical Severity Rating (CSR) greater than or equal to 4 on any DSM-5 defined anxiety disorder (e.g., generalized anxiety disorder, social phobia, selective mutism, separation anxiety disorder) or depressive disorder (e.g., major depressive disorder, persistent depressive disorder), or an adjustment disorder with depressed mood, anxiety, or mixed anxiety and depressed mood. 2. The adolescent is determined by the community mental health center to be eligible for outpatient psychosocial services at the clinic and determined by the study IE to be appropriate for outpatient psychosocial intervention (e.g., no major cognitive impairment or active suicidality) based on clinical interview. 3. The adolescent lives (for at least 50% time) with legal guardian and this guardian is willing to attend treatment sessions and participate in study assessments (every effort will be made to encourage the same caregiver to participate in all assessments). 4. Adolescent and parent/guardian are able to complete all study procedures in English or Spanish.
Exclusion criteria
1. Adolescents will be excluded if they are receiving concurrent psychotherapy, family therapy or similar psychosocial interventions. 2. Consistent with the prior RCT of the UP-A, the use of psychopharmacologic treatments for anxiety or depression is allowable; but the adolescent must be on a stable dosage for 2 months for SSRI or 1 month for benzodiazepine prior to consenting to the study. The type, dosage and frequency of medication will be monitored at all major study assessment points, but subsequent changes will not incur exclusion from the investigation. Adolescents on stable doses of a stimulant for ADHD for at least one month or on a SNRI (e.g., Strattera) for ADHD for at least two months can also be included. 3. Adolescents who are currently suicidal or who have engaged in suicidal behaviors within the past 6 months will be excluded and referred for appropriate clinical intervention. 4. Adolescents with a current substance abuse disorder as determined using the ADIS-5-C/P, will be excluded. 5. Consistent with prior trials of the UP-A, youth with primary conditions not specified for exclusion (e.g., eating disorders, schizophrenia) will be screened. As long as study staff concur that an emotional disorder treatment focus is appropriate, these youth will be included. 6. Adolescents with a reported history of intellectual disability or for whom there is substantial evidence (e.g., multiple learning disorders, extensive school-based accommodations for learning) that the cognitive level of the UP-A would make it inappropriate as an individual therapy modality, as determined via Family Background Questionnaire and/or based on PI judgement, will be excluded. 7. Given additional complexities obtaining informed consent, adolescents who are currently placed in the foster care system will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression - Improvement (CGI-I) Scores | At 16 weeks, at 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression - Severity (CGI-S) Scores | At 16 weeks, at 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. |
| Children's Global Assessment Scale (CGAS) Scores | At 16 weeks, at 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 68 |
| 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. | 60 |
| 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. | 68 |
| Total | 196 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 13 | 8 | 10 |
| Overall Study | Withdrawal by Subject | 10 | 7 | 6 |
Baseline characteristics
| Characteristic | Unified Protocol for Adolescents (UP-A) | Treatment as Usual Plus (TAU+) | Treatment as Usual (TAU) | Total |
|---|---|---|---|---|
| Age, Continuous | 14.69 years STANDARD_DEVIATION 1.56 | 14.87 years STANDARD_DEVIATION 1.76 | 14.43 years STANDARD_DEVIATION 1.72 | 14.65 years STANDARD_DEVIATION 1.68 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants | 21 Participants | 29 Participants | 81 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants | 39 Participants | 39 Participants | 115 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 17 Participants | 13 Participants | 45 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 8 Participants | 9 Participants | 19 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 1 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) White | 47 Participants | 32 Participants | 39 Participants | 118 Participants |
| Sex/Gender, Customized Female | 47 Participants | 40 Participants | 41 Participants | 128 Participants |
| Sex/Gender, Customized Male | 20 Participants | 18 Participants | 27 Participants | 65 Participants |
| Sex/Gender, Customized Other | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized Transgender (Female to Male) | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 68 | 0 / 60 | 0 / 68 |
| other Total, other adverse events | 0 / 68 | 0 / 60 | 0 / 68 |
| serious Total, serious adverse events | 5 / 68 | 2 / 60 | 1 / 68 |
Outcome results
Primary
Clinical Global Impression - Improvement (CGI-I) Scores
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Unified Protocol for Adolescents (UP-A) | Clinical Global Impression - Improvement (CGI-I) Scores | Post (16 weeks) | 2.85 score on a scale | Standard Deviation 0.965 |
| Unified Protocol for Adolescents (UP-A) | Clinical Global Impression - Improvement (CGI-I) Scores | Follow-up (28 weeks) | 2.47 score on a scale | Standard Deviation 0.894 |
| Treatment as Usual Plus (TAU+) | Clinical Global Impression - Improvement (CGI-I) Scores | Post (16 weeks) | 3.20 score on a scale | Standard Deviation 1.167 |
| Treatment as Usual Plus (TAU+) | Clinical Global Impression - Improvement (CGI-I) Scores | Follow-up (28 weeks) | 2.45 score on a scale | Standard Deviation 0.904 |
| Treatment as Usual (TAU) | Clinical Global Impression - Improvement (CGI-I) Scores | Post (16 weeks) | 3.02 score on a scale | Standard Deviation 0.878 |
| Treatment as Usual (TAU) | Clinical Global Impression - Improvement (CGI-I) Scores | Follow-up (28 weeks) | 2.76 score on a scale | Standard Deviation 1.128 |
Comparison: DV = CGI-I at Post-Treatmentp-value: 0.33895% CI: [-0.58, 0.2]Mixed Models Analysis
Comparison: DV = CGI-I at Post Treatmentp-value: 0.42595% CI: [-0.24, 0.57]Mixed Models Analysis
Comparison: DV = CGI-I at Postp-value: 0.0995% CI: [-0.77, 0.06]Mixed Models Analysis
Comparison: DV = CGI-I at Follow-Upp-value: 0.12695% CI: [-0.72, 0.09]Mixed Models Analysis
Comparison: DV = CGI-I at Follow-Upp-value: 0.2895% CI: [-0.65, 0.19]Mixed Models Analysis
Comparison: DV = CGI-I at Follow-Upp-value: 0.69795% CI: [-0.51, 0.34]Mixed Models Analysis
Secondary
Children's Global Assessment Scale (CGAS) Scores
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Unified Protocol for Adolescents (UP-A) | Children's Global Assessment Scale (CGAS) Scores | Post (16 weeks) | 53.22 score on a scale | Standard Deviation 9.575 |
| Unified Protocol for Adolescents (UP-A) | Children's Global Assessment Scale (CGAS) Scores | Follow-up (28 weeks) | 56.51 score on a scale | Standard Deviation 12.23 |
| Treatment as Usual Plus (TAU+) | Children's Global Assessment Scale (CGAS) Scores | Follow-up (28 weeks) | 56.76 score on a scale | Standard Deviation 12.056 |
| Treatment as Usual Plus (TAU+) | Children's Global Assessment Scale (CGAS) Scores | Post (16 weeks) | 52.05 score on a scale | Standard Deviation 9.047 |
| Treatment as Usual (TAU) | Children's Global Assessment Scale (CGAS) Scores | Follow-up (28 weeks) | 56.00 score on a scale | Standard Deviation 11.281 |
| Treatment as Usual (TAU) | Children's Global Assessment Scale (CGAS) Scores | Post (16 weeks) | 52.29 score on a scale | Standard Deviation 8.571 |
Comparison: DV = CGAS at Postp-value: 0.85295% CI: [-2.85, 3.45]Mixed Models Analysis
Comparison: DV = CGAS at Postp-value: 0.91795% CI: [-3.41, 3.07]Mixed Models Analysis
Comparison: DV = CGAS at Postp-value: 0.77895% CI: [-2.81, 3.74]Mixed Models Analysis
Comparison: DV = CGAS at Follow-Upp-value: 0.6695% CI: [-3.3, 5.19]Mixed Models Analysis
Comparison: DV = CGAS at Follow-Upp-value: 0.93595% CI: [-4.55, 4.19]Mixed Models Analysis
Comparison: DV = CGAS at Follow-Upp-value: 0.61595% CI: [-3.29, 5.55]Mixed Models Analysis
Secondary
Clinical Global Impression - Severity (CGI-S) Scores
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Unified Protocol for Adolescents (UP-A) | Clinical Global Impression - Severity (CGI-S) Scores | Post (16 weeks) | 4.39 score on a scale | Standard Deviation 1.341 |
| Unified Protocol for Adolescents (UP-A) | Clinical Global Impression - Severity (CGI-S) Scores | Follow-up (28 weeks) | 3.98 score on a scale | Standard Deviation 1.559 |
| Treatment as Usual Plus (TAU+) | Clinical Global Impression - Severity (CGI-S) Scores | Post (16 weeks) | 4.71 score on a scale | Standard Deviation 1.23 |
| Treatment as Usual Plus (TAU+) | Clinical Global Impression - Severity (CGI-S) Scores | Follow-up (28 weeks) | 4.00 score on a scale | Standard Deviation 1.396 |
| Treatment as Usual (TAU) | Clinical Global Impression - Severity (CGI-S) Scores | Post (16 weeks) | 4.41 score on a scale | Standard Deviation 1.153 |
| Treatment as Usual (TAU) | Clinical Global Impression - Severity (CGI-S) Scores | Follow-up (28 weeks) | 4.02 score on a scale | Standard Deviation 1.377 |
Comparison: DV = CGI-S at Follow-Upp-value: 0.77995% CI: [-0.6, 0.45]Mixed Models Analysis
Comparison: DV = CGI-S at Follow-Upp-value: 0.6695% CI: [-0.42, 0.67]Mixed Models Analysis
Comparison: DV = CGI-S at Postp-value: 0.62995% CI: [-0.51, 0.31]Mixed Models Analysis
Comparison: DV = CGI-S at Postp-value: 0.93895% CI: [-0.41, 0.38]Mixed Models Analysis
Comparison: DV = CGI-S at Postp-value: 0.6895% CI: [-0.32, 0.49]Mixed Models Analysis
Comparison: DV = CGI-S at Follow-Upp-value: 0.47995% CI: [-0.75, 0.35]Mixed Models Analysis