An interventional study of The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children and The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents in Mental Health Issue, Anxiety Disorder and Depressive Disorder, sponsored by University of Miami. Recruiting at 1 site in United States. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by University of Miami · Not applicable, Interventional, and Treatment
Among 18 studies in Anxiety Disorders by University of Miami — 5 open to participants now, 6 under way, none of them phase 3. Anxiety Disorders · University of Miami.
Among the 18 studies in Anxiety Disorders by University of Miami, this one is the 2nd largest by planned enrollment of the 17 interventional ones, is the only one that started in 2023, is one of 16 with no phase, and was the 15th registered.
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →5 of the 18 studies in Anxiety Disorders by University of Miami are open now, in 1 country. Each count lists the studies.
Of the 943 Anxiety Disorders studies recruiting now, 416 (44%) set no upper age limit and 460 (49%) stop at 75 or younger; 232 take children under 18; 316 take healthy volunteers.
This study: 7 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →18 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2023.
Median enrollment 80 across the 17 interventional studies, 1,008 across the 1 observational. Of the 12 that completed or were terminated, 2 (17%) have results posted.
University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.
Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.
4 of the studies in Anxiety Disorders by University of Miami that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04729504University of MiamiCultural Adaptation of a SSI for Youth Anxiety | 2026-12-21 |
| NCT06506435University of MiamiRadiotherapy Patient Education With Virtual Reality | 2026-12-31 |
| NCT07437469University of MiamiBinaural Beats for Postoperative Pain and Anxiety Reduction | 2027-01-31 |
| NCT03870360University of MiamiPreventing Anxiety and Depression in Older Hispanics | 2027-06-01 |
Among the 18 studies in Anxiety Disorders by University of Miami, from their registry updates:
The purpose of this study is to administer the Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) and Adolescents (UP-A) to youth and participants' parents and to examine the efficacy and outcomes of the treatment using standardized measures, questionnaires, interviews. The UP-C and the UP-A are cognitive-behavioral therapies to treat emotional disorders.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The participants in this group will receive the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) in up to 15 sessions through a group format, attended over up to 24 weeks. Sessions will include parent and child strategies to manage strong emotions.
Behavioral: The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children
The participants in this group will receive the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) in an individual format for up to 24 weeks.
Behavioral: The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents
The UP-C is administered in-person to parents and children over the course of up to 15 weekly group sessions, which last approximately 90 minutes each.
Also known as: UP-C
The UP-A is administered to parents and teens over the course of approximately 15-24 weekly individual sessions, which last approximately 50 minutes each. Sessions can be administered in-person or online, with at least one session occurring in person.
Also known as: UP-A
Change in Revised Children's Anxiety and Depression Scale - Parent Revised Short Version (RCADS-P-S)
The Change in Revised Children's Anxiety and Depression Scale - Parent Revised Short Version (RCADS-P-25) is 25-item parent-reported scale measuring symptoms of anxiety and depression in youth. Items are rated on a 4-point scale from 1 (Never) to 4 (always) with total composite score ranging from 0 to 75. A score of 70 or higher indicates high severity.
Time frame: Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).
Change in Revised Children's Anxiety and Depression Scale - Child Revised Short Version (RCADS-C-S)
The Change in Revised Children's Anxiety and Depression Scale - Child Revised Short Version (RCADS-25) is 25-item self-reported scale measuring symptoms of anxiety and depression in youth. Items are rated on a 4-point scale from 1 (Never) to 4 (always) with total composite scores ranging from 0 to 75. A score of 70 or higher indicates high severity.
Time frame: Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).
Change in Strengths and Difficulties Questionnaire - Parent Version (SDQ-P)
The Strengths and Difficulties Questionnaire (SDQ) is a 25-item parent-reported measure assessing five domains in youth: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and pro-social behaviors. All items are rated on a 3-point scale from 0 (not true) to 2 (Certainly true). A score can be generated for each scale and all except the prosocial subscale are added together to generate a total composite difficulties score (based on 20 items). Higher total scores are indicative of more problems for all subscales, except for the prosocial scale, where higher scores correspond to fewer difficulties in prosocial behavior.
Time frame: Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).
Change in Strengths and Difficulties Questionnaire - Child Version (SDQ-C)
The Strengths and Difficulties Questionnaire (SDQ) is a 25-item self-reported measure assessing five domains in youth: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and pro-social behaviors. All items are rated on a 3-point scale from 0 (not true) to 2 (Certainly true). A score can be generated for each scale and all except the prosocial subscale are added together to generate a total composite difficulties score (based on 20 items). Higher total composite scores are indicative of more problems for all subscales, except for the prosocial scale, where higher scores correspond to fewer difficulties in prosocial behavior.
Time frame: Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).
Change in Parental Stress Scale (PSS) as measured by Likert Scale
The Parental Stress Scale (PSS) is an 18-item measure assessing parents' feelings about their parenting role, exploring both positive (e.g., emotional benefits, personal development) and negative (e.g., demands on resources, feelings of stress) aspects on parenthood. All items are rated on 5-point Likert scale from 1 (Strongly disagree) to 5 (Strongly agree). Items are summed with higher scores indicating higher levels of parental stress.
Time frame: Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).
Top Problems Assessment - Parent Report as measured by Likert Scale
The Top Problems assessment is used to identify parent-reported target problems for treatment and track changes in problem severity over time. Identified top problem statements are rated on 9-point Likert scale from 0 (not at all a problem) to 8 (a huge problem).
Time frame: up to 24 weeks
Top Problems Assessment - Child Report as measured by Likert Scale
The Top Problems assessment is used to identify self-reported target problems for treatment and track changes in problem severity over time. Identified top problem statements are rated on 9-point Likert scale from 0 (not at all a problem) to 8 (a huge problem).
Time frame: up to 24 weeks
Change in Clinical Global Impression, Severity Scale (CGI-S)
The CGI-S is a single-item clinician-reported measure used to assess the severity of the youth's illness at the time of assessment. The item is rated on a 7-point scale ranging from 1 (very much improved since the initiation of treatment) to 7 (very much worse since the initiation of treatment). Higher scores indicate greater symptom severity.
Time frame: At baseline, and up to 24 weeks
Clinical Global Impression - Improvement (CGI-I)
The CGI-I is a single-item clinician-reported measure used to assess clinical changes in youth symptomology over the course of treatment. The item is rated on a 7-point scale ranging from 1 (very much improved since the initiation of treatment) to 7 (very much worse since the initiation of treatment). Higher scores indicate greater symptom improvement since baseline.
Time frame: At up to 24 weeks
Plan to share: No
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