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Behavioral Intervention

Cognitive Behavioral Therapy for Mental Health Issues in Youth

N/A

Recruiting

Led By Jill Ehrenreich-May, PhD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children and their parents must be able to speak and understand English and/or Spanish sufficiently well to complete study procedures (e.g., provide their informed consent/assent, complete assessment measures and/or program materials)

Children between the ages of 7-17

Timeline

Screening 3 weeks

Treatment Varies

Follow Up session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).

Awards & highlights

Study Summary

This trial tests a cognitive-behavioral therapy to treat emotional disorders in youth & their parents, evaluating results with standardized measures.

Who is the study for?

This trial is for children aged 7-17 with anxiety, depression, or similar emotional disorders who live in Miami-Dade County. They must speak English/Spanish and have a parent to participate in all sessions. Excluded are those prioritizing other issues like eating disorders or substance abuse, or who've had psychiatric hospitalization recently.Check my eligibility

What is being tested?

The study tests the Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) and Adolescents (UP-A). These cognitive-behavioral therapies aim to treat various emotional disorders through standardized measures and interviews.See study design

What are the potential side effects?

While specific side effects aren't listed for these interventions, therapy can sometimes bring up uncomfortable emotions or reactions as part of the treatment process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child and I can speak and understand English or Spanish well enough for study procedures.

Select...

I am between 7 and 17 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).

This trial's timeline: 3 weeks for screening, Varies for treatment, and session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Parental Stress Scale (PSS) as measured by Likert Scale

Change in Revised Children's Anxiety and Depression Scale - Child Revised Short Version (RCADS-C-S)

Change in Revised Children's Anxiety and Depression Scale - Parent Revised Short Version (RCADS-P-S)

+2 more

Secondary outcome measures

Change in Clinical Global Impression, Severity Scale (CGI-S)

Clinical Global Impression - Improvement (CGI-I)

Top Problems Assessment - Child Report as measured by Likert Scale

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in ChildrenExperimental Treatment1 Intervention

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.

Group II: The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in AdolescentsExperimental Treatment1 Intervention

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Children's Trust, Miami FLOTHER

5 Previous Clinical Trials

1,105 Total Patients Enrolled

1 Trials studying Parenting

300 Patients Enrolled for Parenting

University of MiamiLead Sponsor

902 Previous Clinical Trials

408,576 Total Patients Enrolled

2 Trials studying Parenting

350 Patients Enrolled for Parenting

The Children's TrustUNKNOWN

4 Previous Clinical Trials

1,005 Total Patients Enrolled

1 Trials studying Parenting

300 Patients Enrolled for Parenting

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the target population for this trial limited to individuals over 20 years of age?

"This medical research is attempting to enrol young individuals between seven and seventeen years old."

Answered by AI

Do I satisfy the qualifications to be involved in this medical experiment?

"This trial seeks 1500 patients with depression in the 7-17 age range. To qualify, applicants must fulfill both of these criteria."

Answered by AI

Are there any vacancies in this clinical trial that could accommodate more participants?

"According to the clinicaltrials.gov website, this experiment is still recruiting - it was first advertised on September 25th 2023 and its information has been most recently updated on September 18th of the same year."

Answered by AI

What is the upper limit of participants for this experiment?

"Affirmative, the entry on clinicaltrials.gov confirms that this research study is actively looking for participants. As of September 18th 2023, 1500 individuals must be enrolled from one medical facility; the trial was first posted on 25th September 2023."

Answered by AI

What key goals are this research endeavor aiming to accomplish?

"This trial will track progress through three distinct sessions - Session 1 (roughly one week), Session 8 (around the eighth week) and a natural termination session after 24 weeks. The primary outcome measure being tracked is Change in Revised Children's Anxiety and Depression Scale - Child Revised Short Version (RCADS-C-S). Additionally, investigators are monitoring Top Problems Assessment - Child Report via Likert Scales, Clinical Global Impression Severity Scores (CGI-S), as well as gauging improvements with Clinical Global Impression Improvement ratings (CGII)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Unified Protocol: Community Connections

Jill May Ehrenreich 2023. "Unified Protocol: Community Connections". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06038721.

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