CLS-R-FUERTE for Defiant Disorder, Oppositional

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UCSF, San Francisco, CA
Defiant Disorder, Oppositional+2 More
CLS-R-FUERTE - Behavioral
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a remote training program for school clinicians to see if it's more effective than usual care for treating ADHD/ODD in Mexican youth. CLS-R-FUERTE is used to treat Defiant Disorder, Oppositional. The treatment can be done online. There will be no placebo group in this trial. CLS-R-FUERTE has previously been approved by the FDA for a different condition.

Eligible Conditions

  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Defiant Disorder, Oppositional

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 0 Secondary · Reporting Duration: Baseline and post treatment (8 weeks)

Week 8
Change Impairment Rating Scale (IRS) Parent Questionnaire Overall Severity Score
Change Impairment Rating Scale (IRS) Teacher Questionnaire Overall Severity Score
Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score
Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist ADHD Combined type Symptom Severity Score
Change in Child Symptom Inventory-4 (CSI-4) Teacher Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score
Change in Child Symptom Inventory-4 (CSI-4) Teacher Checklist ADHD Combined type Symptom Severity Score

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Care-As-Usual
1 of 2
CLS-R-FUERTE
1 of 2
Active Control
Experimental Treatment

200 Total Participants · 2 Treatment Groups

Primary Treatment: CLS-R-FUERTE · No Placebo Group · N/A

CLS-R-FUERTE
Behavioral
Experimental Group · 1 Intervention: CLS-R-FUERTE · Intervention Types: Behavioral
Care-As-UsualNoIntervention Group · 1 Intervention: Care-As-Usual · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and post treatment (8 weeks)
Closest Location: UCSF · San Francisco, CA
Photo of San Francisco 1Photo of San Francisco 2Photo of San Francisco 3
2009First Recorded Clinical Trial
2 TrialsResearching Defiant Disorder, Oppositional
93 CompletedClinical Trials

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,246 Previous Clinical Trials
11,472,940 Total Patients Enrolled
1 Trials studying Defiant Disorder, Oppositional
69 Patients Enrolled for Defiant Disorder, Oppositional
National Institute of Mental Health (NIMH)NIH
2,492 Previous Clinical Trials
1,766,215 Total Patients Enrolled
13 Trials studying Defiant Disorder, Oppositional
3,577 Patients Enrolled for Defiant Disorder, Oppositional
Lauren M Haack, PhDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
69 Total Patients Enrolled
1 Trials studying Defiant Disorder, Oppositional
69 Patients Enrolled for Defiant Disorder, Oppositional

Eligibility Criteria

Age Any Age · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have at least six inattention symptoms and/or six hyperactive/impulsive symptoms.
Students taking medication are eligible as long as regimens were stable.
Parents and teachers and school clinicians of participating are eligible to participate.
You have at least one area of impairment rated as concerning by both parent and teacher.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.