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Behavioral Intervention

Parent Management Training for Irritability (PMT Trial)

N/A
Recruiting
Led By Joel Stoddard, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if they can enroll 30 children with significant irritability, provide Parent Management Training (PMT), and measure their physiology before and after the training. They want to show that

Who is the study for?
This trial is for children with significant irritability, who often have temper tantrums or show anger. To join, a child must score 3 or higher on the Clinician Affective Reactivity Index and have a parent or guardian willing to participate in therapy sessions with them.
What is being tested?
The study is testing Parent Management Training (PMT) as a way to help manage children's irritability. It involves measuring changes in behavior and physiology before and after PMT to see if it's effective.
What are the potential side effects?
Since this trial focuses on behavioral training rather than medication, there are no direct medical side effects. However, participating families may experience stress or emotional discomfort during therapy sessions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
recruitment feasibility
Secondary study objectives
reduction in irritability

Side effects data

From 2014 Phase 4 trial • 11 Patients • NCT02048241
50%
Fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intuniv Plus Parent Management Training
Placebo Plus Parent Management Training

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Parent Management TrainingExperimental Treatment1 Intervention
12 sessions of manualized Parent Management Training.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Parent Management Training
2011
Completed Phase 4
~160

Find a Location

Who is running the clinical trial?

Childrens Hospital ColoradoUNKNOWN
University of Colorado, DenverLead Sponsor
1,810 Previous Clinical Trials
2,920,064 Total Patients Enrolled
Children's Hospital ColoradoOTHER
120 Previous Clinical Trials
5,133,155 Total Patients Enrolled
Joel Stoddard, MDPrincipal InvestigatorUniversity of Colorado Denver Anschutz
1 Previous Clinical Trials
97 Total Patients Enrolled
~24 spots leftby May 2025
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