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Clinical Trial Summary

This is a pilot study to determine if the investigator can accrue a diverse sample of 30 children with significant irritability, conduct manualized Parent Management Training (PMT) with this group and measure physiology during pre- and post- PMT visits. The investigator will also aim to demonstrate the initial efficacy of PMT for irritability and utilize this trial to serve as a standard of care comparison for future studies.


Clinical Trial Description

Up to 45 participants will be consented for this Parent Management Training (PMT) to Treat Irritability study in order to meet the aim of having 30 participants complete the study. The child participant and a parent will complete a pre-treatment study visit to evaluate mental health, behavior and cognitive functioning. Participants who meet inclusion criteria (age 10-14 with significant irritability) and do not meet exclusion criteria (e.g. Autism, Bipolar disorder, active PTSD, serious medical issues or Intellectual disability) will be invited to join the trial. All participants will receive an active treatment of 12 PMT sessions from a licensed or license eligible clinician supervised by a licensed clinician. These session will focus on the parents only, but both the parent and child will complete standardized measures during treatment. After the 12 sessions of PMT, the parent and child will complete a post-treatment visit to complete measures. Pre and post treatment measures will be compared to determine improvement in irritability as well as other areas of functioning. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06020261
Study type Interventional
Source University of Colorado, Denver
Contact Jami Moe-Hartman, MA
Phone 303-724-2259
Email jami.moehartman@cuanschutz.edu
Status Not yet recruiting
Phase N/A
Start date December 15, 2023
Completion date December 2024

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