Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2026-01-21 @ 3:56 PM
Study NCT ID:
NCT06020261
Status:
RECRUITING
Last Update Posted:
2025-04-30
First Post:
2023-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parent Management Training to Treat Irritability
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
The Efficacy of Parent Management Training to Treat Irritability
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PMT
Brief Summary:
The goal of this clinical trial is to see if 12 sessions of a Parent Management Training program can treat irritability in children aged 10-14 years old. The main question it aims to answer are:
* Can a Parent Management Training for parents reduce anger outbursts and cranky moods in their children?
* Can Parent Management Training be done in an outpatient clinic and do parents like it?
Up to 18 families can join this study. This study will be used to set up a larger study in the Fall of 2025.
Parent participants will complete 12 sessions of Parent Management Training for Irritability. Each session will be 45-55 minutes weekly. They will also participate in the assessments of their child before, during and after treatment.
Child participants will do assessments before, during and after the Parent Management Training treatment.
* Can a Parent Management Training for parents reduce anger outbursts and cranky moods in their children?
* Can Parent Management Training be done in an outpatient clinic and do parents like it?
Up to 18 families can join this study. This study will be used to set up a larger study in the Fall of 2025.
Parent participants will complete 12 sessions of Parent Management Training for Irritability. Each session will be 45-55 minutes weekly. They will also participate in the assessments of their child before, during and after treatment.
Child participants will do assessments before, during and after the Parent Management Training treatment.
Detailed Description:
Up to 18 families will be consented for this Parent Management Training (PMT) to Treat Irritability study in order to meet the aim of having 12 families complete the study. The child and a parent will complete pre-treatment evaluations about the child's 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 the 12 PMT sessions from a licensed mental health professional. The PMT sessions will focus on the parents only, but both the parent and child will complete standardized measures and interview with a clinician in the middle of the treatment. After the 12 sessions of PMT, the parent and child will complete a post-treatment assessment. Pre and post treatments assessments will be compared to determine changes in the child's irritability and other areas of functioning.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: