Parent Management Training to Treat Irritability

Anger Clinical Trial

— PMT  

Official title:

Parent Management Training to Treat Irritability

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06020261
• Other study ID #: 23-0065
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: University of Colorado, Denver
• Contact: Jami Moe-Hartman, MA
• Phone: 303-724-2259
• Email: jami.moehartman[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 14 Years

Eligibility

Inclusion Criteria:

• clinically significant irritability (Clinician Affective Reactivity Index 3 or greater)

• parent or guardian willing to participate in treatment with the child

Exclusion Criteria:

• psychiatric instability (danger to self/others, risky substance abuse)

• current active PTSD or a severe active stressor (e.g. child maltreatment)

• history of severe psychopathology with an established alternate treatment (e.g. autism spectrum disorder, bipolar disorder, schizophrenia, intellectual disability)

• general medical condition that may be driving irritability or prevent generalizable physiologic measures.

• screen positive for an intellectual disability via WASI II estimated IQ<70.

Related Conditions & MeSH terms

• Anger
• Irritable Mood

Intervention

Behavioral:
• Parent Management Training
developing parenting skills and competencies dealing with oppositional and irritable behaviors in the child.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Children's Hospital Colorado

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recruitment feasibility	The number of participants completing 12 sessions of PMT in one year will be at least 30.	one year
Secondary	reduction in irritability	Participants will report a decrease in irritability as measured by the ARI.	12 weeks