Parent Management Training to Treat Irritability (PMT)

The Efficacy of Parent Management Training to Treat Irritability

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.

Study Overview

• Status: Recruiting
• Conditions: Anger; Irritable Mood; Temper Tantrum
• Intervention / Treatment: Behavioral: Parent Management Training

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 Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jami Moe-Hartman, MA; Phone Number: 303-724-2259; Email: jami.moehartman@cuanschutz.edu
• Study Contact Backup: Name: Jessica Hawks, PhD; Phone Number: 720-777-8214; Email: jessica.hawks@childrenscolorado.org

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Childrens Hospital Colorado
      • Contact: Jessica Hawks, PhD; Phone Number: 720-777-8221; Email: jessica.hawks@childrenscolorado.org
      • Principal Investigator: Joel Stoddard, MAS, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• clinically significant irritability (Clinician Affective Reactivity Index 30 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 Post-Traumatic Stress Disorder (PTSD) or a severe active stressor (e.g. child abuse)
• 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 Wechsler Abbreviated Scale of Intelligence Second Edition (WASI II) estimated Intelligence Quotient (IQ)<70.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parent Management Training; 12 sessions of manualized Parent Management Training for irritability developed by the National Institute of Mental Health.	Behavioral: Parent Management Training; developing parenting skills and competencies dealing with oppositional and irritable behaviors in the child.; Other Names: behavioral treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demonstrate the feasibility of Parent Management Training (PMT) procedures	The study team will implement a PMT protocol with fidelity and acceptability assessments. A member of the study team will complete independent fidelity ratings of 50% of recorded sessions using the Cognitive Behavior Therapy for Irritability Adherence Scale. The Working Alliance Inventory (WAI) (revised short form) will be used by the clinician and the parent to rate engagement in treatment after each PMT session. There are no established benchmarks for this measure, but it will provide information about the acceptability of the treatment by rating the alliance between the therapist and the parent.	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in irritability	Participants will report a decrease in irritability as measured by the Revised Affective Reactivity Index-Clinician (ARI-CL). The ARI-CL rates temper outbursts, irritable moods and impairment. Total scores range from 0-50, with a score over 30 indicating severe clinical irritability and lower scores indicating lower irritability.	5 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Childrens Hospital Colorado
• Investigators: Principal Investigator: Joel Stoddard, MD, University of Colorado Denver, Anschutz Medical Campus; Principal Investigator: Joel Stoddard, MD, University of Colorado Denver Anschutz

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: August 25, 2023
• First Posted (Actual): August 31, 2023

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: irritability; parenting; anger; temper outbursts; Parent Management Training
• Additional Relevant MeSH Terms: Psychotherapy; Behavioral Disciplines and Activities; Behavior Therapy
• Other Study ID Numbers: 23-0065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No