Parent Management Training to Treat Irritability

NCT06020261 | Recruiting

• 1 other identifier: 23-0065
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Mood; Temper Tantrum; Anger

Keywords

irritability; anger; parenting; temper outbursts; Parent Management Training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in irritability

  5 months

Study Arms (1)

Parent Management Training

EXPERIMENTAL

12 sessions of manualized Parent Management Training for irritability developed by the National Institute of Mental Health.

Behavioral: Parent Management Training

Interventions

Parent Management Training BEHAVIORAL

developing parenting skills and competencies dealing with oppositional and irritable behaviors in the child.

Also known as: behavioral treatment

Parent Management Training

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• clinically significant irritability (Clinician Affective Reactivity Index 30 or greater)
• parent or guardian willing to participate in treatment with the child

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Childrens Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Interventions

Behavior Therapy

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Joel Stoddard, MD

  University of Colorado Denver, Anschutz Medical Campus

  PRINCIPAL INVESTIGATOR

• Joel Stoddard, MD

  University of Colorado Denver Anschutz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jami Moe-Hartman, MA

CONTACT

303-724-2259; jami.moehartman@cuanschutz.edu

Jessica Hawks, PhD

CONTACT

720-777-8214; jessica.hawks@childrenscolorado.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive 12 sessions of Parent Management Training to treat irritability. Participant children and their parents will complete pre-treatment, mid treatment, and post-treatment assessments to determine if there is any improvement in irritability or other areas of functioning.

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 31, 2023
• Study Start: June 12, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)