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NCT Number: NCT06020261

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 24 families can join this study.

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.

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Key information

Age range

10 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Childrens Hospital Colorado

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Jessica Hawks, PhD

CONTACT

[email protected]

720-777-8221

Joel Stoddard, MAS, MD

PRINCIPAL_INVESTIGATOR

About this study

Up to 24 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • clinically significant irritability (Clinician Affective Reactivity Index 30 or greater)
  • parent or guardian with whom the child resides for at least 50% of the time is 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.

Treatment and study plan

Parent Management Training

Behavioral

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

Other names: behavioral treatment

Primary outcomes

  1. Demonstrate the feasibility of Parent Management Training (PMT) procedures

    Time frame: 5 months

    The study team will implement a PMT protocol with fidelity and acceptability assessments. 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.

Secondary outcomes

  1. Change in irritability

    Time frame: 5 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jami Moe-Hartman, MA

CONTACT

[email protected]

303-724-2259

Jessica Hawks, PhD

CONTACT

[email protected]

720-777-8214

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Children's Hospital Colorado

Registry information

Official study title

The Efficacy of Parent Management Training to Treat Irritability

Acronym: PMT

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 31, 2023
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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