Parent Management Training to Treat Irritability

NCT ID: NCT06020261

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-12

Study Completion Date

2026-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Irritable Mood Temper Tantrum Anger

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Parent Management Training

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

Group Type EXPERIMENTAL

Parent Management Training

Intervention Type BEHAVIORAL

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

Interventions

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Parent Management Training

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

Intervention Type BEHAVIORAL

Other Intervention Names

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behavioral treatment

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joel Stoddard, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado Denver, Anschutz Medical Campus

Joel Stoddard, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado Denver Anschutz

Locations

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Childrens Hospital Colorado

Aurora, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jami Moe-Hartman, MA

Role: CONTACT

303-724-2259

Jessica Hawks, PhD

Role: CONTACT

720-777-8214

Facility Contacts

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Jessica Hawks, PhD

Role: primary

720-777-8221

Other Identifiers

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23-0065

Identifier Type: -

Identifier Source: org_study_id

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