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Recruiting NCT06020261

Parent Management Training to Treat Irritability

No phase Interventional Irritable Mood Temper Tantrum Anger

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Parent Management Training.
Who it may be relevant to
Registry conditions: Irritable Mood, Temper Tantrum, Anger. Basic parameters: 10 years — 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Efficacy of Parent Management Training to Treat Irritability

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Demonstrate the feasibility of Parent Management Training (PMT) procedures [Time frame: 5 months]
Secondary outcome measures (1)
  • Change in irritability [Time frame: 5 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Childrens Hospital Colorado — Aurora

Identifiers

NCT: NCT06020261 · 23-0065

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗