Parent Management Training to Treat Irritability

Study Overview
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Brief Summary
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This is a pilot study to determine if the investigator can accrue a diverse sample of 30 children with significant irritability, conduct manualized Parent Management Training (PMT) with this group and measure physiology during pre- and post- PMT visits. The investigator will also aim to demonstrate the initial efficacy of PMT for irritability and utilize this trial to serve as a standard of care comparison for future studies.

Detailed Description
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Up to 45 participants will be consented for this Parent Management Training (PMT) to Treat Irritability study in order to meet the aim of having 30 participants complete the study. The child participant and a parent will complete a pre-treatment study visit to evaluate 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 an active treatment of 12 PMT sessions from a licensed or license eligible clinician supervised by a licensed clinician. These session will focus on the parents only, but both the parent and child will complete standardized measures during treatment. After the 12 sessions of PMT, the parent and child will complete a post-treatment visit to complete measures. Pre and post treatment measures will be compared to determine improvement in irritability as well as other areas of functioning.

Official Title
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Parent Management Training to Treat Irritability

Conditions
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Irritable Mood, Temper Tantrum, Anger

Intervention / Treatment
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* Behavioral: Parent Management Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinically significant irritability (Clinician Affective Reactivity Index 3 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 PTSD or a severe active stressor (e.g. child maltreatment) 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 WASI II estimated IQ<70.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: pre assessment, 12 sessions of manualized Parent Management Training, post assessment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parent Management Training<br>12 sessions of manualized Parent Management Training. | Behavioral: Parent Management Training<br>* developing parenting skills and competencies dealing with oppositional and irritable behaviors in the child.<br>* Other names: behavioral treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recruitment feasibility | The number of participants completing 12 sessions of PMT in one year will be at least 30. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in irritability | Participants will report a decrease in irritability as measured by the ARI. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parent management, irritability, anger