Parent Management Training to Treat Irritability

Not Applicable

Recruiting

• Conditions: Irritable Mood; Anger; Temper Tantrum
• Interventions: Behavioral: Parent Management Training

• Registration Number: NCT06020261
• Lead Sponsor: University of Colorado, Denver

Brief Summary

This is a pilot study to determine if the investigator can accrue a diverse sample of 18 children with significant irritability, conduct manualized Parent Management Training (PMT) with this group and measure physiology during a frustration task pre- and post- PMT sessions. 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

Up to 18 participants will be consented for this Parent Management Training (PMT) to Treat Irritability study in order to meet the aim of having 12 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.

Study Timeline

• Study First Submitted: 2023-08-25
• Study First Submitted QC: 2023-08-25
• Study First Posted: 2023-08-31
• Status Verified: 2024-12
• Study Start: 2024-12-01
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-05
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Parent Management Training	Parent Management Training	12 sessions of manualized Parent Management Training.

Primary Outcome Measures

Name	Time	Method
recruitment feasibility	one year	The number of participants completing 12 sessions of PMT in one year will be at least 30.

Secondary Outcome Measures

Name	Time	Method
reduction in irritability	12 weeks	Participants will report a decrease in irritability as measured by the ARI.

Trial Locations

Locations (1)

Childrens Hospital Colorado; 🇺🇸 Aurora, Colorado, United States