Clinical trial NCT06020261: Parent Management Training to Treat Irritability
Official title: The Efficacy of Parent Management Training to Treat Irritability
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Irritable Mood
Temper Tantrum
Anger
Keywords: irritability
anger
parenting
temper outbursts
Parent Management Training
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 36
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Demonstrate the feasibility of Parent Management Training (PMT) procedures
timeFrame: 5 months
Secondary outcomes:
measure: Change in irritability
timeFrame: 5 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Childrens Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado Denver, Anschutz Medical Campus
name: Joel Stoddard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado Denver Anschutz
name: Joel Stoddard, MD
role: PRINCIPAL_INVESTIGATOR
References: