Parent Management Training to Treat Irritability

ConditionsIrritable Mood Temper Tantrum Anger

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age10-14

SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

36 Participants

are divided into 1 treatment group

Group A: Parent Management TrainingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Demonstrate the feasibility of Parent Management Training (PMT) procedures

The study team will implement a PMT protocol with fidelity and acceptability assessments. The Working Alliance Inventory (WAI) (revised short form) will be used by the clinician and the parent to rate engagement in treatment after each PMT session. There are no established benchmarks for this measure, but it will provide information about the acceptability of the treatment by rating the alliance between the therapist and the parent.

Time frame

5 months

Secondary outcomes

Change in irritability

Participants will report a decrease in irritability as measured by the Revised Affective Reactivity Index-Clinician (ARI-CL). The ARI-CL rates temper outbursts, irritable moods and impairment. Total scores range from 0-50, with a score over 30 indicating severe clinical irritability and lower scores indicating lower irritability.

Time frame

5 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

Children's Hospital Colorado

Collaborator

Source ClinicalTrials.gov

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