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PMT: Parent Management Training to Treat Irritability

Sponsor
University of Colorado, Denver (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06020261
Collaborator
Children's Hospital Colorado (Other), National Institute of Mental Health (NIMH) (NIH)
45
Enrollment
1
Arm
11
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Parent Management Training
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
pre assessment, 12 sessions of manualized Parent Management Training, post assessmentpre assessment, 12 sessions of manualized Parent Management Training, post assessment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Parent Management Training to Treat Irritability
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Parent Management Training

12 sessions of manualized Parent Management Training.

Behavioral: Parent Management Training
developing parenting skills and competencies dealing with oppositional and irritable behaviors in the child.
Other Names:
  • behavioral treatment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. recruitment feasibility [one year]

      meet recruitment target of n=30 participants completing PMT

    Secondary Outcome Measures

    1. reduction in irritability [12 weeks]

      examine whether there is a reduction in irritability as measured by the Clinician ARI after completion of PMT

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 14 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Colorado, Denver
    • Children's Hospital Colorado
    • National Institute of Mental Health (NIMH)

    Investigators

    • Principal Investigator: Joel Stoddard, MD, University of Colorado Denver, Anschutz Medical Campus

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT06020261
    Other Study ID Numbers:
    • 23-0065
    First Posted:
    Aug 31, 2023
    Last Update Posted:
    Aug 31, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Colorado, Denver
    Parent management
    irritability
    anger

    Study Results

    No Results Posted as of Aug 31, 2023