Irritable MoodPMTNCT06020261
Parent Management Training to Treat Irritability
A study testing Parent Management Training in people with Irritable Mood and Temper Tantrum, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Irritable Mood, Temper Tantrum, Anger
- What is being tested?
- Parent Management Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Childrens Hospital Colorado
Aurora, Colorado, 80045
Jessica Hawks, PhD, 720-777-8221, jessica.hawks@childrenscolorado.org
Joel Stoddard, MAS, MD
About this study
Official title: The Efficacy of Parent Management Training to Treat Irritability
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?
Read more
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.
Read the detailed description
Up to 24 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.
- Conditions
- Irritable Mood, Temper Tantrum, Anger
- Being tested
- Parent Management Training
- Keywords
- irritability, anger, parenting, temper outbursts, Parent Management Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Management TrainingBehavioural
Also called behavioral treatment
developing parenting skills and competencies dealing with oppositional and irritable behaviors in the child.
| Study group | Role | What they receive |
|---|---|---|
| Parent Management Training | Experimental | 12 sessions of manualized Parent Management Training for irritability developed by the National Institute of Mental Health. Receives: Behavioral: Parent Management Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Secondary outcomes (1)
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start12 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable MoodStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Colorado
- Responsible party
- Sponsor
- Investigators
- Joel Stoddard, MD, Principal investigator, University of Colorado Denver, Anschutz Medical CampusJoel Stoddard, MD, Principal investigator, University of Colorado Denver Anschutz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020261
- Sponsor's protocol ID
- 23-0065
- Acronym
- PMT
- Status last verified
- Jul 2026
- First submitted
- 25 Aug 2023
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Parent Management Training to Treat Irritability
- ClinicalTrials.gov ID
- NCT06020261
- Acronym / sponsor ID
- PMT / 23-0065
- Conditions
- Irritable Mood, Temper Tantrum, Anger
- Keywords
- irritability, anger, parenting, temper outbursts, Parent Management Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Children's Hospital Colorado
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Up to 24 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Parent Management Training | Experimental | Behavioral: Parent Management Training12 sessions of manualized Parent Management Training for irritability developed by the National Institute of Mental Health. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent Management TrainingAlso: behavioral treatmentdeveloping parenting skills and competencies dealing with oppositional and irritable behaviors in the child. | Behavioural | Parent Management Training |
Primary outcome
Demonstrate the feasibility of Parent Management Training (PMT) procedures
Time frame: 5 months
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.
1 secondary outcome
Change in irritability
Time frame: 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joel Stoddard, MD principal investigator
University of Colorado Denver, Anschutz Medical Campus
Joel Stoddard, MD principal investigator
University of Colorado Denver Anschutz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Management Training in people with Irritable Mood and Temper Tantrum, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jami Moe-Hartman, MA (303-724-2259, jami.moehartman@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate the feasibility of Parent Management Training (PMT) procedures (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.