Parent Management Training for Irritability

(PMT Trial)

Overseen By Jessica Hawks, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Psychiatric instability, PTSD, Autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 14

Duration: 12 weeks

36 Participants Needed

Trial Summary

What is the purpose of 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 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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Parent Management Training for irritability?

Research shows that Parent Management Training (PMT) is effective in reducing problem behaviors like aggression and defiance in children, improving parenting skills, and decreasing parent stress. Studies have demonstrated significant improvements in children's behavior and family dynamics, suggesting that PMT can lead to positive changes in managing irritability. ^{1 2 3 4 5}

Is Parent Management Training safe for use in humans?

Research on Parent Management Training, including digital versions like the 'Tantrum Tool,' shows high satisfaction and retention rates among participants, suggesting it is generally safe for use in humans. ^{5 6 7 8 9}

How is Parent Management Training different from other treatments for irritability?

Parent Management Training is unique because it focuses on teaching parents specific skills to manage their child's behavior, which can improve both the child's and the parent's behavior. Unlike some treatments that may involve medication or direct therapy with the child, this approach empowers parents to create a positive change in their child's environment and behavior through structured guidance and support. ^{1 10 11 12 13}

Research Team

Joel Stoddard, MD

Principal Investigator

University of Colorado Denver Anschutz

Eligibility Criteria

This trial is for children with significant irritability, who often have temper tantrums or show anger. To join, a child must score 3 or higher on the Clinician Affective Reactivity Index and have a parent or guardian willing to participate in therapy sessions with them.

Inclusion Criteria

You demonstrate a clinically meaningful level of irritability.

Consent of a parent or guardian to take part in the child's treatment is required.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive 12 sessions of manualized Parent Management Training (PMT) focusing on parents, with pre- and post-treatment measures

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with comparison of pre- and post-treatment measures

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Parent Management Training

Trial Overview The study is testing Parent Management Training (PMT) as a way to help manage children's irritability. It involves measuring changes in behavior and physiology before and after PMT to see if it's effective.

Participant Groups

Group I: Parent Management Training Experimental Treatment 1 Intervention

12 sessions of manualized Parent Management Training for irritability developed by the National Institute of Mental Health.

Parent Management Training is already approved in United States, European Union for the following indications:

Approved in United States as Parent Management Training for:

• Irritability in children with ADHD and other emotional and behavioral disorders

Approved in European Union as Parent Management Training for:

• Disruptive behavior disorders in children
• ADHD
• Anxiety with behavioral difficulties

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Childrens Hospital Colorado

Collaborator

Trials

1

Recruited

40+

Children's Hospital Colorado

Collaborator

Trials

121

Recruited

5,135,000+

Findings from Research

Group parent training significantly improved parenting behaviors and reduced hyperactive, defiant, and aggressive behaviors in 45 children with ADHD, demonstrating its efficacy in managing these issues.

The training also helped reduce parent stress, indicating that effective parent training programs can benefit both parents and children in a group setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The outcome of group parent training for families of children with attention-deficit hyperactivity disorder and defiant/aggressive behavior. Danforth, JS., Harvey, E., Ulaszek, WR., et al.[2019]

Parent Management Training (PMT) significantly improved problem behaviors and social competence in children with oppositional and aggressive behaviors, with 138 families participating in the study.

Both the standard and enhanced versions of PMT showed similar positive outcomes for children and parents, indicating that the enhancements did not provide additional benefits beyond the standard PMT approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent management training for conduct problems in children: Enhancing treatment to improve therapeutic change. Kazdin, AE., Glick, A., Pope, J., et al.[2020]

In an effectiveness trial of parent management training as part of the Prevention Program for Externalizing Problem Behavior (PEP), a significant percentage of children (32.6% to 60.7%) were identified as having clinically relevant externalizing behavior issues at the start of the study.

After three months of treatment, between 24.8% and 60.4% of these children showed recovery, indicating that parent management training can lead to meaningful improvements in managing externalizing behavior problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does parent management training for children with externalizing problem behavior in routine care result in clinically significant changes? Hautmann, C., Stein, P., Hanisch, C., et al.[2015]

An intensive 2-week behavior treatment program for 12 children, focusing on increasing frustration tolerance, was effective in reducing behavior problems, showing large effect sizes (Cohen's ds of 3.2 and 1.37).

The study suggests that a compressed, function-based intervention is both feasible and acceptable for caregivers, addressing previous concerns about high attrition in traditional Behavioral Parent Training programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of a Compressed Caregiver Training Program to Treat Child Behavior Problems. Edelstein, ML., Sullivan, A., Becraft, JL.[2023]

The Brief Behavioral Intervention, a shorter version of parent management training, effectively reduced disruptive behavior in children aged 2-6.5 years, with significant improvements noted immediately after treatment and maintained at 6-month and 1-year follow-ups.

The study involved 120 children and showed lower attrition rates compared to typical treatment programs, indicating that this brief intervention may be more acceptable and sustainable for families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment effectiveness of a brief behavioral intervention for preschool disruptive behavior. Axelrad, ME., Butler, AM., Dempsey, J., et al.[2021]

The 'Tantrum Tool' digital parent management training program showed high acceptability and feasibility, with 80% of participants completing the 8-week intervention and parents expressing high satisfaction.

Significant reductions in disruptive behavior and irritability were observed, with the Disruptive Behavior Rating Scale scores decreasing from 13.5 to 7.3 and the Affective Reactivity Index irritability scores dropping from 7.2 to 3.75, indicating the program's effectiveness in managing these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tantrum Tool: Development and Open Pilot Study of Online Parent Training for Irritability and Disruptive Behavior. Diaz-Stransky, A., Rowley, S., Zecher, E., et al.[2021]

Parent Management Training (PMT) is a well-researched treatment method for addressing oppositional, aggressive, and antisocial behaviors in children and adolescents, showing significant efficacy in controlled studies.

Despite its proven effectiveness, there are still unanswered questions regarding the long-term impact and overall effectiveness of PMT, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent management training: evidence, outcomes, and issues. Kazdin, AE.[2022]

The 'errorless compliance training' method effectively improved child compliance in two cases of severe defiance, reducing confrontations and the risk of physical abuse between mothers and their children.

By gradually introducing requests with a high likelihood of compliance and reinforcing positive behavior, the approach minimized the need for coercive consequences, showing promise for addressing parenting challenges linked to family violence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Errorless compliance training with physically abusive mothers: a single-case approach. Ducharme, JM., Atkinson, L., Poulton, L.[2019]

A study involving 178 families in Chile demonstrated that a universal parenting training program effectively reduced behavior problems in children aged 3 to 6 by modifying parenting practices.

The reduction in harsh discipline, physical punishment, and parental inconsistency were key factors mediating the improvement in child behavior, highlighting the importance of these practices in parenting interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized cluster trial of a parenting program in Chile: Key mediators in the decrease in behavior problems in preschool children. Cova, F., Rincón, P., Bustos, C., et al.[2022]

A training program for parental educators improved their knowledge and confidence in teaching parenting classes, as evaluated by six staff and parent volunteers from a family resource center.

Parents who attended the 10-week parenting classes led by trained graduates reported significant reductions in verbal and corporal punishment, increased nurturing behaviors, and improved perceptions of their children's behavior, similar to results from classes taught by a university instructor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating a training program for parental educators. Fox, RA., Hennick, EP.[2013]

A systematic review identified 13 key components necessary for developing effective parent management training programs aimed at reducing behavioral problems in preschool children with autism spectrum disorder.

The study emphasizes the need for tailored interventions that consider the unique characteristics of children with autism, suggesting that standard parent management training may require modifications to be effective for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Common elements of parent management training programs for preschool children with autism spectrum disorder. Eskandari, B., Pouretemad, H., Mousavi, M., et al.[2022]

Behavioral parent training and cognitive-behavioral therapy are the recommended first-line interventions for managing severe irritability in youth, which is often linked to various mental health conditions.

The MATCH modular approach effectively combines these strategies, allowing for personalized treatment, and initial evidence suggests it is particularly effective for addressing irritability, although further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Modular, Transdiagnostic Approach to Treating Severe Irritability in Children and Adolescents. Evans, SC., Santucci, L.[2021]

The Brief Behavioral Intervention, a shorter version of traditional parent management training, was effective in addressing behavioral difficulties in young children, with parents reporting improvements after an average of just 7.2 sessions.

This intervention shows promise as a more accessible treatment option for parents of children aged 2-6.5, potentially preventing the escalation of behavior problems without the lengthy commitment of standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief behavioral intervention for young children with disruptive behaviors. Axelrad, ME., Garland, BH., Love, KB.[2021]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

The outcome of group parent training for families of children with attention-deficit hyperactivity disorder and defiant/aggressive behavior. [2019]

2. Spain pubmed.ncbi.nlm.nih.gov

Parent management training for conduct problems in children: Enhancing treatment to improve therapeutic change. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Does parent management training for children with externalizing problem behavior in routine care result in clinically significant changes? [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of a Compressed Caregiver Training Program to Treat Child Behavior Problems. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment effectiveness of a brief behavioral intervention for preschool disruptive behavior. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Tantrum Tool: Development and Open Pilot Study of Online Parent Training for Irritability and Disruptive Behavior. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Parent management training: evidence, outcomes, and issues. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Errorless compliance training with physically abusive mothers: a single-case approach. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Randomized cluster trial of a parenting program in Chile: Key mediators in the decrease in behavior problems in preschool children. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Evaluating a training program for parental educators. [2013]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Common elements of parent management training programs for preschool children with autism spectrum disorder. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

A Modular, Transdiagnostic Approach to Treating Severe Irritability in Children and Adolescents. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Brief behavioral intervention for young children with disruptive behaviors. [2021]