Parent Management Training for Irritability
(PMT Trial)
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Colorado, Denver
Disqualifiers: Psychiatric instability, PTSD, Autism, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This is a pilot study to determine if the investigator can accrue a diverse sample of 18 children with significant irritability, conduct manualized Parent Management Training (PMT) with this group and measure physiology during a frustration task pre- and post- PMT sessions. 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.
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.
12345Is 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.
56789How 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.
110111213Eligibility 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.
Trial 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)
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Parent Management TrainingExperimental Treatment1 Intervention
12 sessions of manualized Parent Management Training.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Childrens Hospital ColoradoAurora, CO
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Who Is Running the Clinical Trial?
University of Colorado, DenverLead Sponsor
Childrens Hospital ColoradoCollaborator
Children's Hospital ColoradoCollaborator
References
The outcome of group parent training for families of children with attention-deficit hyperactivity disorder and defiant/aggressive behavior. [2019]The effects of group parent training on parent behavior, and on the behavior of 45 children with attention-deficit hyperactivity disorder and defiant aggressive behavior, were evaluated with a pre-post design. Parent training included didactics on the features and etiology of ADHD and its relationship to defiant/aggressive behavior, as well as parenting skills that adhered to parameters established in the Behavior Management Flow Chart (BMFC). The logic that guided the construction of the program and the unique aspects in the form and content of the parent training are identified. Outcome data show that training reduced childrens' hyperactive, defiant, and aggressive behavior, improved parenting behavior, and reduced parent stress. These data are comparable to previous outcome research evaluating the efficacy of parent training with the BMFC. The advantages of programs that are efficacious in group settings are discussed.
Parent management training for conduct problems in children: Enhancing treatment to improve therapeutic change. [2020]Background/Objective: The study evaluated two variations of Parent Management Training (PMT) for children referred to treatment for oppositional, aggressive, and antisocial behavior. The goal was to evaluate the impact of multiple enhancements to optimize common and placebo factors to augment therapeutic change. Method: The families of all children (N=138, 39 girls and 99 boys, ages 6-13) received PMT. One half of the families were assigned to receive an enhanced version with multiple additions designed to increase bonding of the parent to the therapist, professionalism of treatment and setting, credibility of the intervention, and expectancies for therapeutic change. Assessment included multiple treatment outcome measures of the child (problem behaviors, psychiatric symptoms, social competence, and adaptive functioning) and parents (depression, stress, and family relations) showed marked improvements over the course of treatment, and several process measures (therapeutic alliance, credibility of the procedures, expectancy for change). Results: The results indicated that children and parents made marked improvement in all the treatment outcome measures. The vast majority of children fell within the normative range at posttreatment on problem and prosocial behaviors. The two treatment conditions were no different in outcomes for children or parents. Conclusion: PMT led to marked changes in treatment outcome.
Does parent management training for children with externalizing problem behavior in routine care result in clinically significant changes? [2015]The clinical significance of a parent management training that is part of the Prevention Program for Externalizing Problem Behavior (PEP) was assessed in an effectiveness trial. Parent management training was offered under routine care conditions in a setting where a high proportion of children were expected to show clinically relevant symptoms of externalizing problem behavior. At the beginning of the study, 32.6% to 60.7% of children were classified as clinical cases (dysfunctional) on three outcome measures of child behavior problems. Three months after treatment, 24.8% to 60.4% of children were judged to be recovered. Parent management training can result in clinically significant changes in children with externalizing behavior problems.
Feasibility and Acceptability of a Compressed Caregiver Training Program to Treat Child Behavior Problems. [2023]In an effort to address some of the criticisms of Behavioral Parent Training programs (BPT; high attrition, reliance on caregiver report measures), the current study examined the feasibility, acceptability, and outcome of an intensive behavior treatment program (120-minute sessions for 5 days/week over the course of 2 weeks). Using a changing criterion single case experimental design, 12 children (M child age = 4.9 years) and their primary caregivers completed the 2-week function-based intervention procedure designed to increase children's frustration tolerance via a wait training procedure based on the principles of applied behavior analysis. Using both direct observation and standardized measures, results indicated that the treatment was effective in reducing childhood behavior problems, both within and between appointments (Cohen's ds = 3.2 and 1.37, respectively). Preliminary evidence suggests that a compressed treatment package designed to train caregivers in function-based intervention strategies is feasible and acceptable.
Treatment effectiveness of a brief behavioral intervention for preschool disruptive behavior. [2021]Parent management training is an evidence-based treatment for disruptive behavior. However, the number of treatment sessions can be high, contributing to high attrition rates. The purpose of this study was to examine post-treatment, 6-month, and 1-year treatment outcomes of the Brief Behavioral Intervention. One hundred twenty children aged 2-6.5 years demonstrating clinically significant disruptive behavior were referred to an outpatient clinic for treatment and participated in the study. Attrition was below reported rates in the literature. Significant decreases in child disruptive behavior and parent stress were found from pre-to-post intervention, and improvements were maintained at follow-ups. Significant pre-to-post intervention teacher reported decreases in behavior were reported.
Tantrum Tool: Development and Open Pilot Study of Online Parent Training for Irritability and Disruptive Behavior. [2021]Objectives: Parent management training is an effective treatment for disruptive behavior disorders but it is often underutilized in clinical settings. Access to care is limited due to logistical barriers as well as limited service availability. This study examines in an open trial the acceptability, feasibility, and clinical effects of a digital parent management training intervention that includes videoconference coaching, called "Tantrum Tool." Methods: Fifteen children, ages 3-9 years, participated in an open trial of an 8-week intervention. The primary symptom measure was the Disruptive Behavior Rating Scale (DBRS), and the secondary outcome measure was the Affective Reactivity Index (ARI) completed by the primary caregiver before and after treatment. Results: Treatment retention was high (80%), and parents reported a high level of satisfaction with the program. There was a significant reduction in the mean DBRS score from 13.5 ± 5.5 at baseline to 7.3 ± 3.4 at endpoint, p < 0.001. There was also a significant reduction in the mean ARI irritability score from 7.2 ± 2.6 at baseline to 3.75 ± 2.1 at endpoint, p < 0.01. Conclusions: This open pilot study supports the feasibility and acceptability of a digital parent training program for young children with disruptive behavior. Findings provide preliminary support for a clinically meaningful reduction of both disruptive behavior and irritability. Using the Tantrum Tool to deliver online treatment for children could increase access to first-line treatments for disruptive behavior and irritability in young children. ClinicalTrials.gov: NCT03697837.
Parent management training: evidence, outcomes, and issues. [2022]To describe and evaluate parent management training (PMT) as a treatment technique for oppositional, aggressive, and antisocial behavior.
Errorless compliance training with physically abusive mothers: a single-case approach. [2019]"Errorless compliance training" is a recently developed, success-based approach for teaching children to comply with parental requests without the use of coercive consequences. Two mothers were trained to use this intervention to reduce severe child defiance that was precipitating mother/child confrontations and physical abuse.
Randomized cluster trial of a parenting program in Chile: Key mediators in the decrease in behavior problems in preschool children. [2022]Parenting training is a proven strategy for the promotion of positive parenting practices and for the prevention and treatment of behavior problems in children. The processes that explain this efficacy are less clear. The aim of this study was to assess the mediating role of parenting practice modification, encouraged through the implementation of a universal parenting training program, for the decrease of behavior problems in 3- to 6-year-old children.
Evaluating a training program for parental educators. [2013]This paper describes and evaluates a training program for parental educators to teach parenting classes for families with children 1 to 5 years of age. Six staff and parent volunteers from a family resource center participated. Evaluations of the training program showed improved knowledge and increased comfort in teaching parenting classes. Two graduates of the training program led a 10-week series of parenting classes. Parents in their class series (n = 9) significantly reduced their reported use of verbal and corporal punishment, increased their nurturing, and improved their perceptions of their children's behavior. These results were similar to those from a series of similar classes for 15 parents led by a university instructor. Results are discussed in terms of research needs for training qualified parental educators.
Common elements of parent management training programs for preschool children with autism spectrum disorder. [2022]Parent management training is a general set of interventions used as a part of a variety of clinical approaches to reduce behavioral problems of children. These behavioral problems in children with special needs (such as autism spectrum disorder) take a more complex form. The objective is to present elements, needed to develop parent management training program to reduce behavioral problems in preschool children with autism spectrum disorder. At first, all parent management training programs for reducing behavioral problems of preschool children were collected. Subsequently, all programs were reviewed from the perspective of having a systematic review or meta-analysis, confirming the effectiveness of this program at preschool age. After that, interviews with experts and parents were conducted to identify effective elements on development of this program. In the next step, a set of components was obtained using information about parent management training programs as well as items obtained from interviews with experts and parents. At this stage, 10 experts were asked to rate the items according to their importance using the Delphi method. The items that achieved the required scores were introduced as main items. The number of them was 13 and included items such as full assessment of the child and appropriate communication with the child. Considering the characteristics of children with autism spectrum disorder will require changes in some parts of parent management training program, therefore, it is necessary to develop a specific program for these children to cover all of their characteristics.
A Modular, Transdiagnostic Approach to Treating Severe Irritability in Children and Adolescents. [2021]Severe irritability is common in treatment-referred youth, often occurring in externalizing, anxiety, and mood conditions. The best available evidence indicates behavioral parent training and cognitive-behavioral therapy as first-line interventions. Modular approaches (eg, MATCH) can package these strategies in a flexible format, facilitating personalization. Ample evidence supports MATCH's effectiveness generally and initial evidence supports its effectiveness for irritability specifically. We provide an overview of MATCH and its application to severe irritability. Emphasis is placed on behavioral parent training as a likely primary/first-line treatment. Potential benefits and limitations are considered. This approach calls for careful clinical judgment and for further empirical research.
Brief behavioral intervention for young children with disruptive behaviors. [2021]Parent reported behavioral difficulties in young children are relatively common. Without adequate intervention, some children will later present with more severe problem behaviors. Parent management training is one of the best methods of treatment for behavior problems; however, existing treatments can be lengthy and difficult to conduct outside of a research setting. The Brief Behavioral Intervention was designed as a briefer version of a manualized parent management training treatment package. Thirty-one parents of children aged 2-6.5 presenting with behavior problems were included in this initial study of treatment effectiveness. Based on parent and teacher report, treatment was effective in a mean of 7.2 sessions.