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CompletedNCT03697837Updated Dec 4, 2020

Digital Parent Training for Disruptive Behaviors in Children

An interventional study of Parent Management Training in Disruptive Behavior, Aggression Childhood and Anger, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 3 Years to 9 Years. Per ClinicalTrials.gov, last updated 2020-12-04.

Sponsored by Yale University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
3 Years to 9 Years
Sex
All
01

Study summary

This is an open pilot trial of web-based parent training for tantrums and disruptive behavior in children. Parents will be asked to complete a battery of tests to assess their children' behaviors before and after the intervention. Children will undergo a psychiatric evaluation as part of screening. The intervention will be delivered online via an app over a period of 6 weeks. It consists of 8 self-guided courses that take approximately 10 minutes to complete and include text and animated parent-child simulations. Parents will also complete 3 one-hour videoconferencing sessions with a study clinician. During the intervention, parents will be taught various strategies for managing situations that can be anger provoking for their child. This study is conducted to examine whether a digitally-delivered version of parent-management training can be used to reduce behavioral problems including anger outbursts, irritability, aggression and noncompliance.

02

Conditions studied

  • Disruptive Behavior
  • Aggression Childhood
  • Anger
  • Non-Compliance, Patient
  • Irritable Mood
03

In context

Aggression

361 studies on the registry are indexed under Aggression; 51 are open to participants now.

This study's enrollment of 16 is below the median of 60 across 293 interventional studies indexed under Aggression.

Browse Aggression studies →

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Parents have access to a mobile device and/or computer device
  • Parents speak English as native language
  • Families agree not to initiate new mental health treatments for the duration of this study.
  • Child meets diagnostic criteria for one of the Disruptive Behavior Disorders
  • Affective Reactivity Index parent-report score is above 3.6, which is the mean for children with severe irritability
  • Lives within driving distance from New Haven, CT

Exclusion criteria

Exclusion Criteria:

  • Parents have previously received parent-training by a licensed provider.
  • Untreated medical or psychiatric disorder that requires immediate intervention
  • Child is non-verbal or minimally verbal
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Parent Management Training

    Parents will receive a web-based parenting intervention for tantrums and disruptive behavior in young children

    Behavioral: Parent Management Training

Interventions

  • BehavioralParent Management Training

    The online digital parent training (DPT) program consists of 8 self-guided courses that take approximately 10 minutes to complete and include text and animated parent-child simulations. The courses are designed to closely parallel the content of existing evidence-based parent management training approaches that exist in numerous parenting books.

    Also known as: Digitally-delivered Parent Management Training, PMT

06

What researchers measure

Primary outcomes

  1. Feasibility measured by Program completion

    Measured by completion of 80% or more of the modules

    Time frame: Endpoint- Week 6

  2. Feasibility measured by Attendance

    Attendance to two of the three videoconferencing sessions

    Time frame: Endpoint- Week 6

  3. Acceptability measured by Patient Satisfaction Questionnaires

    15-item scale measuring satisfaction of participants with clinical intervention

    Time frame: Endpoint- Week 6

Secondary outcomes

  1. Disruptive Behavior Rating Scale

    16-item rating scale used to assess inattention, hyperactivity-impulsivity, and oppositional defiant behavior among school-aged children. It includes two 8 question subscales, one of which assesses the frequency of these constructs while the other assesses the interference of these constructs in different parts of the child's life. Each item is graded between 0-3 so that each sub-scale has a maximum score of 24 and a minimum score of 0 with a total range of 24. The two subscales are not combined in any way. Higher values are a worse outcome as they either represent a greater frequency or interference (depending on the sub-scale).

    Time frame: Baseline (Week 0) and End-point (Week 6)

  2. MAP-DB- Multidimensional Assessment of Preschool Disruptive Behavior

    A developmentally sensitive questionnaire that includes \~74 items, to assess frequency of temper loss in terms of tantrum features and anger regulation in preschool-aged children. Will perform a preliminary evaluation of intervention effectiveness by assessing change in pre-post scores. Each item is rated on a 6-point likert scale ranging between "never" to "many times each day". The scoring system for this measure is not published, but the authors of this novel tool have agreed to assist in the scoring of this scale.

    Time frame: Baseline (Week 0) and End-point (Week 6)

  3. SNAP-Swanson, Nolan and Pelham Questionnaire (SNAP)

    Parent and teacher questionnaires with 18 scored items. Items 1-9 assess inattention in children, while items 11-19 assess hyperactivity in children. Each item ranges between 0-3. Items 10 and 20 are not scored. The higher the score, the worse the outcome as the higher scores reflect greater frequency in the child's inattention or hyperactivity. The two sub-scales are not combined.

    Time frame: Baseline (Week 0) and Endpoint (Week 6)

  4. CBCL - Child Behavior Checklist

    The Child Behavior Checklist is a parent rating of child psychopathology that has factor-analytically derived scales of anxiety, depression, and disruptive behavior. It includes 7 general questions about the child's preferences and activities, and 113 items to assess childhood behavior. We will use it to obtain a more detailed characterization of psychopathology in children.

    Time frame: Baseline (Week 0) and Endpoint (Week 6)

  5. ARI-Affective Reactivity Index

    ARI is a 7-item measure of irritability in children and adolescents. Items are rated between 0-2, except for the last item (Number 7) which is not used for scoring. The scale has a minimum score of 0 and a maximum score of 12. An "Affective Reactivity Index Average Score" will be calculated, which is the total score divided by 6. The higher the score, the worse the outcome as this represents greater problems related to irritability. There are no subscales in this measure.

    Time frame: Screening (Week 0) and Endpoint (Week 6)

07

Study locations

1 site
  • Yale Child Study Center
    New Haven, Connecticut 06530, United States
08

References and documents

Publications

  • Diaz-Stransky A, Rowley S, Zecher E, Grodberg D, Sukhodolsky DG. Tantrum Tool: Development and Open Pilot Study of Online Parent Training for Irritability and Disruptive Behavior. J Child Adolesc Psychopharmacol. 2020 Nov;30(9):558-566. doi: 10.1089/cap.2020.0089. Epub 2020 Oct 9. PubMed 33035067 ↗

Study documents

  • Protocol and statistical analysis plan · Aug 28, 2018

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03697837
Lead sponsor
Yale University
Responsible party
Sponsor
First posted
Oct 5, 2018
Start date
Sep 18, 2018
Primary completion
Feb 1, 2020
Completion
Jun 1, 2020
Last update
Dec 4, 2020

Study contacts

Denis G Sukhodolsky, Ph.D.
principal investigator · Yale University
Andrea Diaz Stransky, M.D.
principal investigator · Yale University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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