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Completed

NCT Number: NCT03697837

Digital Parent Training for Disruptive Behaviors in Children

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.

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Key information

Conditions

Disruptive Behavior Aggression Childhood Anger Behavior Behavioral Symptoms Child Behavior Health Behavior Irritable Mood Non-Compliance, Patient Patient Acceptance of Health Care Patient Compliance Problem Behavior Treatment Adherence and Compliance

Age range

3 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale Child Study Center

New Haven, Connecticut, 06530, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Parent Management Training

Behavioral

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.

Other names: Digitally-delivered Parent Management Training, PMT

Primary outcomes

  1. Feasibility measured by Program completion

    Time frame: Endpoint- Week 6

    Measured by completion of 80% or more of the modules

  2. Feasibility measured by Attendance

    Time frame: Endpoint- Week 6

    Attendance to two of the three videoconferencing sessions

  3. Acceptability measured by Patient Satisfaction Questionnaires

    Time frame: Endpoint- Week 6

    15-item scale measuring satisfaction of participants with clinical intervention

Secondary outcomes

  1. Disruptive Behavior Rating Scale

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

    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).

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

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

    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.

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

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

    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.

  4. CBCL - Child Behavior Checklist

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

    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.

  5. ARI-Affective Reactivity Index

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

    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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 5, 2018
Registry last updated
Dec 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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