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Disruptive BehaviorNCT03697837

Digital Parent Training for Disruptive Behaviors in Children

A study testing Parent Management Training in people with Disruptive Behavior and Aggression Childhood, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 9 years
Conditions the study is for
Disruptive Behavior, Aggression Childhood, Anger
What is being tested?
Parent Management Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
18 Sep 2018to 1 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

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 3 to 9 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Yale Child Study Center

    New Haven, Connecticut, 06530

Other trials in United States

About this study

Official title: Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents

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.

Being tested
Parent Management Training
Medical subject headings
Problem Behavior, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Parent Management TrainingBehavioural

    Also called Digitally-delivered Parent Management Training, PMT

    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.

Study groups in NCT03697837
Study groupRoleWhat they receive
Parent Management TrainingExperimentalParents will receive a web-based parenting intervention for tantrums and disruptive behavior in young children
Receives: Behavioral: Parent Management Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility measured by Program completion

    Measured by completion of 80% or more of the modules

    Measured: Endpoint- Week 6

  2. Feasibility measured by Attendance

    Attendance to two of the three videoconferencing sessions

    Measured: Endpoint- Week 6

  3. Acceptability measured by Patient Satisfaction Questionnaires

    15-item scale measuring satisfaction of participants with clinical intervention

    Measured: Endpoint- Week 6

Secondary outcomes (5)

  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).

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Screening (Week 0) and Endpoint (Week 6)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2018
  2. Study start18 Sep 2018
  3. Primary completion1 Feb 2020
  4. Study completion1 Jun 2020

Resources

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
Open feasibility trial
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03697837
Sponsor's protocol ID
0102012121-E
Other IDs
18-004680
Status last verified
Dec 2020
First submitted
25 Sep 2018
Last updated
4 Dec 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Parent Management Training in people with Disruptive Behavior and Aggression Childhood, run by Yale University 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 4 Dec 2020. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility measured by Program completion (time frame: Endpoint- Week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03697837, which also lists 1 linked publication.

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 4 Dec 2020.

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