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| ID | Type | Description | Link |
|---|---|---|---|
| 18-004680 | Other Grant/Funding Number | AACAP- Elaine Schlosser Lewis Fund |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parent Management Training | Experimental | Parents will receive a web-based parenting intervention for tantrums and disruptive behavior in young children |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility measured by Program completion | Measured by completion of 80% or more of the modules | Endpoint- Week 6 |
| Feasibility measured by Attendance | Attendance to two of the three videoconferencing sessions | Endpoint- Week 6 |
| Acceptability measured by Patient Satisfaction Questionnaires | 15-item scale measuring satisfaction of participants with clinical intervention | Endpoint- Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denis G Sukhodolsky, Ph.D. | Yale University | Principal Investigator |
| Andrea Diaz Stransky, M.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Child Study Center | New Haven | Connecticut | 06530 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33035067 | Derived | 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. |
| Label | URL |
|---|---|
| Web-based platform for digitally delivered intervention | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 28, 2018 | Oct 3, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000066553 | Problem Behavior |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D002652 | Child Behavior |
| D010342 | Patient Acceptance of Health Care |
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Open feasibility trial
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| Baseline (Week 0) and End-point (Week 6) |
| 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. | Baseline (Week 0) and End-point (Week 6) |
| 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. | Baseline (Week 0) and Endpoint (Week 6) |
| 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. | Baseline (Week 0) and Endpoint (Week 6) |
| 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. | Screening (Week 0) and Endpoint (Week 6) |
| D000074822 |
| Treatment Adherence and Compliance |
| D015438 | Health Behavior |