Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to expand our understanding of the intergenerational transmission of cognitive risk for childhood anxiety disorders by examining whether changes in maternal interpretations of situations result in changes in child interpretations and child anxiety.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Training | Experimental |
| |
| Neutral Training | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Interpretation Bias Training | Other |
| ||
| Neutral Interpretation Bias Training |
| Measure | Description | Time Frame |
|---|---|---|
| Word Sentence Association Paradigm | Proportion of threatening (versus nonthreatening) interpretations made on the Word Sentence Association Paradigm (WSAP). Scores range from 0 to 1. Higher scores mean a worse outcome, that is, more negative interpretations. | Participants will be assessed, on average, within 20 minutes after the intervention. |
| Maternal Anxious Behavior Coded by Independent Observers. | Maternal anxious behavior coded by independent observers on a 0 - 4 scale. Higher numbers indicated more observed anxious behaviors. | Immediately after the intervention, an average of 10 minutes. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Houston | Houston | Texas | 77204 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32692282 | Derived | Raines EM, Viana AG, Trent ES, Conroy HE, Woodward EC, Zvolensky MJ, Storch EA. The explanatory role of anxiety sensitivity in the association between effortful control and child anxiety and depressive symptoms. Cogn Behav Ther. 2020 Nov;49(6):501-517. doi: 10.1080/16506073.2020.1790644. Epub 2020 Jul 21. | |
| 32524580 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Positive Training | Positive Interpretation Bias Training |
| FG001 | Neutral Training | Neutral Interpretation Bias Training |
| FG002 | Child Interpretation Biases Assessment | All children, regardless of whether the parent was assigned to either the positive or neutral training condition, completed a single assessment of interpretation biases. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Positive Training | Positive Interpretation Bias Training |
| BG001 | Neutral Training | Neutral Interpretation Bias Training |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Word Sentence Association Paradigm | Proportion of threatening (versus nonthreatening) interpretations made on the Word Sentence Association Paradigm (WSAP). Scores range from 0 to 1. Higher scores mean a worse outcome, that is, more negative interpretations. | Data for one participant in the positive training condition and two participants in the neutral training condition was lost due to equipment malfunction. | Posted | Mean | Standard Deviation | units on a scale | Participants will be assessed, on average, within 20 minutes after the intervention. |
|
The day of the intervention.
There were no adverse events or serious adverse events during the trial. All-Cause Mortality was not monitored/assessed and therefore the total number of participants at risk is listed as zero ("0").
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Positive Training | Positive Interpretation Bias Training | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andres G Viana, Ph.D., Associate Professor | University of Houston | 832-842-0234 | agviana@uh.edu |
Not provided
| 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 | Jan 5, 2016 | Oct 10, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
|
| Trent ES, Viana AG, Raines EM, Conroy HE, Storch EA, Zvolensky MJ. Interpretation biases and depressive symptoms among anxiety-disordered children: The role of individual differences in respiratory sinus arrhythmia. Dev Psychobiol. 2021 Mar;63(2):320-337. doi: 10.1002/dev.22002. Epub 2020 Jun 10. |
| 31802369 | Derived | Trent ES, Viana AG, Raines EM, Woodward EC, Candelari AE, Storch EA, Zvolensky MJ. Interpretation Biases and Childhood Anxiety: The Moderating Role of Parasympathetic Nervous System Reactivity. J Abnorm Child Psychol. 2020 Mar;48(3):419-433. doi: 10.1007/s10802-019-00605-7. |
| 31494512 | Derived | Raines EM, Viana AG, Trent ES, Woodward EC, Candelari AE, Zvolensky MJ, Storch EA. Effortful control, interpretation biases, and child anxiety symptom severity in a sample of children with anxiety disorders. J Anxiety Disord. 2019 Oct;67:102136. doi: 10.1016/j.janxdis.2019.102136. Epub 2019 Aug 27. |
| BG002 | Child Interpretation Biases Assessment | All children, regardless of whether the parent was assigned to either the positive or neutral training condition, completed a single assessment of interpretation biases. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Word-Sentence Association Paradigm | Proportion of threatening vs non-threatening interpretations made on the modified version of the Word Sentence Association Paradigm (WSAP). Score ranges from 0 to 1. Higher scores indicate worse outcome, that is, more negative interpretation biases. | Mean | Standard Deviation | Units on a Scale |
|
Neutral Interpretation Bias Training
| OG002 | Child Interpretation Biases Assessment | All children completed a Child Interpretation Biases Assessment once. |
|
|
| Primary | Maternal Anxious Behavior Coded by Independent Observers. | Maternal anxious behavior coded by independent observers on a 0 - 4 scale. Higher numbers indicated more observed anxious behaviors. | Posted | Mean | Standard Deviation | units on a scale | Immediately after the intervention, an average of 10 minutes. |
|
|
|
| 0 |
| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | Neutral Training | Neutral Interpretation Bias Training | 0 | 0 | 0 | 54 | 0 | 54 |
| EG002 | Child Interpretation Biases Assessment | Child Interpretation Biases Assessment | 0 | 0 | 0 | 105 | 0 | 105 |
Not provided
Not provided