Anxiety Disorders Clinical Trial
| NCT number | NCT02095340 |
| Other study ID # | 2014-0035 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 2014 |
| Est. completion date | April 30, 2018 |
| Verified date | February 2020 |
| Source | University of Houston |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 210 |
| Est. completion date | April 30, 2018 |
| Est. primary completion date | April 30, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 8 Years to 12 Years |
| Eligibility |
Inclusion Criteria: - Children ages 8-12 - Children with primary diagnosis of anxiety disorder - Mothers with clinical levels of anxiety symptoms on the Depression, Anxiety, and Stress Scales (DASS; Lovibond & Lovibond, 1995) Exclusion Criteria: - Physical disability impairing ability to use a computer - Intelligence Quotient <80 - Reading comprehension and fluency composite <75 - Concurrent primary diagnosis of any non-anxiety disorder - Currently receiving psychological or pharmacological treatment for anxiety - Danger to self/others - Non-English speaking child/parent - Maternal current involvement in cognitive-behavioral therapy - Maternal changes in pharmacological treatment in the 12 weeks prior to enrollment. |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Houston | Houston | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| University of Houston |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | Participants will be assessed, on average, within 20 minutes after the intervention. | |
| 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. | Immediately after the intervention, an average of 10 minutes. |
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