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Effects of Maternal Interpretation Biases on Child Anxiety and Related Responses

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive Interpretation Bias Training
Neutral Interpretation Bias Training
Sponsored by
University of Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anxiety Disorders

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Positive Training

Neutral Training

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 19, 2014
Last Updated
February 12, 2020
Sponsor
University of Houston
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1. Study Identification

Unique Protocol Identification Number
NCT02095340
Brief Title
Effects of Maternal Interpretation Biases on Child Anxiety and Related Responses
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positive Training
Arm Type
Experimental
Arm Title
Neutral Training
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Positive Interpretation Bias Training
Intervention Type
Other
Intervention Name(s)
Neutral Interpretation Bias Training
Primary Outcome Measure Information:
Title
Word Sentence Association Paradigm
Description
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.
Time Frame
Participants will be assessed, on average, within 20 minutes after the intervention.
Title
Maternal Anxious Behavior Coded by Independent Observers.
Description
Maternal anxious behavior coded by independent observers on a 0 - 4 scale. Higher numbers indicated more observed anxious behaviors.
Time Frame
Immediately after the intervention, an average of 10 minutes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32692282
Citation
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.
Results Reference
derived
PubMed Identifier
32524580
Citation
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.
Results Reference
derived
PubMed Identifier
31802369
Citation
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.
Results Reference
derived
PubMed Identifier
31494512
Citation
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.
Results Reference
derived

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Effects of Maternal Interpretation Biases on Child Anxiety and Related Responses

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