Effects of Maternal Interpretation Biases on Child Anxiety and Related Responses

February 12, 2020 updated by: Andres G. Viana, University of Houston
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77204
        • University of Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Positive Training
Other: Positive Interpretation Bias Training
SHAM_COMPARATOR: Neutral Training
Other: Neutral Interpretation Bias Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Word Sentence Association Paradigm
Time Frame: Participants will be assessed, on average, within 20 minutes after the intervention.
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.
Time Frame: Immediately after the intervention, an average of 10 minutes.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ACTUAL)

April 30, 2018

Study Completion (ACTUAL)

April 30, 2018

Study Registration Dates

First Submitted

March 19, 2014

First Submitted That Met QC Criteria

March 20, 2014

First Posted (ESTIMATE)

March 24, 2014

Study Record Updates

Last Update Posted (ACTUAL)

February 27, 2020

Last Update Submitted That Met QC Criteria

February 12, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-0035

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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