NCT02095340

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 24, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

February 27, 2020

Completed
Last Updated

February 27, 2020

Status Verified

February 1, 2020

Enrollment Period

4 years

First QC Date

March 19, 2014

Results QC Date

October 10, 2019

Last Update Submit

February 12, 2020

Conditions

Anxiety Disorders

Outcome Measures

Primary Outcomes (2)

  • 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.

Study Arms (2)

Positive Training

EXPERIMENTAL
Other: Positive Interpretation Bias Training

Neutral Training

SHAM COMPARATOR
Other: Neutral Interpretation Bias Training

Interventions

Positive Interpretation Bias TrainingOTHER
Positive Training
Neutral Interpretation Bias TrainingOTHER
Neutral Training

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Houston

Houston, Texas, 77204, United States

Location

Related Publications (4)

  • 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.

    PMID: 32692282DERIVED

  • 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.

    PMID: 32524580DERIVED

  • 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.

    PMID: 31802369DERIVED

  • 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.

    PMID: 31494512DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

Title
Andres G Viana, Ph.D., Associate Professor
Organization
University of Houston
agviana@uh.edu
832-842-0234

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 19, 2014

First Posted

March 24, 2014

Study Start

May 1, 2014

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

February 27, 2020

Results First Posted

February 27, 2020

Record last verified: 2020-02

Locations

US(1)