Anxiety DisordersNCT02095340

Effects of Maternal Interpretation Biases on Child Anxiety and Related Responses

A study testing Positive Interpretation Bias Training and Neutral Interpretation Bias Training in people with Anxiety Disorders, run by University of Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 8 to 12 yearsHealthy volunteers can take part
Conditions the study is for: Anxiety Disorders
What is being tested?: Positive Interpretation Bias Training and Neutral Interpretation Bias Training
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 210 participants
Where: 1 siteUnited States
Study dates: May 2014to 30 Apr 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 to 12 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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)

Who cannot join

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

Show all 9Show fewer

Non-English speaking child/parent
Maternal current involvement in cognitive-behavioral therapy
Maternal changes in pharmacological treatment in the 12 weeks prior to enrollment.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Houston
Houston, Texas, 77204

Other trials in United States

About this study

Conditions: Anxiety Disorders
Being tested: Positive Interpretation Bias Training, Neutral Interpretation Bias Training
Medical subject headings: Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Positive Interpretation Bias TrainingOther
Neutral Interpretation Bias TrainingOther

Study groups in NCT02095340
Study group	Role	What they receive
Positive Training	Experimental	Not described Receives: Other: Positive Interpretation Bias Training
Neutral Training	Sham comparator	Not described Receives: Other: Neutral Interpretation Bias Training

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Immediately after the intervention, an average of 10 minutes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 201430 Apr 2018

First posted24 Mar 2014 (estimated)
Study startMay 2014
Primary completion30 Apr 2018
Study completion30 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Anxiety DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 210 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02095340
Sponsor's protocol ID: 2014-0035
Status last verified: Feb 2020
First submitted: 19 Mar 2014
Last updated: 27 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 32692282
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.
PubMed 32524580
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.
PubMed 31802369
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.
PubMed 31494512

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Anxiety Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Maternal Interpretation Biases on Child Anxiety and Related Responses
ClinicalTrials.gov ID: NCT02095340
Acronym / sponsor ID: 2014-0035
Conditions: Anxiety Disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 210 participants (actual)
Lead sponsor: University of HoustonUniversity, hospital or other
Study start: May 2014
Primary completion: 30 Apr 2018 (actual)
Study completion: 30 Apr 2018 (actual)
First posted: 24 Mar 2014 (estimated)
Results: Posted 27 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Positive Training	Experimental	Other: Positive Interpretation Bias Training
Neutral Training	Sham comparator	Other: Neutral Interpretation Bias Training

Who may qualify

Ages: 8 to 12 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Positive Interpretation Bias Training	Other	Positive Training
Neutral Interpretation Bias Training	Other	Neutral Training

Primary outcome

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.
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.

Results and safety

Results posted to the registry on 27 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Positive Training	51	51
Neutral Training	54	54
Child Interpretation Biases Assessment	105	105

Primary outcome: Word Sentence Association Paradigm

Time frame: Participants will be assessed, on average, within 20 minutes after the intervention.. Mean (Standard Deviation). Unit: units on a scale

Measure	Positive Training n = 50	Neutral Training n = 52	Child Interpretation Biases Assessment n = 105
Value	0.37 (0.16)	0.52 (0.14)	0.27 (0.15)

Population analysed: Data for one participant in the positive training condition and two participants in the neutral training condition was lost due to equipment malfunction.

Primary outcome: Maternal Anxious Behavior Coded by Independent Observers.

Time frame: Immediately after the intervention, an average of 10 minutes.. Mean (Standard Deviation). Unit: units on a scale

Measure	Positive Training n = 51	Neutral Training n = 54	Child Interpretation Biases Assessment n = 105
Value	1.43 (0.81)	1.70 (0.79)	2.02 (0.93)

Adverse events

Time frame: The day of the intervention.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Positive Training	0 of 51 (0%)	0 of 51 (0%)
Neutral Training	0 of 54 (0%)	0 of 54 (0%)
Child Interpretation Biases Assessment	0 of 105 (0%)	0 of 105 (0%)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32692282Raines 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.
Derived from this study: PubMed 32524580Trent 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.
Derived from this study: PubMed 31802369Trent 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.
Derived from this study: PubMed 31494512Raines 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Positive Interpretation Bias Training and Neutral Interpretation Bias Training in people with Anxiety Disorders, run by University of Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Word Sentence Association Paradigm (time frame: Participants will be assessed, on average, within 20 minutes after the intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02095340, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2020.