Effects of Maternal Interpretation Biases on Child Anxiety and Related Responses

• Sponsor: University of Houston (Other)
• Overall Status: Completed
• CT.gov ID: NCT02095340
• Collaborator: (none)
• Enrollment: 210
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 4.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorders	Other: Positive Interpretation Bias Training; Other: Neutral Interpretation Bias Training	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Basic Science
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: Apr 30, 2018
• Actual Study Completion Date: Apr 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Positive Training	Other: Positive Interpretation Bias Training
Sham Comparator: Neutral Training	Other: Neutral Interpretation Bias Training

Outcome Measures

Primary Outcome Measures

1. Word Sentence Association Paradigm [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.

2. Maternal Anxious Behavior Coded by Independent Observers. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Houston	Houston	Texas	United States	77204

Sponsors and Collaborators

• University of Houston

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 5, 2016

More Information

Publications

None provided.

• Responsible Party: Andres G. Viana, Assistant Professor, University of Houston
• ClinicalTrials.gov Identifier: NCT02095340
• Other Study ID Numbers: 2014-0035
• First Posted: Mar 24, 2014
• Last Update Posted: Feb 27, 2020
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

Participant Flow

Arm/Group Title	Positive Training	Neutral Training	Child Interpretation Biases Assessment
Arm/Group Description	Positive Interpretation Bias Training	Neutral Interpretation Bias Training	All children, regardless of whether the parent was assigned to either the positive or neutral training condition, completed a single assessment of interpretation biases.
Period Title: Overall Study
STARTED	51	54	105
COMPLETED	51	54	105
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Positive Training	Neutral Training	Child Interpretation Biases Assessment	Total
Arm/Group Description	Positive Interpretation Bias Training	Neutral Interpretation Bias Training	All children, regardless of whether the parent was assigned to either the positive or neutral training condition, completed a single assessment of interpretation biases.	Total of all reporting groups
Overall Participants	51	54	105	210
Age (Count of Participants)
<=18 years	0 0%	0 0%	105 100%	105 50%
Between 18 and 65 years	51 100%	54 100%	0 0%	105 50%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.73 (6.92)	39.94 (7.19)	10.07 (1.22)	29.58 (5.11)
Sex: Female, Male (Count of Participants)
Female	51 100%	54 100%	60 57.1%	165 78.6%
Male	0 0%	0 0%	45 42.9%	45 21.4%
Race/Ethnicity, Customized (Count of Participants)
Hispanic/Latino	13 25.5%	18 33.3%	30 28.6%	61 29%
African American	7 13.7%	8 14.8%	15 14.3%	30 14.3%
White American	27 52.9%	27 50%	40 38.1%	94 44.8%
Asian American	2 3.9%	0 0%	2 1.9%	4 1.9%
Mixed Ethnicity	2 3.9%	1 1.9%	18 17.1%	21 10%
Region of Enrollment (participants) [Number]
United States	51 100%	54 100%	105 100%	210 100%
Word-Sentence Association Paradigm (Units on a Scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a Scale]	0.53 (0.14)	0.52 (0.12)	0.27 (0.15)	0.44 (0.14)

Outcome Measures

1. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Positive Training	Neutral Training	Child Interpretation Biases Assessment
Arm/Group Description	Positive Interpretation Bias Training	Neutral Interpretation Bias Training	All children completed a Child Interpretation Biases Assessment once.
Measure Participants	50	52	105
Mean (Standard Deviation) [units on a scale]	0.37 (0.16)	0.52 (0.14)	0.27 (0.15)

2. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Positive Training	Neutral Training	Child Interpretation Biases Assessment
Arm/Group Description	Positive Interpretation Bias Training	Neutral Interpretation Bias Training	Child Interpretation Biases Assessment
Measure Participants	51	54	105
Mean (Standard Deviation) [units on a scale]	1.43 (0.81)	1.70 (0.79)	2.02 (0.93)

Adverse Events

Time Frame	The day of the intervention.
Adverse Event Reporting Description	There were no adverse events or serious adverse events during the trial. All-Cause Mortality was not monitored/assessed and therefore the total number of participants at risk is listed as zero ("0").
Arm/Group Title	Positive Training		Neutral Training		Child Interpretation Biases Assessment
Arm/Group Description	Positive Interpretation Bias Training		Neutral Interpretation Bias Training		Child Interpretation Biases Assessment
All Cause Mortality
	Positive Training		Neutral Training		Child Interpretation Biases Assessment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Positive Training		Neutral Training		Child Interpretation Biases Assessment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/54 (0%)		0/105 (0%)
Other (Not Including Serious) Adverse Events
	Positive Training		Neutral Training		Child Interpretation Biases Assessment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/54 (0%)		0/105 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.