Anxiety Disorders
Conditions
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.
Interventions
OTHERPositive Interpretation Bias Training
OTHERNeutral Interpretation Bias Training
Sponsors
University of Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Positive Training Positive Interpretation Bias Training | 51 |
| Neutral Training Neutral Interpretation Bias Training | 54 |
| Child Interpretation Biases Assessment All children, regardless of whether the parent was assigned to either the positive or neutral training condition, completed a single assessment of interpretation biases. | 105 |
| Total | 210 |
Baseline characteristics
| Characteristic | Positive Training | Neutral Training | Child Interpretation Biases Assessment | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 105 Participants | 105 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 54 Participants | 0 Participants | 105 Participants |
| Age, Continuous | 38.73 years STANDARD_DEVIATION 6.92 | 39.94 years STANDARD_DEVIATION 7.19 | 10.07 years STANDARD_DEVIATION 1.22 | 29.58 years STANDARD_DEVIATION 5.11 |
| Race/Ethnicity, Customized African American | 7 Participants | 8 Participants | 15 Participants | 30 Participants |
| Race/Ethnicity, Customized Asian American | 2 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 13 Participants | 18 Participants | 30 Participants | 61 Participants |
| Race/Ethnicity, Customized Mixed Ethnicity | 2 Participants | 1 Participants | 18 Participants | 21 Participants |
| Race/Ethnicity, Customized White American | 27 Participants | 27 Participants | 40 Participants | 94 Participants |
| Region of Enrollment United States | 51 participants | 54 participants | 105 participants | 210 participants |
| Sex: Female, Male Female | 51 Participants | 54 Participants | 60 Participants | 165 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 45 Participants | 45 Participants |
| Word-Sentence Association Paradigm | 0.53 Units on a Scale STANDARD_DEVIATION 0.14 | 0.52 Units on a Scale STANDARD_DEVIATION 0.12 | 0.27 Units on a Scale STANDARD_DEVIATION 0.15 | 0.44 Units on a Scale STANDARD_DEVIATION 0.14 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 51 | 0 / 54 | 0 / 105 |
| serious Total, serious adverse events | 0 / 51 | 0 / 54 | 0 / 105 |
Outcome results
Primary
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.
Time frame: Immediately after the intervention, an average of 10 minutes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Training | Maternal Anxious Behavior Coded by Independent Observers. | 1.43 units on a scale | Standard Deviation 0.81 |
| Neutral Training | Maternal Anxious Behavior Coded by Independent Observers. | 1.70 units on a scale | Standard Deviation 0.79 |
| Child Interpretation Biases Assessment | Maternal Anxious Behavior Coded by Independent Observers. | 2.02 units on a scale | Standard Deviation 0.93 |
Primary
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.
Time frame: Participants will be assessed, on average, within 20 minutes after the intervention.
Population: Data for one participant in the positive training condition and two participants in the neutral training condition was lost due to equipment malfunction.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Training | Word Sentence Association Paradigm | 0.37 units on a scale | Standard Deviation 0.16 |
| Neutral Training | Word Sentence Association Paradigm | 0.52 units on a scale | Standard Deviation 0.14 |
| Child Interpretation Biases Assessment | Word Sentence Association Paradigm | 0.27 units on a scale | Standard Deviation 0.15 |