Trial Outcomes & Findings for Effects of Maternal Interpretation Biases on Child Anxiety and Related Responses (NCT NCT02095340)
NCT ID: NCT02095340
Last Updated: 2020-02-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
210 participants
Primary outcome timeframe
Participants will be assessed, on average, within 20 minutes after the intervention.
Results posted on
2020-02-27
Participant Flow
Participant milestones
| Measure |
Positive Training
Positive Interpretation Bias Training
|
Neutral Training
Neutral Interpretation Bias Training
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
51
|
54
|
105
|
|
Overall Study
COMPLETED
|
51
|
54
|
105
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Maternal Interpretation Biases on Child Anxiety and Related Responses
Baseline characteristics by cohort
| Measure |
Positive Training
n=51 Participants
Positive Interpretation Bias Training
|
Neutral Training
n=54 Participants
Neutral Interpretation Bias Training
|
Child Interpretation Biases Assessment
n=105 Participants
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
n=210 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
38.73 years
STANDARD_DEVIATION 6.92 • n=5 Participants
|
39.94 years
STANDARD_DEVIATION 7.19 • n=7 Participants
|
10.07 years
STANDARD_DEVIATION 1.22 • n=5 Participants
|
29.58 years
STANDARD_DEVIATION 5.11 • n=4 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
165 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White American
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Mixed Ethnicity
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
54 participants
n=7 Participants
|
105 participants
n=5 Participants
|
210 participants
n=4 Participants
|
|
Word-Sentence Association Paradigm
|
0.53 Units on a Scale
STANDARD_DEVIATION 0.14 • n=5 Participants
|
0.52 Units on a Scale
STANDARD_DEVIATION 0.12 • n=7 Participants
|
0.27 Units on a Scale
STANDARD_DEVIATION 0.15 • n=5 Participants
|
0.44 Units on a Scale
STANDARD_DEVIATION 0.14 • n=4 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Positive Training
n=50 Participants
Positive Interpretation Bias Training
|
Neutral Training
n=52 Participants
Neutral Interpretation Bias Training
|
Child Interpretation Biases Assessment
n=105 Participants
All children completed a Child Interpretation Biases Assessment once.
|
|---|---|---|---|
|
Word Sentence Association Paradigm
|
0.37 units on a scale
Standard Deviation 0.16
|
0.52 units on a scale
Standard Deviation 0.14
|
0.27 units on a scale
Standard Deviation 0.15
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Positive Training
n=51 Participants
Positive Interpretation Bias Training
|
Neutral Training
n=54 Participants
Neutral Interpretation Bias Training
|
Child Interpretation Biases Assessment
n=105 Participants
All children completed a Child Interpretation Biases Assessment once.
|
|---|---|---|---|
|
Maternal Anxious Behavior Coded by Independent Observers.
|
1.43 units on a scale
Standard Deviation 0.81
|
1.70 units on a scale
Standard Deviation 0.79
|
2.02 units on a scale
Standard Deviation 0.93
|
Adverse Events
Positive Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Neutral Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Child Interpretation Biases Assessment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Andres G Viana, Ph.D., Associate Professor
University of Houston
Phone: 832-842-0234
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place