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Clinical Trials/NCT03238118
NCT03238118
Completed
N/A

Randomized Clinical Trial Comparing Attention Bias Modification, Attention Control and Psychoeducation for Irritability in Children and Adolescents

Hospital de Clinicas de Porto Alegre1 site in 1 country140 target enrollmentApril 18, 2018
ConditionsIrritability

Overview

Phase
N/A
Intervention
Not specified
Conditions
Irritability
Sponsor
Hospital de Clinicas de Porto Alegre
Enrollment
140
Locations
1
Primary Endpoint
Mean change from baseline to endpoint in the "Irritability Subscale" of The Multidimensional Assessment of Preschool Disruptive Behavior (mean values)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The aim of this project is to evaluate the efficacy of an attention bias modification training if compared to an attention control and psychoeducation to reduce the symptoms of irritability among children with high levels of irritability.

Detailed Description

Children with high levels of irritability have showed significant bias towards threatening faces. Computerized training programs have showed to be able to successfully modify these biases in children with mood and anxiety disorders. Of particular importance, a study examined the effects of attention training towards positive stimuli on attention biases and anxiety symptoms in pediatric anxiety disorders. In the attention-towards-positive condition, children searched picture arrays for a happy face amongst angry faces. In the attention-training control condition, children searched for a bird amongst flowers. This study showed significantly greater reductions in clinician-rated diagnostic severity and number of diagnoses of anxiety with that training. However, no study has investigated the role of these training in children and adolescents with high levels of irritability The present project, aims to examine the effects of the attention bias modification training and compare to attention-training control condition and psychoeducation in children with high levels of irritability.

Registry
clinicaltrials.gov
Start Date
April 18, 2018
End Date
September 24, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • children aged 9 to 12 years with symptoms of irritability who scored above the 90% percentile for their existing symptoms on Affective Reactivity Index

Exclusion Criteria

  • a diagnosis of intellectual disability.

Outcomes

Primary Outcomes

Mean change from baseline to endpoint in the "Irritability Subscale" of The Multidimensional Assessment of Preschool Disruptive Behavior (mean values)

Time Frame: two weeks

The Multidimensional Assessment of Preschool Disruptive Behavior is a developmentally sensitive questionnaire, which is used to assess temper loss in terms of tantrum features and anger regulation. A total of 39 items are rated in terms of frequency over the past month: 0 = Never in the past month; 1 = Rarely (less than weekly); 2 = Some days (1-3 days per week); 3 = Most days (4-6 days); 4 = Daily; and 5 = Multiple times per day.

Secondary Outcomes

  • Mean change from baseline to endpoint in the Affective Reactivity Index(two weeks)
  • Mean change from baseline to endpoint in The Extended Strengths and Weaknesses Assessment of Normal Behavior(two weeks)

Study Sites (1)

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