Attention Bias Modification, Attention Control and Psychoeducation for Irritability in Children and Adolescents

Not Applicable

Completed

• Conditions: Irritability

• Registration Number: NCT03238118
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Study First Submitted: 2017-08-01
• Study First Submitted QC: 2017-08-01
• Study First Posted: 2017-08-03
• Study Start: 2018-04-18
• Primary Completion: 2020-09-24
• Study Completion: 2020-09-24
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-02
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Name	Time	Method
Mean change from baseline to endpoint in the Affective Reactivity Index	two weeks	The Affective Reactivity individual items are scored 0,1, 2, and only the first six items are summed to form the total score - the seventh is an impairment item and it is analyzed separately.
Mean change from baseline to endpoint in The Extended Strengths and Weaknesses Assessment of Normal Behavior	two weeks	The Extended Strengths and Weaknesses Assessment of Normal Behavior has been developed in order to capture variance associated with both strengths and weaknesses to generate a near-normal distribution in epidemiological samples. For each of the 30 items, evaluators assess how well the child handles emotions and behaves compared to other children of the same age - far below average, below average, slightly below average, about average, slightly above average, above average and far above average.

Trial Locations

Locations (1)

Paola Paganella Laporte; 🇧🇷 Porto Alegre, RIO Grande DO SUL, Brazil