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

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

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.

Study Overview

• Status: Completed
• Conditions: Irritability
• Intervention / Treatment: Other: Attention bias modification training; Other: Psychoeducation; Other: Attention Control Training

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 Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RIO Grande DO SUL
    • Porto Alegre, RIO Grande DO SUL, Brazil, 90460-110
      • Paola Paganella Laporte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Attention bias modification training; For attention-toward-positive, stimuli are colour-pictures of 16 angry and 16 happy faces (half female). Each happy face is presented 10 times, and each angry face presented 80 times across trials, balanced across the different positions in the 3 × 3 matrix. This yielded 160 training trials (two blocks of 80 trials). Children had to mouse-click on the happy face within the 3 × 3 matrix of angry faces as quickly and as accurately as possible. The matrix disappeared after the child mouse-clicked on the correct face and the next trial began.	Other: Attention bias modification training; Participants will complete the assigned attention-training task three times a week for two weeks (six sessions), yielding 960 trials. Each session consists of three parts: evaluating the individual baseline, training and testing. Participants will also be required to complete a self-report assessment before and after each session. Participants will be evaluated at baseline, the end of week 1 and at the end of week 2 by blind investigators. Psychoeducation Participants will receive psychoeducation once a week for two weeks. Participants will also be required to complete a self-report assessment before and after each session of psychoeducation. Participants will be evaluated at baseline, the end of week 1 and at the end of week 2 by blind investigators.; Other: Psychoeducation; Participants will receive psychoeducation once a week for two weeks. Participants will also be required to complete a self-report assessment before and after each session of psychoeducation. Participants will be evaluated at baseline, the end of week 1 and at the end of week 2.
PLACEBO_COMPARATOR: Attention Control Training; For attention-training-control, stimuli are 20 colour-pictures of individual birds and flowers used in prior visual-search tasks with children. Children mouse-clicked on the bird presented amongst flowers as quickly and accurately as possible. Other task parameters were similar to the attention-toward-positive task (160 training trials). No performance feedback is given in either condition.	Other: Psychoeducation; Participants will receive psychoeducation once a week for two weeks. Participants will also be required to complete a self-report assessment before and after each session of psychoeducation. Participants will be evaluated at baseline, the end of week 1 and at the end of week 2.; Other: Attention Control Training; Attention Control Training Participants will complete the assigned attention-training task three times a week for two weeks (six sessions), yielding 960 trials. Each session consists of three parts: evaluating the individual baseline, training and testing. Participants will also be required to complete a self-report assessment before and after each session. Participants will be evaluated at baseline, the end of week 1 and at the end of week 2 by blind investigators. Psychoeducation Participants will receive psychoeducation once a week for two weeks. Participants will also be required to complete a self-report assessment before and after each session of psychoeducation. Participants will be evaluated at baseline, the end of week 1 and at the end of week 2 by blind investigators.
PLACEBO_COMPARATOR: Psychoeducation; Psychoeducation is an intervention that is characterized by informing the participant of their irritability symptoms. The goal is to teach participants how to understand their symptoms, explain their treatment modalities, recognize signs that may lead to a possible crisis, and provide tips and strategies on how to deal with irritability.	Other: Psychoeducation; Participants will receive psychoeducation once a week for two weeks. Participants will also be required to complete a self-report assessment before and after each session of psychoeducation. Participants will be evaluated at baseline, the end of week 1 and at the end of week 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline to endpoint in the "Irritability Subscale" of The Multidimensional Assessment of Preschool Disruptive Behavior (mean values)	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.	two weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline to endpoint in the Affective Reactivity Index	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.	two weeks
Mean change from baseline to endpoint in The Extended Strengths and Weaknesses Assessment of Normal Behavior	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.	two weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety: The parent- and child-report formats of the Spence Children's Anxiety Scale	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.	two weeks
Depression: Mood and Feelings Questionnaire	The Mood and Feelings Questionnaire is a 33-item questionnaire based on "Diagnostic and Statistical Manual of Mental Disorders" (DSM)-III-R criteria for depression. Consists of a series of descriptive phrases regarding how the subject has been feeling or acting recently. Codings reflect whether the phrase was descriptive of the subject most of the time, sometimes, or not at all in the past two weeks.	two weeks
Attention-Deficit/Hyperactivity Disorder: The Multimodal Treatment Study for Attention-Deficit/Hyperactivity Disorder Swanson - Version IV	The items from the DSM-IV (1994) criteria for Attention-Deficit/Hyperactivity Disorder are included for the two subsets of symptoms: inattention (items 1-9) and hyperactivity/impulsivity (items 11-19). Also, items are included from the DSM-IV criteria for Oppositional Defiant Disorder (items 21-28) since it often is present in children with Attention-Deficit/Hyperactivity Disorder.	two weeks
Profile of Mood State	The Profile of Mood State contains 65 adjectives rated by participants on a 5-point scale. Six factors are derived that include tension, depression, anger, fatigue, vigor and confusion.	two weeks

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Giovanni Salum, Federal University of Rio Grande do Sul

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 18, 2018
• Primary Completion (ACTUAL): September 24, 2020
• Study Completion (ACTUAL): September 24, 2020

Study Registration Dates

• First Submitted: August 1, 2017
• First Submitted That Met QC Criteria: August 1, 2017
• First Posted (ACTUAL): August 3, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2020
• Last Update Submitted That Met QC Criteria: October 2, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: irritability; severe mood dysregulation; disruptive mood dysregulation disorder
• Other Study ID Numbers: 39602514700005327

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No