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Completed

NCT Number: NCT03238118

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.

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Key information

Conditions

Irritability

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Paola Paganella Laporte

Porto Alegre, Rio Grande do Sul, 90460-110, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Attention bias modification training

Other

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.

Attention Control Training

Other

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.

Psychoeducation

Other

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.

Primary outcomes

  1. 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

  1. Mean change from baseline to endpoint in the Affective Reactivity Index

    Time frame: 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.

  2. Mean change from baseline to endpoint in The Extended Strengths and Weaknesses Assessment of Normal Behavior

    Time frame: 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.

Other outcomes

  1. Anxiety: The parent- and child-report formats of the Spence Children's Anxiety Scale

    Time frame: 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.

  2. Depression: Mood and Feelings Questionnaire

    Time frame: two weeks

    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.

  3. Attention-Deficit/Hyperactivity Disorder: The Multimodal Treatment Study for Attention-Deficit/Hyperactivity Disorder Swanson - Version IV

    Time frame: two weeks

    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.

  4. Profile of Mood State

    Time frame: two weeks

    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.

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 3, 2017
Registry last updated
Oct 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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