Clinical trial NCT03238118: Attention Bias Modification, Attention Control and Psychoeducation for Irritability in Children and Adolescents
Official title: Randomized Clinical Trial Comparing Attention Bias Modification, Attention Control and Psychoeducation for Irritability in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritability
Keywords: irritability
severe mood dysregulation
disruptive mood dysregulation disorder
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 140
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A) The first sub-group (n=60) will participate in the intervention group (the attention bias modification training) and will receive psychoeducation; B) The second sub-group (n=60 children) will participate in the attention control condition and will receive psychoeducation; C) The third sub-group (n= 20) will receive only psychoeducation. Children will be randomly assigned to one of these three groups. Both children and parents will be blind to group assignment.

Parents will provide written informed consent for children's participation. This study was approved by the Ethics Committee of Hospital de Clinicas de Porto Alegre.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean change from baseline to endpoint in the "Irritability Subscale" of The Multidimensional Assessment of Preschool Disruptive Behavior (mean values)
timeFrame: two weeks
Secondary outcomes:
measure: Mean change from baseline to endpoint in the Affective Reactivity Index
timeFrame: two weeks
measure: Mean change from baseline to endpoint in The Extended Strengths and Weaknesses Assessment of Normal Behavior
timeFrame: two weeks
Other outcomes:
measure: Anxiety: The parent- and child-report formats of the Spence Children's Anxiety Scale
timeFrame: two weeks
measure: Depression: Mood and Feelings Questionnaire
timeFrame: two weeks
measure: Attention-Deficit/Hyperactivity Disorder: The Multimodal Treatment Study for Attention-Deficit/Hyperactivity Disorder Swanson - Version IV
timeFrame: two weeks
measure: Profile of Mood State
timeFrame: two weeks
Locations:
city: Porto Alegre
country: Brazil
facility: Paola Paganella Laporte
state: RIO Grande DO SUL
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Giovanni Salum
role: PRINCIPAL_INVESTIGATOR
References: