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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-18

Study Completion Date

2020-09-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Multimodal Intervention Program for Children With Attention Deficits (Child ViReal Support Program)

NCT05391698

Attention Deficit Attention Deficit Disorder With Hyperactivity

COMPLETED NA

Efficacy of Psychotherapy Treatment of Children With Tics

NCT02144870

Tic-Disorder

UNKNOWN NA

Computerized Working Memory Training in Children With ADHD and Comorbid Tourette Syndrome

NCT02732496

Attention-Deficit/Hyperactivity Disorder Tourette Syndrome

COMPLETED NA

The Effectiveness of an Attention-based Intervention for School Aged Autistic Children With Anger Regulating Problems

NCT05221515

Autism Spectrum Disorder

COMPLETED NA

Behavior Therapy for Irritability in Autism

NCT04654260

Autism Spectrum Disorder Irritability Disruptive Behavior +4 more

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Irritability

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Participants and caregivers will be blinded to the intervention and control groups. They will not be blinded to the psychoeducation group.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Attention bias modification training

Intervention Type 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.

Psychoeducation

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Attention Control Training

Intervention Type 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

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Psychoeducation

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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