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

NCT03238118 | Completed

• 1 other identifier: 39602514700005327
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritability

Keywords

irritability; severe mood dysregulation; disruptive mood dysregulation disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mean change from baseline to endpoint in the Affective Reactivity Index

  two weeks

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

  two weeks

Other Outcomes (4)

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

  two weeks

• Depression: Mood and Feelings Questionnaire

  two weeks

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

  two weeks

Study Arms (3)

Attention bias modification training

EXPERIMENTAL

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; Other: Psychoeducation

Attention Control Training

PLACEBO COMPARATOR

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: Attention Control Training; Other: Psychoeducation

Psychoeducation

PLACEBO COMPARATOR

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

Interventions

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 bias modification training

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.

Attention Control Training

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.

Attention Control Training; Attention bias modification training; Psychoeducation

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children aged 9 to 12 years with symptoms of irritability who scored above the 90% percentile for their existing symptoms on Affective Reactivity Index

You may not qualify if:

• a diagnosis of intellectual disability.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Paola Paganella Laporte

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

Location

Study Officials

• Giovanni Salum

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants and caregivers will be blinded to the intervention and control groups. They will not be blinded to the psychoeducation group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 3, 2017
• Study Start: April 18, 2018
• Primary Completion: September 24, 2020
• Study Completion: September 24, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-10

Locations

BR (1)