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Trial record 2 of 51 for:    psychoeducation | Not yet recruiting Studies

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

This study is not yet open for participant recruitment.
Verified August 2017 by Hospital de Clinicas de Porto Alegre
Sponsor:
ClinicalTrials.gov Identifier:
NCT03238118
First Posted: August 3, 2017
Last Update Posted: August 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre
  Purpose
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.

Condition Intervention
Irritability Other: Attention bias modification training Other: Attention Control Training Other: Psychoeducation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
Participants and caregivers will be blinded to the intervention and control groups. They will not be blinded to the psychoeducation group.
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Comparing Attention Bias Modification, Attention Control and Psychoeducation for Irritability in Children and Adolescents

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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 Outcome Measures:
  • 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.

  • Depression: Mood and Feelings Questionnaire [ Time Frame: two weeks ]
    The Mood and Feelings Questionnaire is a 33-item questionnaire based on 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.

  • Attention-Deficit/Hyperactivity Disorder: The Multimodal Treatment Study for Attention-Deficit/Hyperactivity Disorder Swanson, Nolan, and Pelham, 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.

  • 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.


Estimated Enrollment: 140
Anticipated Study Start Date: August 15, 2017
Estimated Study Completion Date: November 15, 2018
Estimated Primary Completion Date: March 15, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Attention bias modification training
For attention-toward-positive, stimuli are colour-pictures of 16 angry and 16 happy faces (half female) from the NimStim set. 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: 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.

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: 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.

Detailed Description:
Children with high levels of irritability have showed significant bias towards threating faces. Computerized training programs have showed to be able to sucessfully 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   9 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03238118


Contacts
Contact: Giovanni Salum 5551999722298 gsalumjr@gmail.com
Contact: Paola Laporte 5551995058406 paola_laporte@yahoo.com.br

Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Giovanni Salum Federal University of Rio Grande do Sul
  More Information

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03238118     History of Changes
Other Study ID Numbers: 39602514700005327
First Submitted: August 1, 2017
First Posted: August 3, 2017
Last Update Posted: August 3, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital de Clinicas de Porto Alegre:
irritability
severe mood dysregulation
disruptive mood dysregulation disorder