Irritability Clinical Trial
Official title:
Randomized Clinical Trial Comparing Attention Bias Modification, Attention Control and Psychoeducation for Irritability in Children and Adolescents
Verified date | October 2020 |
Source | Hospital de Clinicas de Porto Alegre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 140 |
Est. completion date | September 24, 2020 |
Est. primary completion date | September 24, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 9 Years to 12 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Paola Paganella Laporte | Porto Alegre | RIO Grande DO SUL |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Anxiety: The parent- and child-report formats of the Spence Children's Anxiety Scale | 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. | two weeks | |
Other | Depression: Mood and Feelings Questionnaire | 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. | two weeks | |
Other | Attention-Deficit/Hyperactivity Disorder: The Multimodal Treatment Study for Attention-Deficit/Hyperactivity Disorder Swanson - Version IV | 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. | two weeks | |
Other | Profile of Mood State | 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. | two weeks | |
Primary | 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 | Mean change from baseline to endpoint in the Affective Reactivity Index | 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. | two weeks | |
Secondary | Mean change from baseline to endpoint in The Extended Strengths and Weaknesses Assessment of Normal Behavior | 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. | two weeks |
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