Adolescent Behavior Clinical Trial
— FITTEDOfficial title:
Developing and Evaluating a Meta-cognitive Intervention Amongst Adolescents With Neuro-development Disabilities
NCT number | NCT03618563 |
Other study ID # | FITTED |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 17, 2013 |
Est. completion date | March 31, 2016 |
Verified date | August 2018 |
Source | University of Haifa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Adolescents with neuro-developmental disabilities such as attention deficit hyperactive
disorder (ADHD), specific learning disabilities (LD) and developmental coordination disorder
(DCD) display functional difficulties in all performance areas (daily functions, learning,
playing, leisure activities, and social participation). These problems hinder their ability
to perform and participate effectively in everyday life.
Difficulties in meta-cognitive components, particularly Executive Functions (EF), are the
underlying mechanisms of these disorders and challenge the functioning of this population.
Therefore it is important to refer them to occupational therapists specializing in daily
functions and individualized intervention. The proposed model for assessment and therapy,
Functional Individualized Therapy for Teenagers with Executive Deficits (FITTED) takes into
account the environmental requirements, the person (the adolescent and his pertinent issues),
this in accordance with the classifications of the International Classification of
Functioning, Disability and Health for Children and Youth (ICF-CY) (WHO, 2007) World Health
Organization, the occupational model and dynamic meta-cognitive models. FITTED serves as a
basis for an individual evaluation and intervention program that emphasizes the individual's
personal strengths and weaknesses in daily functions: Body functions (meta-cognitive - EF and
awareness); Activity in various fields and Participation in daily functions. The model will
serve as a guide for an intervention program that will be based upon determining functional
goals and achievement of these goals through meta-cognitive strategies that will allow
adolescents optimal participation in their environments.
Status | Completed |
Enrollment | 44 |
Est. completion date | March 31, 2016 |
Est. primary completion date | December 20, 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 10 Years to 18 Years |
Eligibility |
Inclusion Criteria: - average score of 65 or higher in one of the BRIEF questionnaire indexes - 70 or more in the Wechsler intelligence scale for children Exclusion Criteria: - psychiatric or emotional disorders, autistic disorders, physical disabilities, or neurological diseases |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sara Rosenblum |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Canadian Occupational Performance Measure (COPM) | an individualized outcome measure of daily activities. Each participant identified and prioritized three meaningful daily activities in which he or she perceived performance problems to be most salient. Subsequently, the participant rated each activity on a 10-point scale (1 = not able to do at all; 10 = able to do extremely well) for self-perceived performance capacity (COPM-P) and for performance satisfaction (COPM-S). Significant improvement was considered as a change of at least two points between measures. | Change measures from baseline, 8 weeks and 20 weeks | |
Secondary | Behavior Rating Inventory of Executive Function (BRIEF) | a parents' report consisting of 86 items, designed to evaluate the control levels of EF. Parents rate their child's behavior on a three-point Likert scale (1) never, (2) sometimes, (3) often. Eight scales are obtained in two indexes: a Metacognition Index (MI) containing five sub-scales; Initiate, Working Memory, Plan/Organize, Organization of Materials, Monitor; a Behavioral Regulation Index (BRI) containing three subscales: Inhibit, Shift, and Emotional Control. T-scores at or above 65 are considered clinically significant in terms of dysexecutive functions. |
Change measures from baseline, 8 weeks and 20 weeks | |
Secondary | Behavior Rating Inventory of Executive Function (BRIEF-SR) | A self-report questionnaire used to assess EF in 11-18-year-olds. Eighty statements are included in the Behavioral Regular Index (BRI) in 4 subdomains (inhibition, shifting, emotional control and monitoring), and in 4 subdomains of the Metacognition Index (MI), (working memory, planning/organization, organization of materials, and task-complete). The BRI and MI scores are combined to constitute an overall Global Executive Composite (GEC). A standard score of 65 and above indicates a deficit. |
Change measures from baseline, 8 weeks and 20 weeks | |
Secondary | Participation Measure and Environment for Children and Youth (PEM-CY) questionnaire | questionnaire that includes 25 items focused on participation in broad types of activities at home (10 items), school (5 items), and community (10 items) setting. For each item, the parents reports on three dimensions of the child's participation: 1) frequency (8 point scale, from never (0) to daily (7); 2) level of involvement (5 point scale, from minimally involved (1) to very involved (5)); and 3) the parent's desire for change in the child's participation (yes or no, if yes, the parents can select whether he or she desire a change in frequency, level of involvement' and/or broader variety). | Change measures from baseline and 8 weeks | |
Secondary | Computerized Penmanship Evaluation Tool (ComPET, previously referred to as POET) | This standardized and validated non-language dependent handwriting assessment utilizes a digitizing tablet, on-line data collection and analysis software. In the current study, the adolescents were requested to copy a paragraph from a document placed in front of them onto an A4-sized lined paper affixed to the surface of a WACOM Intuos II x-y digitizing tablet (404 X 306 X 10 mm), while using a wireless electronic pen with a pressure-sensitive tip (Model GP-110). Displacement, pressure, and pen tip angle were sampled at 100 Hz via a 1300 MHz Pentium (R) M laptop computer. The primary outcome measures consisted of temporal, spatial, and pressure measures for each writing stroke, as well as performance over the entire paragraph. The task was performed in Hebrew, which progresses from right to left. | Change measures from baseline and 8 weeks | |
Secondary | WebNeuro | WebNeuro is a computerized neuropsychological test. It is a screening tool designed to emphasize cognitive function and its effects in different populations. This computerized assessment allows us to build a person's profile over time as there are several versions that allow for repeated measurement at several time points throughout the intervention. WebNeuro taps the following domains of cognitive function: sensorimotor, memory, executive, attention, and emotion perception (social cognition). For most tests, scoring of responses was conducted using an automated software program. | Change measures from baseline and 8 weeks | |
Secondary | the children's cooking task (CCT) | a performance-based evaluation developed by Chevignard et al. (2009) to assess EF and multitasking abilities. The manual, developed in French, was translated into English (Poncet et al., 2015), including the psychometric properties that were examined in two papers (Chevignard et al., 2009, 2010). Each subject was asked to prepare two simple recipes (a chocolate cake and a fruit cocktail). Ingredients and utensils were laid out on the table with an instruction page and a folder with six recipes presented in the same manner (i.e., title, illustrated list of ingredients, and numbered, illustrated preparation steps). The participants were expected to find the two correct recipes among the four distracters. The examiner wrote down the participant's actions and comments and then rated and classified them. |
Change measures from baseline and 8 weeks |
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