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Developing and Evaluating a Meta-cognitive Intervention Amongst Adolescents With Neuro-development Disabilities (FITTED)

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ClinicalTrials.gov Identifier: NCT03618563
Recruitment Status : Completed
First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Sara Rosenblum, University of Haifa

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Adolescent Behavior Other: functional individualized therapy for teenagers with executive deficits Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The study was designed as a randomized controlled and crossover trial to evaluate the efficacy of the treatment among adolescents with EF deficits in their daily performance. The first Intervention Group (A) received the FITTED intervention. After a crossover switching trial, the second Intervention Group (B) received the FITTED intervention in order (Fig 1). An OT performed all four evaluations (Phases 1, 1a, 2, and 3) in similar environmental conditions. Another OT performed the intervention process according to the protocol. The Ethics Committee of the University of Haifa approved the study.
Masking: Single (Participant)
Masking Description: After the baseline evaluation, participants were randomly assigned to Intervention Group A or B by block randomization. For example, the first participant was allocated to Group A, the second to Group B, third to Group A, and so forth (Jadad 1998). Participants did not know to which group they belonged and had not contact with other participants during all study phases. Further, the OT who performed the participant evaluations was blinded to their treatment allocations.
Primary Purpose: Treatment
Official Title: Developing and Evaluating a Meta-cognitive Intervention Amongst Adolescents With Neuro-development Disabilities
Actual Study Start Date : October 17, 2013
Actual Primary Completion Date : December 20, 2013
Actual Study Completion Date : March 31, 2016

Intervention Details:
  • Other: functional individualized therapy for teenagers with executive deficits
    Intervention to improve self-perceived performance and performance satisfaction in daily activity goals that adolescent selected,


Primary Outcome Measures :
  1. Canadian Occupational Performance Measure (COPM) [ Time Frame: Change measures from baseline, 8 weeks and 20 weeks ]
    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.


Secondary Outcome Measures :
  1. Behavior Rating Inventory of Executive Function (BRIEF) [ Time Frame: Change measures from baseline, 8 weeks and 20 weeks ]

    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.


  2. Behavior Rating Inventory of Executive Function (BRIEF-SR) [ Time Frame: Change measures from baseline, 8 weeks and 20 weeks ]

    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.


  3. Participation Measure and Environment for Children and Youth (PEM-CY) questionnaire [ Time Frame: Change measures from baseline and 8 weeks ]
    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).

  4. Computerized Penmanship Evaluation Tool (ComPET, previously referred to as POET) [ Time Frame: Change measures from baseline and 8 weeks ]
    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.

  5. WebNeuro [ Time Frame: Change measures from baseline and 8 weeks ]
    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.

  6. the children's cooking task (CCT) [ Time Frame: Change measures from baseline and 8 weeks ]

    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.




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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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Responsible Party: Sara Rosenblum, Professor in the Department of Occupational Therapy, Faculty of Social Welfare, University of Haifa
ClinicalTrials.gov Identifier: NCT03618563     History of Changes
Other Study ID Numbers: FITTED
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sara Rosenblum, University of Haifa:
daily function
executive functions