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

NCT03618563 | Completed

• 1 other identifier: FITTED
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Adolescent Behavior

Keywords

daily function; executive functions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Behavior Rating Inventory of Executive Function (BRIEF)

  Change measures from baseline, 8 weeks and 20 weeks

• Behavior Rating Inventory of Executive Function (BRIEF-SR)

  Change measures from baseline, 8 weeks and 20 weeks

• Participation Measure and Environment for Children and Youth (PEM-CY) questionnaire

  Change measures from baseline and 8 weeks

• Computerized Penmanship Evaluation Tool (ComPET, previously referred to as POET)

  Change measures from baseline and 8 weeks

• WebNeuro

  Change measures from baseline and 8 weeks

Interventions

functional individualized therapy for teenagers with executive deficits OTHER

Intervention to improve self-perceived performance and performance satisfaction in daily activity goals that adolescent selected,

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• average score of 65 or higher in one of the BRIEF questionnaire indexes
• or more in the Wechsler intelligence scale for children

You may not qualify if:

• psychiatric or emotional disorders, autistic disorders, physical disabilities, or neurological diseases

Sponsors & Collaborators

• Sara Rosenblum: lead

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor in the Department of Occupational Therapy, Faculty of Social Welfare

Model Details: 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.

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: August 7, 2018
• Study Start: October 17, 2013
• Primary Completion: December 20, 2013
• Study Completion: March 31, 2016
• Last Updated: August 7, 2018

Record last verified: 2018-08