Evaluation of CO-OP for Adolescents With Mild Intellectual Disability

Официальное название

Evaluation of The Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach for Adolescents With Mild Intellectual Disability

Обзор

Intellectual disability (ID) affects a person throughout life and includes difficulties to manage what is expected in everyday life based on age. One difficulty is to create strategies for and solve problems related to everyday occupations. Treatment options with good evidence to enhance occupational performance for persons with ID are limited. The Cognitive Orientation to Daily Occupational Performance (CO-OP) is an approach with good evidence within other diagnostic groups, i.e. adolescents with cerebral palsy. CO-OP has a unique person-centered approach where the person chooses his/her own goals and creates his/her own strategies to reach them. Initial research shows potential for CO-OP with adolescents with ID, although due to scientific flaws there is still a lack of evidence regarding feasibility and effectiveness for adolescents with ID. Based on the results with other diagnostic groups and clinical knowledge and experience, CO-OP can be assumed to be feasible and effective for adolescents with ID and to have a long term effect transferred to everyday life in a way other treatment options do not. The aim of the project is to describe and evaluate CO-OP for adolescents with mild ID. Participants will be adolescents aged 13-17 and their parents. The project is designed as a feasibility study with two qualitative, one quantitative and one mixed method data collection. The quantitative data will be ordinal and nominal data from observational and self-assessment assessments. The mixed methods include comparison between filmed sessions and the CO-OP manual, use of field notes to analyse fidelity and needs for adaptations, and comparison between the CO-OP manual and policy documents. The qualitative outcome will be experiences by the adolescents and perceptions of CO-OP by parents.

Вмешательства

• Другое The Cognitive Orientation to Daily Occupational Performance Approach
  CO-OP is a client-centred, performance-based, problem-solving focused, occupation-focused and occupation-based intervention. In CO-OP the person is guided to use a meta-cognitive strategy to find his or her own strategies for specific activities. The main purpose is to enable meta-cognitive thinking in every day activities, leading to enhanced self-efficacy, occupational performance and independency.

Первичные конечные точки

• Change in Canadian Occupational Performance Measure - performance [Срок оценки: Baseline, up to 4 weeks post intervention and 6 months post intervention]
• Change in Canadian Occupational Performance Measure - satisfaction [Срок оценки: Baseline, up to 4 weeks post intervention and 6 months post intervention]
• Change in Performance Quality Rating Scale - occupational performance quality [Срок оценки: Baseline, up to 4 weeks post intervention and 6 months post intervention]

Вторичные конечные точки (3)

• Change in General Self-Efficacy Scale - self-efficacy [Срок оценки: Baseline, up to 4 weeks post intervention and 6 months post intervention]
• Experiences of CO-OP as a patient - qualitative [Срок оценки: Up to 4 weeks post intervention and 6 months post intervention]
• Perceptions of CO-OP as a parent of a patient - qualitative [Срок оценки: Up to 4 weeks post intervention and 6 months post intervention]

Критерии участия

Study I-II

Критерии включения

• 13-17 years
• Diagnosed mild intellectual disability
• Motivation to reach self-selected goals
• Ability to identify those goals
• Possibility to meet once a week for ten weeks
• Access to a parent or significant other for support during intervention

Критерии исключения

• Movement related diagnosis (i.e. cerebral palsy or neuro muscular diseases)
• Diagnosed attention deficit hyperactivity disorder/attention deficit disorder (ADHD/ADD) or autism spectrum disorder
• Progressive diagnoses
• Need for language interpreting
• Need for alternative and augmentative communication (i.e. pictures or signs).

Study III

Критерии включения

• 13-17 years
• Diagnosed mild intellectual disability
• Completed CO-OP intervention or at lest half way trough the intervention
• Opportunity to meet physically for an interview with in a month post and 6 months post intervention.
• CO-OP intervention done with high fidelity to CO-OP format with a CO-OP therapist that has written field notes, preferrably recruited from study I-II.

Критерии исключения

• Movement related diagnosis (i.e. cerebral palsy or neuro muscular diseases)
• Diagnosed attention deficit hyperactivity disorder/attention deficit disorder (ADHD/ADD) or autism spectrum disorder
• Progressive diagnoses
• Need for language interpreting
• Need for alternative and augmentative communication (i.e. pictures or signs).

Study IV

Критерии включения

• Parents with legal guardianship that lives full- or part time with an adolescent reaching the inclusion criteria for study I who has completed CO-OP within or out of the project
• Opportunity to meet physically for an interview with in a month post and 6 months post the adolescent's completed, or at least half way through, CO-OP intervention.

Критерии исключения

• Need for language interpreting
• Need for alternative and augmentative communication (i.e. pictures or signs)
• Irregular and brief living with the adolescent comparable to less than half-time and therefore does not observe the adolescent's occupational performance enough to answer the interview questions.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швеция · 2 центра

• Region Skåne — Kristianstad
• Region Värmland — Karlstad

Идентификаторы

NCT: NCT06691698 · ORU 2024-02873-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗