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Clinical Trials/NCT06691698
NCT06691698
Recruiting
Not Applicable

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

Örebro University, Sweden2 sites in 1 country60 target enrollmentJanuary 16, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intellectual Disability, Mild
Sponsor
Örebro University, Sweden
Enrollment
60
Locations
2
Primary Endpoint
Change in Canadian Occupational Performance Measure - performance
Status
Recruiting
Last Updated
8 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 16, 2025
End Date
March 1, 2027
Last Updated
8 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Örebro University, Sweden
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Canadian Occupational Performance Measure - performance

Time Frame: Baseline, up to 4 weeks post intervention and 6 months post intervention

Self-rated occupational performance in four chosen goal activities, rated 1-10

Change in Canadian Occupational Performance Measure - satisfaction

Time Frame: Baseline, up to 4 weeks post intervention and 6 months post intervention

Self-rated satisfaction with performance in four chosen goal activities, rated 1-10

Change in Performance Quality Rating Scale - occupational performance quality

Time Frame: Baseline, up to 4 weeks post intervention and 6 months post intervention

Observed performance quality during performing four chosen goal activities thas is filmed and rated 1-10.

Secondary Outcomes

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

Study Sites (2)

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