Evaluation of CO-OP for Adolescents With Mild Intellectual Disability (CO-OPIF)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Intellectual Disability, Mild
• Intervention / Treatment: Other: The Cognitive Orientation to Daily Occupational Performance Approach

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elin Widmark, MSc; Phone Number: +46108319064; Email: elin.widmark@oru.se
• Study Contact Backup: Name: Marie Holmefur, PhD; Phone Number: +4619303612; Email: marie.holmefur@oru.se

Study Locations

• Sweden
  • Skåne County
    • Kristianstad, Skåne County, Sweden, 29133
      • Recruiting
      • Region Skane
      • Contact: Elin Widmark, MSc, doctoral student; Phone Number: +46108319064; Email: elin.widmark@oru.se
  • Värmland County
    • Karlstad, Värmland County, Sweden, 65185
      • Recruiting
      • Region Värmland
      • Contact: Elin Widmark, MSc, doctoral student; Phone Number: +46108319064; Email: elin.widmark@oru.se
      • Sub-Investigator: Elin Widmark, Doctoral student

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Study I-II

Inclusion criteria

• 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

Exclusion criteria:

• 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

Inclusion criteria:

• 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.

Exclusion criteria:

• 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

Inclusion criteria:

• 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.

Exclusion criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CO-OP for adolescents with mild intellectual disability; CO-OP intervention during 10 weeks. Outcomes measures at baseline, directly after and 6 months after intervention

Other: 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.; Other Names: CO-OP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Canadian Occupational Performance Measure - performance	Self-rated occupational performance in four chosen goal activities, rated 1-10	Baseline, up to 4 weeks post intervention and 6 months post intervention
Change in Canadian Occupational Performance Measure - satisfaction	Self-rated satisfaction with performance in four chosen goal activities, rated 1-10	Baseline, up to 4 weeks post intervention and 6 months post intervention
Change in Performance Quality Rating Scale - occupational performance quality	Observed performance quality during performing four chosen goal activities thas is filmed and rated 1-10.	Baseline, up to 4 weeks post intervention and 6 months post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in General Self-Efficacy Scale - self-efficacy	Self-rated self-efficacy, 10 statements rated 1-4.	Baseline, up to 4 weeks post intervention and 6 months post intervention
Experiences of CO-OP as a patient - qualitative	Qualitative semi-structured interviews analyzed using qualitative content analysis.	Up to 4 weeks post intervention and 6 months post intervention
Perceptions of CO-OP as a parent of a patient - qualitative	Qualitative semi-structured interviews analyzed using phenomenographic analysis	Up to 4 weeks post intervention and 6 months post intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Acceptability	Acceptability will be evaluated by structured interviews. The interview consists of five yes/no questions and a 10 point scale on how much effort the CO-OP intervention required. Data will be on nominal and ordinal level.	Up to 4 weeks post intervention and 6 months post intervention
Feasibility: Possible expansion to a new group	Qualitative text analysis in which contents of the CO-OP manual will be compared with norms and values in the national policy documents for children and youth habilitation. This is carried out to evaluate whether it would be possible to expand this intervention to a new group of patients (adolescents with mild intellectual disability). The data collection is not related to the individual participants.	2024-2025
Feasibility: Adaptation	Whether the CO-OP approach needs any adaptations in order to be feasible for adolescents with mild intellectual disability will be evaluated. This will be done by collecting field notes written by CO-OP therapists and a text analysis with descriptive comparison between notes and the CO-OP manual.	Up to 1 year after intervention.

Collaborators and Investigators

• Sponsor: Örebro University, Sweden
• Collaborators: Göteborg University; Stiftelsen Sunnerdahls Handikappfond; Landstinget i Värmland; Stiftelsen Sävstaholm; Majblommans riksförbund
• Investigators: Principal Investigator: Marie Holmefur, PhD, Örebro University, Sweden

Publications and helpful links

Helpful Links

• Project presentation at Orebro University website.

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: adolescents; occupational therapy; executive function; self-efficacy; metacognition; occupational performance; mild intellectual disability; person-centered intervention
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Neurobehavioral Manifestations; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Neurodevelopmental Disorders; Lymphoma; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hemic and Lymphatic Diseases; Lymphoma, Follicular; Intellectual Disability
• Other Study ID Numbers: ORU 2024-02873-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No