Evaluation of CO-OP for Adolescents With Mild Intellectual Disability

NCT06691698 | Recruiting

• 1 other identifier: ORU 2024-02873-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Intellectual Disability, Mild

Keywords

adolescents; executive function; metacognition; mild intellectual disability; occupational therapy; occupational performance; person-centered intervention; self-efficacy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Other Outcomes (3)

• Feasibility: Acceptability

  Up to 4 weeks post intervention and 6 months post intervention

• Feasibility: Possible expansion to a new group

  2024-2025

• Feasibility: Adaptation

  Up to 1 year after intervention.

Study Arms (1)

CO-OP for adolescents with mild intellectual disability

EXPERIMENTAL

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

Interventions

The Cognitive Orientation to Daily Occupational Performance Approach OTHER

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.

Also known as: CO-OP

CO-OP for adolescents with mild intellectual disability

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.
• 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

Sponsors & Collaborators

• Örebro University, Sweden: lead
• Landstinget i Värmland: collaborator
• Göteborg University: collaborator
• Stiftelsen Sunnerdahls Handikappfond: collaborator
• Stiftelsen Sävstaholm: collaborator
• Majblommans riksförbund: collaborator

Study Sites (2)

Region Skåne

Kristianstad, Skåne County, 29133, Sweden

RECRUITING

Region Värmland

Karlstad, Värmland County, 65185, Sweden

RECRUITING

Related Links

• Project presentation at Orebro University website.

MeSH Terms

Conditions

Intellectual Disability; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Marie Holmefur, PhD

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elin Widmark, MSc

CONTACT

+46108319064; elin.widmark@oru.se

Marie Holmefur, PhD

CONTACT

+4619303612; marie.holmefur@oru.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: One of the outcomes will be assessed using video from baseline, post and 6 months post intervention, and the assessor of those videos will be blinded to the order and have no knowledge about the participant.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 15, 2024
• Study Start: January 16, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)