Evaluation of CO-OP for Adolescents With Mild Intellectual Disability

NCT ID: NCT06691698

Last Updated: 2025-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-16

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Intellectual Disability, Mild

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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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

Group Type EXPERIMENTAL

The Cognitive Orientation to Daily Occupational Performance Approach

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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CO-OP

Eligibility Criteria

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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


* 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.


* 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

* 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


* 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


* 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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Landstinget i Värmland

OTHER

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role collaborator

Stiftelsen Sunnerdahls Handikappfond

OTHER

Sponsor Role collaborator

Stiftelsen Sävstaholm

UNKNOWN

Sponsor Role collaborator

Majblommans riksförbund

UNKNOWN

Sponsor Role collaborator

Örebro University, Sweden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie Holmefur, PhD

Role: PRINCIPAL_INVESTIGATOR

Örebro University, Sweden

Locations

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Region Skåne

Kristianstad, Skåne County, Sweden

Site Status RECRUITING

Region Värmland

Karlstad, Värmland County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Elin Widmark, MSc

Role: CONTACT

+46108319064

Marie Holmefur, PhD

Role: CONTACT

+4619303612

Facility Contacts

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Elin Widmark, MSc, doctoral student

Role: primary

+46108319064

Elin Widmark, MSc, doctoral student

Role: primary

+46108319064

Related Links

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https://www.oru.se/forskning/forskningsprojekt/fp/?rdb=p2711

Project presentation at Orebro University website.

Other Identifiers

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ORU 2024-02873-01

Identifier Type: -

Identifier Source: org_study_id

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