Intellectual Disability, MildCO-OPIFNCT06691698
Evaluation of CO-OP for Adolescents With Mild Intellectual Disability
A study testing The Cognitive Orientation to Daily Occupational Performance Approach in people with Intellectual Disability, Mild, run by Örebro University, Sweden at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Intellectual Disability, Mild
- What is being tested?
- The Cognitive Orientation to Daily Occupational Performance Approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSweden
- Study dates
- 16 Jan 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 13Show fewer
- 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.
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Region Värmland
Karlstad, Värmland County, 65185
Elin Widmark, MSc, doctoral student, +46108319064, elin.widmark@oru.se
Elin Widmark, Doctoral student
- Recruiting
Region Skåne
Kristianstad, Skåne County, 29133
Elin Widmark, MSc, doctoral student, +46108319064, elin.widmark@oru.se
About this study
Official title: 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.
- Conditions
- Intellectual Disability, Mild
- Being tested
- The Cognitive Orientation to Daily Occupational Performance Approach
- Keywords
- adolescents, executive function, metacognition, mild intellectual disability, occupational therapy, occupational performance, person-centered intervention, self-efficacy
- Medical subject headings
- Intellectual Disability, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Cognitive Orientation to Daily Occupational Performance ApproachOther
Also called CO-OP
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: The Cognitive Orientation to Daily Occupational Performance Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Canadian Occupational Performance Measure - performance
Self-rated occupational performance in four chosen goal activities, rated 1-10
Measured: 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
Measured: 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.
Measured: Baseline, up to 4 weeks post intervention and 6 months post intervention
Secondary outcomes (3)
Change in General Self-Efficacy Scale - self-efficacy
Self-rated self-efficacy, 10 statements rated 1-4.
Measured: 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.
Measured: 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
Measured: Up to 4 weeks post intervention and 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start16 Jan 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual Disability, MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Landstinget i Värmland, Göteborg University, Stiftelsen Sunnerdahls Handikappfond, Stiftelsen Sävstaholm, Majblommans riksförbund
- Responsible party
- Sponsor
- Investigators
- Marie Holmefur, PhD, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691698
- Sponsor's protocol ID
- ORU 2024-02873-01
- Acronym
- CO-OPIF
- Status last verified
- Aug 2025
- First submitted
- 5 Nov 2024
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach for Adolescents With Mild Intellectual Disability
- ClinicalTrials.gov ID
- NCT06691698
- Acronym / sponsor ID
- CO-OPIF / ORU 2024-02873-01
- Conditions
- Intellectual Disability, Mild
- Keywords
- adolescents, executive function, metacognition, mild intellectual disability, occupational therapy, occupational performance, person-centered intervention, self-efficacy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Collaborators
- Landstinget i Värmland, Göteborg University, Stiftelsen Sunnerdahls Handikappfond, Stiftelsen Sävstaholm, Majblommans riksförbund
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CO-OP for adolescents with mild intellectual disability | Experimental | Other: The Cognitive Orientation to Daily Occupational Performance ApproachCO-OP intervention during 10 weeks. Outcomes measures at baseline, directly after and 6 months after intervention |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Cognitive Orientation to Daily Occupational Performance ApproachAlso: CO-OPCO-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 | CO-OP for adolescents with mild intellectual disability |
Primary outcome
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.
3 secondary outcomes
Change in General Self-Efficacy Scale - self-efficacy
Time frame: Baseline, up to 4 weeks post intervention and 6 months post intervention
Experiences of CO-OP as a patient - qualitative
Time frame: Up to 4 weeks post intervention and 6 months post intervention
Perceptions of CO-OP as a parent of a patient - qualitative
Time frame: Up to 4 weeks post intervention and 6 months post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Project presentation at Orebro University website.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie Holmefur, PhD principal investigator
Örebro University, Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Cognitive Orientation to Daily Occupational Performance Approach in people with Intellectual Disability, Mild, run by Örebro University, Sweden at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elin Widmark, MSc (+46108319064, elin.widmark@oru.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Canadian Occupational Performance Measure - performance (time frame: Baseline, up to 4 weeks post intervention and 6 months post intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.