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RecruitingNCT06691698CO-OPIFUpdated Aug 29, 2025

Evaluation of CO-OP for Adolescents With Mild Intellectual Disability

An interventional study of The Cognitive Orientation to Daily Occupational Performance Approach in Intellectual Disability, Mild, sponsored by Örebro University, Sweden. Recruiting at 2 sites in Sweden. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-08-29.

Sponsored by Örebro University, Sweden · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
13 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Intellectual Disability, Mild

Keywords

  • adolescents
  • executive function
  • metacognition
  • mild intellectual disability
  • occupational therapy
  • occupational performance
  • person-centered intervention
  • self-efficacy
03

In context

Intellectual Disability

363 studies on the registry are indexed under Intellectual Disability; 103 are open to participants now.

This study's planned enrollment of 60 is above the median of 53 across 236 interventional studies indexed under Intellectual Disability.

Browse Intellectual Disability studies →

Lead sponsor

Örebro University, Sweden is the lead sponsor of 84 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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

Interventions

  • OtherThe 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.

    Also known as: CO-OP

06

What researchers measure

Primary outcomes

  1. Change in Canadian Occupational Performance Measure - performance

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

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

  2. Change in Canadian Occupational Performance Measure - satisfaction

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

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

  3. 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.

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

Secondary outcomes

  1. Change in General Self-Efficacy Scale - self-efficacy

    Self-rated self-efficacy, 10 statements rated 1-4.

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

  2. Experiences of CO-OP as a patient - qualitative

    Qualitative semi-structured interviews analyzed using qualitative content analysis.

    Time frame: Up to 4 weeks post intervention and 6 months post intervention

  3. Perceptions of CO-OP as a parent of a patient - qualitative

    Qualitative semi-structured interviews analyzed using phenomenographic analysis

    Time frame: Up to 4 weeks post intervention and 6 months post intervention

Other outcomes

  1. 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.

    Time frame: Up to 4 weeks post intervention and 6 months post intervention

  2. 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.

    Time frame: 2024-2025

  3. 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.

    Time frame: Up to 1 year after intervention.

07

Study locations

2 of 2 sites recruiting
  • Region Skåne
    Kristianstad, Skåne County 29133, Sweden
    Recruiting
  • Region Värmland
    Karlstad, Värmland County 65185, Sweden
    • Elin Widmark, MSc, doctoral student · Contact · elin.widmark@oru.se · +46108319064
    • Elin Widmark, Doctoral student · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06691698
Lead sponsor
Örebro University, Sweden
Collaborators
Landstinget i Värmland, Göteborg University, Stiftelsen Sunnerdahls Handikappfond, Stiftelsen Sävstaholm, Majblommans riksförbund
Responsible party
Sponsor
First posted
Nov 15, 2024
Start date
Jan 16, 2025
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Aug 29, 2025

Study contacts

Elin Widmark, MSc
Contact
elin.widmark@oru.se
+46108319064
Marie Holmefur, PhD
Contact
marie.holmefur@oru.se
+4619303612
Marie Holmefur, PhD
principal investigator · Örebro University, Sweden

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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