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RecruitingNCT06691698ClinicalTrials.gov record

Evaluation of CO-OP for Adolescents With Mild Intellectual Disability

Intellectual Disability, Mild

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type
Interventional
Phase
Not applicable
Age range
13 years - 17 years
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
60 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.
Understand screening

Treatment, groups and participation

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Assignment
Not applicable
Masking
No masking
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

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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

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.

Secondary measures

Change in General Self-Efficacy Scale - self-efficacy

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

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

Experiences of CO-OP as a patient - qualitative

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

Qualitative semi-structured interviews analyzed using qualitative content analysis.

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

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

Qualitative semi-structured interviews analyzed using phenomenographic analysis

Other measures

Feasibility: Acceptability

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

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.

Feasibility: Possible expansion to a new group

Time frame: 2024-2025

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.

Feasibility: Adaptation

Time frame: Up to 1 year after intervention.

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.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (3)

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3 locations

Region SkåneKristianstad, Skåne County, SwedenRecruiting
Elin Widmark, MSc, doctoral studentCONTACTelin.widmark@oru.se+46108319064
View location on map ↗
Region VärmlandKarlstad, Värmland County, SwedenRecruiting
Elin Widmark, MSc, doctoral studentCONTACTelin.widmark@oru.se+46108319064
Elin Widmark, Doctoral studentSUB_INVESTIGATOR
View location on map ↗
Region Örebro CountyÖrebro, SwedenRecruiting

Study team and timeline

Lead sponsor
Örebro University, Sweden
Study start
Jan 16, 2025 Actual
Primary completion
2027-12 Estimated
Study completion
2027-12 Estimated
First posted
Nov 15, 2024 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

Elin Widmark, MScCONTACTelin.widmark@oru.se+46108319064
Marie Holmefur, PhDCONTACTmarie.holmefur@oru.se+4619303612
Official study title

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

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026