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NCT Number: NCT06691698

Evaluation of CO-OP 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.

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Key information

Conditions

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

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Region Skåne, Kristianstad, Skåne County, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: CO-OP

Primary outcomes

  1. 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

  2. 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

  3. 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 outcomes

  1. 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.

  2. 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.

  3. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elin Widmark, MSc

CONTACT

[email protected]

+46108319064

Marie Holmefur, PhD

CONTACT

[email protected]

+4619303612

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Collaborators

  • Göteborg University
  • Landstinget i Värmland
  • Majblommans riksförbund
  • Stiftelsen Sunnerdahls Handikappfond
  • Stiftelsen Sävstaholm

Registry information

Official study title

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

Acronym: CO-OPIF

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 15, 2024
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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