Clinical trial NCT06691698: Evaluation of CO-OP for Adolescents With Mild Intellectual Disability
Official title: Evaluation of The Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach for Adolescents With Mild Intellectual Disability
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intellectual Disability, Mild
Keywords: adolescents
executive function
metacognition
mild intellectual disability
occupational therapy
occupational performance
person-centered intervention
self-efficacy
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
Collaborators: name: Landstinget i Värmland
name: Göteborg University
name: Stiftelsen Sunnerdahls Handikappfond
First posted: 2024-11-15
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Change in Canadian Occupational Performance Measure - performance
timeFrame: Baseline, up to 4 weeks post intervention and 6 months post intervention
measure: Change in Canadian Occupational Performance Measure - satisfaction
timeFrame: Baseline, up to 4 weeks post intervention and 6 months post intervention
measure: Change in Performance Quality Rating Scale - occupational performance quality
timeFrame: Baseline, up to 4 weeks post intervention and 6 months post intervention
Secondary outcomes:
measure: Change in General Self-Efficacy Scale - self-efficacy
timeFrame: Baseline, up to 4 weeks post intervention and 6 months post intervention
measure: Experiences of CO-OP as a patient - qualitative
timeFrame: Up to 4 weeks post intervention and 6 months post intervention
measure: Perceptions of CO-OP as a parent of a patient - qualitative
timeFrame: Up to 4 weeks post intervention and 6 months post intervention
Other outcomes:
measure: Feasibility: Acceptability
timeFrame: Up to 4 weeks post intervention and 6 months post intervention
measure: Feasibility: Possible expansion to a new group
timeFrame: 2024-2025
measure: Feasibility: Adaptation
timeFrame: Up to 1 year after intervention.
Locations:
city: Kristianstad
country: Sweden
facility: Region Skåne
state: Skåne
city: Karlstad
country: Sweden
facility: Region Värmland
state: Värmland
Study officials:
affiliation: Örebro University, Sweden
name: Marie Holmefur, PhD
role: PRINCIPAL_INVESTIGATOR
References: