Evaluation of CO-OP for Adolescents With Mild Intellectual Disability
ConditionIntellectual Disability, Mild
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-17
SponsorÖrebro University, Sweden
About this trial
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
This trial does not accept healthy volunteersQualifiers
13-17 years
Diagnosed mild intellectual disability
Motivation to reach self-selected goals
Ability to identify those goals
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
The Cognitive Orientation to Daily Occupational Performance Approach
Other interventionCO-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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: CO-OP for adolescents with mild intellectual disabilityExperimental treatment 1 intervention
Trial outcomes
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 intervention2
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 intervention3
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 interventionSecondary 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 intervention2
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 intervention3
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 interventionOther 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 intervention2
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
2024-20253
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.Sponsors and contacts
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Örebro University, Sweden
Lead sponsor
Landstinget i Värmland
Collaborator
Göteborg University
Collaborator
Stiftelsen Sunnerdahls Handikappfond
Collaborator
Stiftelsen Sävstaholm
Collaborator
Majblommans riksförbund
Collaborator
Source ClinicalTrials.gov