- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT06691698
Evaluering av CO-OP for ungdom med lett utviklingshemming (CO-OPIF)
Evaluering av Cognitive Orientation to Daily Occupational Performance (CO-OP) tilnærming for ungdom med mild intellektuell funksjonshemming
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Elin Widmark, MSc
- Telefonnummer: +46108319064
- E-post: elin.widmark@oru.se
Studer Kontakt Backup
- Navn: Marie Holmefur, PhD
- Telefonnummer: +4619303612
- E-post: marie.holmefur@oru.se
Studiesteder
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Örebro, Sverige, 65185
- Rekruttering
- Region Örebro County
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Ta kontakt med:
- Elin Widmark
- Telefonnummer: 0108319064
- E-post: elin.widmark@oru.se
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Skåne County
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Kristianstad, Skåne County, Sverige, 29133
- Rekruttering
- Region Skåne
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Ta kontakt med:
- Elin Widmark, MSc, doctoral student
- Telefonnummer: +46108319064
- E-post: elin.widmark@oru.se
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Värmland County
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Karlstad, Värmland County, Sverige, 65185
- Rekruttering
- Region Värmland
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Ta kontakt med:
- Elin Widmark, MSc, doctoral student
- Telefonnummer: +46108319064
- E-post: elin.widmark@oru.se
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Underetterforsker:
- Elin Widmark, Doctoral student
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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 |
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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Canadian Occupational Performance Measure - performance
Tidsramme: Baseline, up to 4 weeks post intervention and 6 months post intervention
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Self-rated occupational performance in four chosen goal activities, rated 1-10 |
Baseline, up to 4 weeks post intervention and 6 months post intervention
|
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Change in Canadian Occupational Performance Measure - satisfaction
Tidsramme: 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 |
Baseline, up to 4 weeks post intervention and 6 months post intervention
|
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Change in Performance Quality Rating Scale - occupational performance quality
Tidsramme: Baseline, up to 4 weeks post intervention and 6 months post intervention
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Observed performance quality during performing four chosen goal activities thas is filmed and rated 1-10. |
Baseline, up to 4 weeks post intervention and 6 months post intervention
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in General Self-Efficacy Scale - self-efficacy
Tidsramme: Baseline, up to 4 weeks post intervention and 6 months post intervention
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Self-rated self-efficacy, 10 statements rated 1-4. |
Baseline, up to 4 weeks post intervention and 6 months post intervention
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Experiences of CO-OP as a patient - qualitative
Tidsramme: Up to 4 weeks post intervention and 6 months post intervention
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Qualitative semi-structured interviews analyzed using qualitative content analysis. |
Up to 4 weeks post intervention and 6 months post intervention
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Perceptions of CO-OP as a parent of a patient - qualitative
Tidsramme: Up to 4 weeks post intervention and 6 months post intervention
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Qualitative semi-structured interviews analyzed using phenomenographic analysis |
Up to 4 weeks post intervention and 6 months post intervention
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Feasibility: Acceptability
Tidsramme: Up to 4 weeks post intervention and 6 months post intervention
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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. |
Up to 4 weeks post intervention and 6 months post intervention
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Feasibility: Possible expansion to a new group
Tidsramme: 2024-2025
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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. |
2024-2025
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Feasibility: Adaptation
Tidsramme: Up to 1 year after intervention.
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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. |
Up to 1 year after intervention.
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Marie Holmefur, PhD, Örebro University, Sweden
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Nevrologiske manifestasjoner
- Sykdommer i nervesystemet
- Psykiske lidelser
- Neoplasmer
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Nevroatferdsmanifestasjoner
- Lymfesykdommer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Lymfom, Non-Hodgkin
- Nevroutviklingsforstyrrelser
- Lymfom
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Hemic og lymfatiske sykdommer
- Lymfom, follikulær
- Intellektuell funksjonshemming
Andre studie-ID-numre
- ORU 2024-02873-01
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